Dermatologists may be first to encounter patients. Learn how to recognize signs.

Skin symptoms associated with rare cancer

a weekly glimpse into what your patients may be reading in the media about skin health.

features stories on “aesthetic trauma” and why your scalp might hurt sometimes. Also, 

provides an in-depth guide to managing keratosis pilaris during the winter and 

dives into why vitamin C can make your skin sensitive to the sun. Finally, 

reveals what to know before mixing skincare ingredients and investigates if dermarolling the scalp can help with hair loss.

A Guide to Managing Keratosis Pilaris This Season

Does Vitamin C Make Your Skin Sensitive to the Sun? Here's What Experts Have to Say

Can Dermarolling Your Scalp Help With Hair Loss?

What Dermatologists Want You To Know Before You Mix Skincare Ingredients

Here's Why Your Hair and Scalp Hurts Sometimes

Articles

This week’s edition of The Mainstream Patient features stories on dermarolling for hair loss, vitamin C and skin sensitivity, how to manage keratosis pilaris, plus more.

The Mainstream Patient: November 30

Poll

POLL: Are you feeling the effects of burnout?

A new bonus episode of our editorial podcast, The Cutaneous Connection, focusing on the COVID-19 cosmetic surgery boom;

The latest content from our December issue;

New videos on racial disparities in melanoma awareness;

A brand new edition of The Mainstream Patient;

Check back with our website frequently so you don’t miss any of the latest dermatology news.

A glimpse at what to expect from Dermatology Times this week.

What’s new on Dermatology Times: November 30- December 4

In case you missed it, some of this week’s featured content includes stories on how a vitamin D deficiency may be linked to acne, how infant eczema impacts food allergy plans, shingles, a novel fluorescence-advanced videodermatoscopy for characterization of Demodex mites, platelet-rich plasma for anti-aging, how JAKs might predict risk of psoriasis, challenges with mohs micrographic surgery in pediatric patients, three-year dupilumab data for treatment of psoriasis and psoriatic arthritis, plus more.

POLL: Will you be hosting or attending a gathering for Thanksgiving?

The Cutaneous Connection- Episode 12: Antibiotics for Acne

The potential for antibiotic resistance have caused some physicians to be wary of the drug class when prescribing an acne treatment regimen. Christopher Bunick, M.D., Ph.D., clears the air around antibiotic use for acne and discusses his research of narrow-spectrum antibiotics.

This week’s edition of The Mainstream Patient features stories on alpha arbutin as a brightening skincare ingredient, a new search tool that pairs skin of color patients with dermatologists, how to handle facial erythema, plus more.

Infants with eczema may require different approaches to preventing food allergies, including early introduction of peanuts to increase oral exposure to allergens before skin exposure.

An extensive literature review looks at the dermatoses that are connected to video game play.

Three-year eczema data show sustained safety, efficacy

New study data shows that in adults with atopic dermatitis, dupilumab has performed as expected, with continued efficacy and no new safety signals.

Shingles (herpes zoster, or HZ) is more than just a skin manifestation. The condition is also commonly associated with hearing, vision, and balance problems among other symptoms.

Ixekizumab demonstrates long-term efficacy

Ixekizumab demonstrated long-term efficacy in treating psoriasis and psoriatic arthritis across five years, according to data presented by Eli Lilly at the 29th annual European Academy of Dermatology and Venereology (EADV) Congress.

Investigators assessed results combining oxymetazoline and four different lasers in a recent phase 4 study. Results demonstrate improvement from baseline in Clinician Erythema Assessment (CEA) score.

Novel device characterizes mite infestations

Fluorescence-advanced videodermatoscopy (FAV, Adamo Srl) for characterization of Demodex mites suggests that it can be a useful tool in the clinical evaluation and management of patients with Demodex-related skin diseases.

Mohs micrographic presents challenges in kids

While Mohs micrographic surgery is well established as a safe and effective therapeutic modality in adult patients, it is not as commonly used in pediatric populations. There are unique challenges to performing Mohs surgery on pediatric patients, especially with patient cooperation. Multidisciplinary planning may be needed.

Puzzling PRP possibilities and dermatology

The use of platelet-rich plasma (PRP) has grown in popularity over the past few years. Zoe Diana Draelos, M.D., explains the anti-aging benefits of PRP and how it is impacting dermatology.

Study links vitamin D deficiency with acne

Patients with acne should be screened for vitamin D deficiency and insufficiency, according to researchers of a recent study investigating vitamin D's link to acne.

Genetic polymorphisms may increase psoriasis susceptibility, according to a study that found patients who have the G allele in the JAK1 gene have twice the risk of developing psoriasis, and for those with the JAK3 allele, the risk rises nearly 2-fold.

ICYMI, some of the content featured this week includes challenges with mohs micrographic surgery in pediatric patients, how a vitamin D deficiency may be linked to acne, three-year dupilumab data for treatment of PsO and PsA, plus more.

Weekly Roundup: November 23-27

John Jesitus is a medical writer based in Westminster, CO.

Variants in Janus kinase (JAK)1 rs310241 and JAK3 rs3008 may increase susceptibility to psoriasis, according to a recent study.

JAKs have attracted significant interest in dermatology, says corresponding author Aya M. AlOrbani, MD, lecturer in dermatology at Cairo University Hospital, Cairo, Egypt. “But the focus has mainly been on JAKs as a therapeutic target.”

Clinical studies have shown that JAK inhibition improves diseases such as psoriasis, vitiligo and alopecia areata. “But not many studies have assessed how genetic changes or polymorphisms in the JAK genes could affect psoriasis,” she says.

To further explore the genetic architecture of psoriasis, investigators in the Kasr Al-Ainy Psoriasis Unit (KAPU), Cairo University Hospital, compared blood samples from 150 Egyptian patients with psoriasis and samples from 120 age- and sex-matched healthy volunteers.

Using the polymerase chain reaction (PCR)-restriction fragment length polymorphism technique, investigators screened samples for nucleotide polymorphisms in JAK1 rs310241 and JAK3 rs3008. They chose these variants partly because the JAK1 rs310241 polymorphism has been associated with other immune-mediated illnesses such as Crohn’s disease and Behçet’s disease.

Investigators noted that the GG (homozygous) genotypes of JAK1 rs310241 and JAK3 rs3008 conferred approximately 7.7-fold and 3.3-fold 

increased risk for psoriasis, respectively.

values were 0.000 and 0.003, respectively; 95% confidence intervals (CIs) were 2.8-21.5 and 1.5-6.9, respectively.

“Polymorphisms are like genetic markers," says AlOrbani. "The discovery that these polymorphisms exist may help us predict which patients are at high risk of developing psoriasis in the future.” Further down the road, she adds, this knowledge may help physicians tailor treatments to patients’ individual clinical situations. “The next step might be to study the effect of these polymorphisms on response to treatments.”

JAKs are basically secondary messengers that mediate biological signaling, she says. “Inflammatory cytokines bind to receptors, and JAK molecules are recruited.” JAK activation triggers a cascade of further signaling events involving phosphorylation of selected receptor chain tyrosines, binding of signal transcription and activator of transcription (STAT) proteins and phosphorylation of these STATs.

For both JAK polymorphisms studied, frequency of the G allele was significantly higher in patients with psoriasis versus controls and significantly increased the risk of psoriasis. “Patients who had the G allele in the JAK1 gene had twice the risk of developing psoriasis, and those with the JAK3 allele had a 1.7-fold increased risk,” says AlOrbani.

Regarding gender, researchers noted no relationship with the JAK1 variant. However, 

the JAK3 rs3008 mutant variant occurred more commonly in male patients. “This was quite interesting, because the distinction in gender with genetic polymorphisms hasn’t been studied extensively before.” One paper noted gender differences in expression of certain major histocompatibility complex (MHC) genes in psoriatic arthritis. Another study showed that the association between rs887466 and psoriasis may differ in men and women, and that the influence of rs1062470 on disease severity is also gender-dependent.

The only other study that has assessed JAK polymorphisms in patients with psoriasis was conducted in Korea, says AlOrbani. “Unlike us, these researchers did not find a difference in polymorphisms in psoriasis patients versus healthy controls in the JAK1 and JAK3 genes.”

 How- ever, the Korean study detected both protective and susceptibility loci in JAK2.

“Ethnicities differ," she says. "The JAK polymorphisms might make a difference in studies repeated in different populations.”

Aya M. AlOrbani, MD, reports no relevant financial interests.

Sayed KS, El-Komy MHM, Shehata H, et al. JAK1 rs310241 and JAK3 rs3008 genotypes may increase susceptibility to psoriasis: a case control study [published online before print September 2, 2020]. 

Kim SY, Hur MS, Choi BG, et al. A preliminary study of new single polymorphisms in the T helper type 17 pathway for psoriasis in the Korean population. 

JAKs may predict psoriasis risk 

Vitamin D deficiencies are more frequent in people with acne than in healthy controls, report Ghadah Alhetheli and her coauthors in a first-ever study

 on this topic in the Kingdom of Saudi Arabia. “This difference is statistically significant with 

-value=0.003,” adds Alhetheli, MD, assistant professor, Department of Dermatology and Cutaneous Surgery, College of Medicine, Qassim University, Buraidah, Saudi Arabia. However, researchers found no significant difference between lower serum 25-hydroxyvitamin D (25 OH) levels and the severity of acne, nor were there substantive variations based on age, gender and sun exposure.

“The precise purpose of vitamin D has yet to be established,” writes Alhetheli and her col- leagues. However, because of vitamin D's regulatory effect on the immune system as well as its antioxidant and anti-comedogenic properties, deficiencies could contribute to the pathogenesis of acne.

 Alhetheli's cross-sectional study evaluates serum levels of vitamin D through a representative sample and investigates any correlation with acne severity.

They conducted their study in outpatient dermatology clinics at Qassim University, Saudi Arabia between October 2016 and March 2017 to minimize the effect of seasonal variations on serum vitamin D levels. They enrolled 68 patients with acne vulgaris (27 male, 41 female) and 50 matched healthy controls (24 male, 26 female). Subjects in the patient and control groups had not taken any vitamin D supplementation and were not suffering from any comorbidity or complication of vitamin D deficiency.

Acne grading was classified as mild in 21 patients (30.88%), moderate in 24 (38.24%), and severe in 21 (30.88%). Inclusion criteria required that male and female patients had been diagnosed with acne vulgaris according to the global acne grading system (GAGS) score. Baseline demographics show that patients with acne were younger than healthy controls, with a mean standard deviation (SD) for males with acne in the study of 20.7 ± 3.8 and 21.3 ± 3.6 for females with acne versus 39.8 ± 11.8 for males in the control group and 39.8 ± 14.85 for females.

Blood samples were collected from patients’ veins and analyzed within 24 hours of sampling using the Roche Cobas e411 (Roche Diagnostic Systems, Rotkreuz, Switzerland). Serum 25-hydroxyvitamin D3 [25 (OH) D] in patients and controls were categorized into adequate(>20 ng/mL), inadequate (12–20 ng/ mL), or deficient (<12 ng/mL),

 following the guidelines of the Food and Nutrition Board of Medicine.

“Our results indicate that serum concentrations of vitamin D in controls were significantly higher than those in acne vulgaris patients (

-value = 0.003),” writes Alhetheli. “These results are in line with several other studies that found no elevation of serum vitamin D levels in acne patients.”

 She adds that the study data show no relationship between sun exposure and improvement in vitamin D readings in patients with acne.

“This can be explained by several factors, such as the impact of psychological distress on patients with acne’s avoidance of spending extended periods outdoors. This suggests a possible explanation of low vitamin D levels in patients with acne vulgaris,” writes Alhetheli. “These results were consistent with Lim et al who revealed that lower levels of serum vitamin D in severe acne vulgaris patients might be due to psychological stress.

“We found no significant association between vitamin D deficiency and gender (

-value = 0.199),” says Alhetheli. “The results of our study indicate the mean value of vitamin D was abetted higher in moderate acne (31.4±6.9) than in mild and severe acne. (26±9.4 and 28.4±6.7, respectively). This difference was not statistically significant (

-value =0.067), perhaps due to the small sample size of our study. Also, we found no significant relationship between vitamin D deficiency and the severity of acne vulgaris.”

She adds, “This study reveals a statistical significantly low serum vitamin D levels in patients with acne vulgaris. This highlights the importance of screening patients with acne for vitamin D insufficiency and deficiency... Further clinical trials are needed to determine if acne treatment with both topical vitamin D analogs and vitamin D supplementation is of significant effect.”

The authors report no conflicts of interest in this work.

1. AlhetheliG, ElneamAIA,AlsenaidA,Al-DhubaibiM.VitaminDLevelsinPatientswith and without Acne and Its Relation to Acne Severity: A Case-Control Study. Clin Cosmet Investig Dermatol. 2020;13:759-765 https://doi.org/10.2147/CCID.S271500

Institute of Medicine, Food and Nutrition Board. 

Dietary Reference Intakes for Calcium and Vitamin D

Yildizgören MT, Togral AK. Preliminary evidence for vitamin D deficiency in nodulocystic acne. 

. 2015;6(1):e983687. doi:10.4161/derm.29799

mparison of vitamin D levels in patients with and withoutAcne:aCase-ControlStudyCombinedwitharandomizedcontrolledtrial. 

. 2016;11(8): e0161162. doi:10.1371/journal.pone.0161162

Toossi P, Azizian Z, Yavari H, Fakhim T H, Amini S H, Enamzade R. Serum 25- hydroxy vitaminD levels in patients with acne vulgaris and its association with disease severity. 

. 2015;12(3):238–242. doi:10.11138/ ccmbm/2015.12.3.238

Patients with acne should be screened for vitamin D deficiency and insufficiency, according to researchers of a recent study investigating vitamin D's link to acne. 

Study links vitamin D deficiency with acne 

Zoe Diana Draelos, M.D., is a consulting professor of dermatology, Duke University School of Medicine, Durham, N.C. She is investigator, Dermatology Consulting Services, High Point, N.C., and a Dermatology Times Editorial Advisor and co-medical editor.


PRP stands for platelet rich plasma. The normal platelet count in human blood is 150,000- 350,000/microliter. PRP is defined as one million platelets per microliter in a small volume of plasma with a full complement of clotting factors. There are seven key growth factors in PRP: platelet-derived growth factors (PDGFaa, PDGFbb, PDGFab), transforming growth factors (TGF-b1, TGFb2), vascular endothelial growth factor (VEGF), and epithelial growth factor (EGF). Cellular mitogenesis and angiogenesis are both upregulated by PRP, making it useful in facial rejuvenation.

PRP is obtained from freshly drawn blood with an added anticoagulant. The blood is centrifuged twice. The first spin, known as the hard spin, separates the red blood cells from the plasma containing the platelets, white blood cells, and clotting factors. Three layers result from the hard spin: an upper layer containing platelets and white blood cells, a middle layer known as the buffy coat containing white blood cells, and a bottom layer containing red blood cells. The red blood cell layer is removed and discarded.

The second spin, known as the soft spin, separates the platelet-rich plasma in the bottom of the tube from the platelet-poor plasma (PPP) in the top of the tube by removing more red blood cells.


PRP works through degranulation of the alpha granules in platelets, which contain the growth factors. It is ideal to collect PRP in an anticoagulated state for the growth factors to remain active, which explains the need to draw the blood into a tube containing sodium citrate. The biologically active cellular components such as the growth factors are preserved within the platelet when the platelet is held in an inactive state.

Upon activation of the platelet, the granules then fuse to the cell membrane, activating the secretory growth factors, which bind to the transmembrane receptors of target cells, such as mesenchymal stem cells, fibroblasts, endothelial cells, and epidermal cells. This binding activates intracellular signal proteins that express a gene sequence directing cellular proliferation, collagen synthesis, extracellular matrix formation, and numerous other pathways to promote healing and repair processes.

There are many conflicting reports in the literature about the efficacy of PRP. If the PRP is not properly prepared, there will be no biologic effect. This could be due to improper centrifuge use with a standard laboratory centrifuge rather than specialized U.S. Food and Drug Administration (FDA)-cleared equipment with validated processes.

In dermatology, PRP is used via direct injection into the face as the “vampire facial” popular with celebrities. However, topical PRP is the next horizon. However, it must be put into a suitable vehicle that must be refrigerated for twice-daily facial application as a treatment product. Refrigerated (4 degrees C) topical PRP preparations have been shown to be stable for 90 days. At that time the patient must come back to the office for another phlebotomy and PRP preparation session. The vehicle must be specially formulated at the correct pH and with specially selected preservatives that will not destroy the PRP. Doctors should caution patients that PRP topical should be used only by the patient for whom it was prepared, not for other family members or friends since it is a blood-containing product.

PRP is safe in dermatology because it is autologous, thus concerns about immune rejection are a nonissue. PRP contains the same materials present in the bloodstream that induce clotting, except in higher concentration. The growth factors function by activating a cytoplasmic signal that promotes normal gene expression. Because of that, topical PRP represents the first biologically active personalized skin care product.

The use of platelet-rich plasma (PRP) has grown in popularity over the past few years. Zoe Diana Draelos, M.D., explains the anti-aging benefits of PRP and how it is impacting dermatology. 

Although Mohs micrographic surgery (MMS) has long been established as a safe and effective therapeutic modality for the treatment of a variety of skin tumors in adults, little is known regarding its use in children and adolescents. A recent review study

 looked at the unique challenges encountered when employing this technique in the pediatric population and highlighted how clinicians can best circumvent these obstacles in order to help facilitate the appropriate use of Mohs in children.

Typically performed in an out-patient setting, Mohs involves surgical excision and intraoperative assessment of tumor margins by the surgeon. The procedure is characterized by realtime histopathologic margin control and the ability to spare healthy tissue, particularly in cosmetically sensitive areas, resulting in better cosmetic outcomes as well as high cure rates. Although occurring less commonly than in adults, aggressive cutaneous tumors are also seen in children and Mohs can provide significant advantages in terms of margin control and minimization of surgical margins.

“In the pediatric population, this can be especially beneficial given the patients’ small body surface areas, and tissue preservation can be instrumental in helping to avoid functional and cosmetic morbidity. Mohs has not yet become first-line treatment in the pediatric population for challenging skin tumors. As such, I believe there needs to be an increased awareness amongst dermatologists and pediatricians who care for these patients regarding the benefits of Mohs as well as the challenges that are particular to this age group and how these challenges can be best overcome to provide optimal patient care,” says Hanieh Zargham, M.D., Division of Dermatology, Montreal General Hospital, McGill University Health Center, Montreal, Canada.

Dr. Zargham and colleague Amor Khachemoune, M.D., recently performed a comprehensive systematic review of the PubMed and EMBASE electronic databases including English, Spanish and French language literature articles that reported on the clear specification of the use of ‘slow Mohs’ and ‘modified Mohs’, and the use of this technique in patients younger than 18 years of age. In the final analysis, 87 articles were identified that included 111 patients ranging in age from 6 weeks to 17 years (median age 11 years), and a total of 123 resected tumors. A predisposing comorbidity was noted in 10 percent of patients (n=11) with the most common being xeroderma pigmentosum (n=3). The most common tumor treated was dermatofibrosarcoma protuberans (n=62), followed by basal cell carcinoma (n=30), and most common location of lesions was the head and neck, followed by the trunk and extremities.

Data showed that 12 patients underwent general anesthesia, 7 had local anesthesia, and one patient had conscious sedation, while all other articles did not specify the means of anesthesia. Three patients reported complications consisting of a cellulitis, a seroma and a minor wound dehiscence and only one patient had a recurrence noted at 44 months post-op. The researchers found that the most commonly cited challenges in the application of Mohs in the pediatric population included patient cooperation, concerns for safety of prolonged general anesthesia, availability of a Mohs surgery service in the pediatric setting, and access to a histopathology lab experienced in MMS sectioning.

Performing any surgical procedure, especially a longer one such as Mohs, can be particularly difficult in children and each age group has their own unique set of challenges. There are several challenges regarding the procedural logistics of Mohs in children however, according to Dr. Zargham, the biggest one may be the unpredictability of patient cooperation, especially when performed under local anesthesia.

“While younger children are usually upset about being restrained, older children usually have an anticipation of pain that can lead to anxiety and an unwillingness to cooperate, which can make the process difficult and impact time constraints of the surgical staff and healthcare facility,” Dr. Zargham says.

Screening a child’s psychological and developmental status during a preoperative consultation is important in assessing likelihood of cooperation. According to Dr. Zargham, clinicians should remember that there are several different pharmacological (i.e., injection techniques minimizing pain) and non-pharmacological approaches to facilitate patient cooperation. To the latter, the combination of swaddling and sweet solutions as well as hypnosis with imagery can be used to immobilize infants and toddlers during surgery, and distraction methods can be used for older children.

If the procedure cannot be performed under local anesthesia, then the discussion about general anesthesia can be undertaken. In these cases, multidisciplinary planning including dermatologists, pediatricians and other healthcare workers involved in the care of the child, preoperative imaging, ‘slow Mohs’, and using multiple cryostats for larger tumors can all be helpful in decreasing procedure time. In addition, using ‘slow Mohs’ with permanent sections is helpful when access to an MMS lab is limited.

“There may be numerous challenges to overcome when performing Mohs in children but we need to have a better understanding of these challenges and really think about practical ways how some of these challenges can be overcome so that we can facilitate the appropriate use of Mohs in children and provide the best patient care to our pediatric patients,” Dr. Zargham says.

1. Zargham H, Khachemoune A. Systematic review of Mohs micrographic surgery in children: identifying challenges and practical considerations for successful application. Am Acad Dermatol.2020 Oct 1;S0190-9622(20)32645-1. doi: 10.1016/j.jaad.2020.09.052.Online ahead of print.

Mohs micrographic presents challenges in kids 

Cheryl Guttman Krader is a contributor to Dermatology Times, Ophthalmology Times, and Urology Times.

Experience evaluating fluorescence-advanced videodermatoscopy (FAV, Adamo Srl) for characterization of Demodex mites suggests that it can be a useful tool in the clinical evaluation and management of patients with Demodex-related skin diseases, according to investigators who used FAV to describe the morphological features of Demodex infestation and compared them with results using reflectance confocal microscopy (RCM) in a recently published paper

“FAV is a commercially available, noninvasive, real-time, videodermoscopy system that is both affordable and easy to use,” says Diego Fernandez-Nieto, M.D., Department of Dermatology Ramón y Cajal University Hospital, Madrid, Spain.

“Our study shows that with its high magnification (500x), the device enables observation of different parts of Demodex mites and counting of the number of mites present at each follicle,” he says. “Furthermore, it allows faster estimation of mite density compared with the use of RCM that has been tested as a noninvasive alternative to standardized superficial skin biopsy (SSSB) for detecting and quantifying Demodex. Considering its advantages and capabilities, we believe that FAV could have a role for detecting Demodex infestation and evaluating response to treatments targeting the mites and that it will be adopted for many other applications in the future.”

The FAV system is manufactured in several different versions that are designed to be suitable for videodermoscopy, videocapillaroscopy, videotrichoscopy, and even videoentomology. Dr. Fernandez-Nieto notes that it is mainly used for evaluating melanocytic and non-melanocytic skin cancers. In those applications, it has the added benefit of being able to evaluate the vascularization pattern due to the high absorption and afterwards emission of fluorescence by the hemoglobin at the wavelength of the probe (405 nm ± 5 nm), he says.

“FAV has also been used for skin evaluation in fungal and parasitic infections, including scabies. We had access to this new technology for skin examination during a trial period at our center. Because of its versatility, high amplification and especially because it allows rapid visualization, we were interested in studying its ability to characterize Demodex,” he tells 

The evaluation was performed in six patients with clinical suspicion of having a Demodex-related disease, including three individuals with pityriasis folliculorum and three with papulopustular rosacea. All of the patients had undergone previous SSSB that documented the presence of >5 mites/cm

As reported by Dr. Fernandez-Nieto and colleagues, under FAV the Demodex mites were identified within the hair infundibulum as “roundish bright structures” when they were vertically oriented. Mites positioned at an oblique angle were seen as tubular dark structures surrounded by a whitish halo. The researchers note that the latter description corresponds to the appearance of the mites on RCM and that the whitish halo represented the mite’s exoskeleton.

Adjustment of the FAV system’s penetration depth made it possible to visualize the mite’s opisthosoma and gnathosoma, including the gut cells within the opisthosoma, and to estimate mite length.

“The FAV system allows counting of individual mites. With its field of view of 340 micrometers, mite density can be estimated quickly with just a few movements of the probe,” Dr. Fernandez-Nieto says. “We believe it is an equally reliable but easier and faster method than RCM or SSSB to evaluate mite density.”

 Dr. Fernandez-Nieto has no relevant financial interests to disclose.

1. Fernandez-Nieto D, et al. J Eur Acad Dermatol Venereol. 2020. Sep 14. Epub ahead of print.

Treatment with oxymetazoline (RHOFADE, EPI Health) as adjunctive therapy with energy-based therapy may offer a safe and well-tolerated option for reducing facial erythema in patients with moderate-to-severe persistent facial erythema associated with rosacea.

A recent phase 4, open-label, interventional study

 evaluated the safety and tolerability of oxymetazoline hydrochloride cream 1% (oxymetazoline) when used alongside energy-based therapies such as lasers and intense pulsed light (IPL). E­fficacy assessments were exploratory.

“These therapies can effectively manage vascular signs of the disease, such as telangiectasia and persistent erythema, by selectively targeting and thermally damaging dysregulated blood vessels. However, not all patients respond to energy-based therapies,” says Emil Tanghetti, M.D., Center for Dermatology and Laser Surgery, Sacramento, California, lead author on the study.

He adds that some patients may require more than one treatment, which could add “substantial” costs. Energy-based therapies may result in adverse side effects including unwanted purpura or erythema 

. They also have limited e­fficacy in reducing diffuse erythema associated with acne rosacea due to the small caliber of vessels, which are more di­fficult to target, according to the study.

“A combination approach to treatment including both pharmacological and physical approaches may allow more effective management of the vascular manifestations of rosacea than utilization of any one treatment modality as monotherapy,” says Tanghetti.

Oxymetazoline hydrochloride cream, an -1Aadrenoceptor agonist, already has U.S. Food and Drug Administration (FDA) approval for the topical treatment of persistent facial erythema associated with rosacea in adults

. Phase 3 clinical trials (Randomized EValuation of the Effects of Anacetrapib Through Lipid-modification (REVEAL), which evaluated data at 29 days

, showed a single daily application of oxymetazoline to be well tolerated. safe and effective in the treatment of moderate to severe persistent facial erythema of rosacea.

For the current study, eligible patients with moderate-to-severe facial erythema associated with rosacea received one of four energy-based therapies on day one and day 29: Excel V (Cutera, Brisbane, CA) potassium titanyl phosphate (KTP) laser; Palomar Icon (Cynosure, Westford, MA) IPL therapy; the pulsed-dye laser Vbeam Perfecta (Syneron-Candela, Mississauga, Ontario, Canada; PDL-Vbeam); or the pulsed-dye laser Cynergy (Cynosure; PDLCynergy). A total of 46 patients (mean age, 51.1 years; 78.3% female) enrolled in this study. Similar numbers of patients received each of the energy-based therapies in addition to oxymetazoline, according to Tanghetti.

Each study center was assigned a specific device to utilize during the study based on the current expertise and other devices already in place. The investigator’s current standard of practice determined the protocol followed for each laser treatment. Rather than using randomization or stratification, patients were assigned to an energy-based therapy based on their study site.

Patients in the study received a once-daily application of oxymetazoline beginning on day three and continuing through day 27. Following instructions from study staff and an instructional video, participants applied a pea-sized amount of oxymetazoline topically to the face at approximately the same time day. However, on study visit days, they applied the cream after completing predose study assessments and procedures. They underwent a washout of oxymetazoline on day 28 before receiving energy-based therapy the following day.

Daily application of oxymetazoline was re-initiated on day 31 and continued until study end on day 56. Investigators asked patients who discontinued the study to return on the last study visit day for end-of-study data assessment.

Tanghetti and his fellow investigators evaluated improvement from baseline in Clinician Erythema Assessment (CEA) score, patient satisfaction measures, incidence of treatment- emergent adverse events (TEAEs), and worsening from baseline on dermal tolerability assessments and the Clinician Telangiectasia Assessment (CTA).

All patients demonstrated an improvement from baseline in CEA during the study.

Among all 44 evaluable patients on day one, 6 (13.6%) showed at least one-grade improvement in CEA one hour after energy-based therapy. On day three, investigators observed one-grade or greater improvement in 20 (45.5%) patients before application of oxymetazoline, and by 35 (79.5%) patients at six hours post-treatment. On day 31, 26 (60.5%) of 43 evaluable patients, demonstrated one-grade or greater improvement before application of oxymetazoline, and by 38 (88.4%) patients at six hours post-treatment.

Data shows 39 of 43 evaluable patients (90.7%) demonstrated an improvement six hours post-treatment on day 56. Most patients were satisfied or very satisfied with treatment at the end of the study, say the investigators.

In terms of adverse effects, some patients experienced worsening in dermal tolerability assessment symptoms (range: 4–21 patients; 8.7–45.7%). Worsening in CEA and CTA were each reported by three patients (6.5%) at any time during the study.

No serious, severe, or fatal TEAEs were reported.

Emil A. Tanghetti: is an investigator for Allergan and a consultant for Aclaris, Galderma, Cynosure/Hologic and Accure; David J. Goldberg: is an investigator for Allergan and has received honoraria as a speaker for Allergan; Jeffrey S. Dover: is an investigator for Allergan and has received consulting honoraria from Allergan; Roy G. Geronemus: is an investigator for Allergan, ArchiMedus, Avava, Candela, Cynosure, Cytrellis, Endo Pharmaceuticals, Galderma, Kerastem, Lutronic, Merz, New York Stem Cell Foundation, Pulse Biosystem, Revance, Sciton, and Sienna Biopharmaceuticals; is on the medical advisory board for Allergan, Candela, Cearna, Cynosure, Cytrellis, Lutronics, and Soliton; and owns stock in Cytrellis; Zane Bai: has nothing to disclose; Nancy Alvandi: was an employee of Allergan at the time of this study; Stuart D. Shanler: was an employee of Aclaris Therapeutics,Inc. at the time of this study and owns stock/stock options in that company; has received royalties from the sale of RHOFADE from Allergan/Actavis and from Aclaris, and now receives royalties from EPI Health; has a patent 7,821,049 with royalties paid, a patent8,114,898 licensed, a patent 8,420,688 with royalties paid, a patent8,673,953 licensed, a patent 8,815,929 with royalties paid, a patent8,877,793 with royalties paid, a patent 9,265,761 licensed, and a patent/Additional Unpublished Applications licensed.

1. Gether L, Overgaard LK, Egeberg A, Thyssen JP. Incidence and prevalence of rosacea: A systematic review and meta analysis.Br J Dermatol 2018;179(2):282–289.

2. Tanghetti E, Del Rosso JQ, Thiboutot D, et al. Consensusre commendations from the American Acne & Rosacea Society on the management of rosacea, part 4: A status report on physical modalities and devices. Cutis 2014;93(2):71–76.

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The Mainstream Patient: November 30

POLL: Are you feeling the effects of burnout?

What’s new on Dermatology Times: November 30- December 4

Weekly Roundup: November 23-27

JAKs may predict psoriasis risk

Skin symptoms associated with rare cancer

Study links vitamin D deficiency with acne

Puzzling PRP possibilities and dermatology

Mohs micrographic presents challenges in kids

Novel device characterizes mite infestations

Adjunctive examined for facial erythema