Learn more about what treatments are on the rise for plaque psoriasis, the latest management advice and what trends are shaping the future of the disease. 

The changing treatment landscape of plaque psoriasis

A post hoc analysis of data from the pivotal trials investigating tazarotene 0.045% lotion (Arazlo; Ortho Dermatologics) for treating moderate to severe facial acne show the efficacy, safety, and tolerability of the novel topical retinoid formulation are robust irrespective of patient body mass index (BMI). In addition, patients in all BMI categories and particularly those who are overweight or obese benefit with improvements in acne-related quality-of-life measures.

With research presented as a poster at Maui Derm 2021,

Fran E. Cook- Bolden, MD, says the findings are important considering the growing population of overweight and obese individuals in the United States and the negative impact of both high BMI and acne on health-related quality of life.

“Results of a recent systematic review found that the prevalence of acne is higher in overweight and obese individuals compared with those in the underweight/normal weight BMI category,” according to Cook-Bolden, who is director of the Skin Specialty Dermatology and the Ethnic Skin Specialty Group at Park South Medical in the Bronx, New York, and assistant clinical professor of dermatology at Columbia University in New York, New York. “However, studies examining the potential for BMI-related differences in quality of life among patients with acne are lacking. The effect of BMI on the efficacy and safety of topical acne treatments is largely unknown. “Patients in the tazarotene pivotal trials represented a diverse population with respect to BMI and other demographic characteristics. Based on the results of this post hoc analysis, physicians can feel confident prescribing tazarotene 0.045% lotion for their acne patients, no matter their BMI,” says Cook-Bolden.

Cook-Bolden was an investigator in the tazarotene 0.045% lotion clinical trials that enrolled patients 9 years and older with moderate-to-severe acne (Evaluator’s Global Severity Score [EGSS] of 3-4) and randomized them 1:1 to treatment with either topical medication or vehicle once daily for 12 weeks. A total of 1612 patients were included in this post hoc analysis, of whom 903 were categorized as underweight/normal weight (BMI < 25 kg/m

). Compared with the lowest BMI category, the overweight and obese cohorts included higher proportions of female, Black, and Hispanic patients.

The potential for BMI-related effects on treatment response was investigated using a variety of efficacy end points, including percentage reduction in inflammatory lesions, percentage reduction in noninflammatory lesions, percentage of participants achieving treatment success (≥ 2-grade improvement from baseline in EGSS and a rating of “clear” or “almost clear”), and improvements in the Acne-Specific Quality of Life questionnaire.

In all BMI groups, patients treated with tazarotene achieved approximately a 55% to 60% reduction from baseline to week 12 in inflammatory and noninflammatory lesion counts. The difference between the tazarotene- and vehicle-treated groups was statistically significant for both end points in all BMI subgroups—except that the magnitude of reduction in inflammatory lesions was similar in the vehicle and tazarotene groups among the obese patients.

Across the 3 BMI subgroups, statistically significant differences favoring tazarotene over vehicle were observed in comparisons of treatment success rates. Treatment success rates for tazarotene-treated patients ranged from approximately 29% to 34% across the 3 BMI subgroups compared with approximately 16% to 22% for vehicle-treated patients.

Data from the quality-of-life questionnaire showed improvements in scores for all 4 domains (self-perception, role-emotional, role-social, and acne symptoms) with both vehicle and tazarotene in all BMI subgroups. In most comparisons, however, the change from baseline was greater in the tazarotene-treated patients compared with the vehicle group. The improvements in quality of life also tended to be higher in the overweight and obese patients than in those with a BMI less than 25 kg/m

“In the pivotal trials investigating tazarotene 0.045% lotion, patients in the overweight and obese BMI subgroups had numerically worse quality of life at baseline than patients in the lowest BMI group,” Cook-Bolden notes. “Findings of a previous analysis of the pooled pivotal trial data showed that participants with worse quality of life at baseline had greater improvements in quality of life at the end of the study.

“A previous analysis also found that quality-of-life improvements were greater among female versus male and Black versus White patients.

 It’s interesting that evidence exists showing that [female patients] with acne are more likely than [male patients] to develop anxiety/depression because of their condition and that acne improvement positively affects quality of life for [female patients].”

Adverse event and cutaneous safety and tolerability data were also analyzed with patients stratified by BMI; the results showed no evidence that the safety and tolerability profile of tazarotene differed among the BMI subgroups.

Cook-Bolden has served as consultant, speaker, investigator for Galderma, LEO Pharma, Almirall SA, Cassiopea SpA, and Ortho Dermatologics, and as an investigator for Encore, Foamix, Hovione, Aclaris Therapeutics Inc, and Cutanea.

Cook-Bolden FE, Green L, Keri J, et al. Impact of body mass index on efficacy, safety, and tolerability of once-daily tazarotene 0.045% lotion in patients with moderate-to-severe acne. Poster presented at: Maui Derm Live In-Person Dermatology CME Conference and Maui Derm Connect Virtual Dermatology CME Conference; January 25-29, 2021; Maui, Hawaii; virtual.

Heng AHS, Chew FT. Systematic review of the epidemiology of acne vulgaris. Sci Rep. 2020;10(1):5754. doi:10.1038/ s41598-020-62715-3

Kircik LH, Lain E, Gold M, et al. Effects of tazarotene 0.045% lotion on quality of life in patients with moderate-to-severe acne. J Drugs Dermatol. 2020;19(11):1086-1092. doi:10.36849/JDD.2020.5457

Skroza N, Tolino E, Proietti I, et al. Women and acne: any difference from males? a review of the literature. G Ital Dermatol Vene- reol. 2016;151(1):87-92.

Articles

Data from trials show tazarotene 0.045% lotion is an effective treatment for moderate to severe facial acne and improves acne-related QOL in patients across BMI categories. 


Tazarotene Excels Across BMI Categories

A recent study determined a low risk of malignancy in secukinumab for the treatment of diseases such as psoriasis, 

 and ankylosing spondylitis (AS), for up to 5 years of care.

Limited data on long-term studies regarding the use of the biologic therapy led investigators to assess the malignancy risk, led by Mark Lebwohl, MD, of Mount Sinai.

Despite previous trials indicating a possible association between secukinumab and malignancy, the long-term recurrence of the outcome was relatively infrequent, and did not increase over time.

Investigators studied the history of malignancy risk in secukinumab-treated patients, as well as the current risk in patients. Safety data was collected from secukinumab-treated patients including 10,685 with psoriasis, 2523 with PsA and 1311 with AS (n = 14,519) from 49 clinical trials.

The study safety analyses used a malignancy rate evaluation using exposure-adjusted incidence rates (EAIR) and standardized incidence ratios (SIR) using the Surveillance, Epidemiology, and End Results Program (SEER) as a reference point.

Over a five-year period, the EAIR malignancy rate in secukinumab-treated patients was 0.85/100 patient-treatment years (PTY; 95% CI, 0.74-0.98). This data corresponds to 204 patients and 23,908 PTY.

The estimate cumulative incident reporting rate was 0.27/100 PTY for malignancy in the post-marketing surveillance data, with an exposure of 285,811 PTY. An external reference population was needed as a comparative arm for observed rate and occurrence, so investigators used the general US population.

Under 2% (n = 242)of clinical trial patients had a medical history of malignancy (psoriasis, n = 168; PsA, n = 60; AS, n = 14).

The percentage of both male and female patients were comparable; 94% were white and 60% were European.

The trial population had 25 patients who reported a medical history of malignancy on secukinumab treatment (psoriasis, n = 20; PsA, n = 4; AS, n = 1).

A minority of patients (n = 38) during the clinical trial observation period reported multiple malignancies (psoriasis, n = 27; PsA, n = 10; AS, n = 1). None of the malignancy cases were lymphomas, with over half being skin cancers and the majority non-melanoma skin cancer.

Investigators believe the five-year outcomes were as expected, based on previous clinical trial data. Past trials have been inconsistent in determining the overall risk of malignancy, but the observed rate of malignancy is comparable to those expected in the general US population (SIR = 0.99; 95% CI, 0.82 - 1.19).

“The risk of malignancy events did not appear to be increased compared to the reference population for up to five years of secukinumab treatment,” investigators wrote. “Additionally, reoccurrence of malignancy and multiple malignancies occurred relatively infrequently, and the rate of malignancy did not increase over time.”

They concluded that the data supports the long-term use of secukinumab in these treatment indications.

The risk of malignancy in secukinumab‐treated psoriasis, psoriatic arthritis and ankylosing spondylitis patients: analysis of up to five‐year clinical trial and post‐marketing surveillance data

This article was initially published by our sister publication 

A study finds low risk of malignancy from secukinumab treatment for psoriasis, psoriatic arthritis and ankylosing spondylitis patients, despite limited data.

Malignancy Risk Low in Secukinumab Treatment

A new study lends support to the established clinical safety profile of 2 mg baricitinib in adult patients with atopic dermatitis.

To date, 6 double-blind, randomized, placebo-controlled studies—as well as 2 long-term extension studies—have been conducted to evaluate the safety and efficacy of the selective Janise kinase (JAK) 1 and 2 inhibitor as either a monotherapy or combination therapy.

Led by Brett King, MD, PhD, Department of Dermatology, Yale School of Medicine, an investigative team performed an integrated analysis of all 8 studies to further evaluate the baricitinib’s safety through 2.4 years of follow-up.

Their analysis included 2 datasets—one that compared baricitinib with placebo during the 16-week period in the trials, and another that reported on estimated incident rates (IRs) of adverse events in all those who received baricitinib at any time.

As such, across all clinical trials, 1598 patients received once-daily baricitinib 2 mg for 1434.2 patient-years of exposure. Furthermore, 45.6% were treated for ≥1 year, and 2.1% were treated for ≥2 years.

Compared with placebo, a higher proportion of patients experienced ≥1 treatment-emergent adverse events (57.9% vs 51.6%).

In both treatment groups, most of the events were considered mild (baricitinib 2 mg, 32.8%; placebo, 29.9%) or moderate (baricitinib 2 mg, 22.2%; placebo, 18.3%) in severity.

Even more, the placebo group saw a higher frequency of serious adverse events (2.7%, IR = 9.2) compared with the baricitinib group (1.6%, IR = 5.2).

In the placebo-controlled dataset, the most frequently reported treatment-emergent adverse events were nasopharyngitis, headache, upper respiratory tract infection, nausea, diarrhea, and herpes simplex.

As for the baricitinib-only dataset, serious adverse events were those in the Medical Dictionary for Regulatory Activities (MedDRA) system organ classes Skin and subcutaneous tissue disorders and Infections and infestations.

The investigators also reported that a similar proportion of patients in both groups discontinued the study drug due to adverse events.

Among all patients who received baricitinib, “the most common MedDRA system organ class for permanent discontinuation was Skin and subcutaneous disorders (21.4%) with 50% of these events reported as worsening of dermatitis atopic.”

The most common MedDRA system organ class leading to temporary interruptions was Infectious and infestations (61%).

However, serious infections and opportunistic infections were found to be low in frequency and similar between treatment arms. Herpes simplex was notably higher for baricitinib 2 mg (3.8%) than for placebo (2.8%), but rates decreased with extended exposure to the JAK inhibitor.

There were no reported malignancies, gastrointestinal perforations, or major adverse cardiovascular events for baricitinib in the placebo-controlled period.

In the baricitinib-only dataset, 5 malignancies were reported, as well as 2 major adverse cardiovascular events, 1 peripheral venous thrombosis, and 1 arterial thrombosis. There were no pulmonary embolisms, deep vein thromboses, or deaths.

Therefore, the investigators concluded the safety analysis was notably consistent with the already established safety profile of bariticitinib 2 mg, a recommended started dose for those with moderate-to-severe atopic dermatitis.

“The observed patterns and rates of common treatment-emergent adverse events were similar or numerically lower with prolonged exposure to baricitinib 2 mg,” they added.

Although there were few cases of major adverse cardiovascular events and other malignancies linked with baracitinib, the investigators acknowledged their longer latency period.. Therefore, a longer treatment duration can help further elucidate the true risks for these adverse events.

“Atopic dermatitis is a chronic disease and additional long-term data will be essential to further understand other potential risks with extended baricitinib 2 mg exposure,” King and team concluded.

Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials

American Journal of Clinical Dermatology.

Initial rates of common treatment-emergent adverse events from baricitinib 2 mg appear to remain stable or decrease with prolonged exposure.

Study Confirms Safety Profile of Baricitinib Dose for Atopic Dermatitis

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.

Q: What is the best way to insert a difficult pierced earring?

Piercing of the ears and other body areas has seen a tremendous resurgence in the United States and around the world. It is a form of personal expression and body adornment among many individuals wishing to wear piercing jewelry for a variety of social and emotional reasons. Pierced ears are the most common; however, recommendations for pierced-ear care can be generalized to other body piercings.

It can become difficult to insert a pierced earring for many reasons. The most common cause is simply increased friction between the ear hole and the earring. This is most easily remedied by putting petroleum jelly on the earring post and then inserting it into the ear. The petroleum jelly will lubricate the earring to reduce friction. Forcing the earring into the hole can damage the skin, creating epidermoid cysts within the earlobe that can be painful and a source of foul- smelling drainage. This occurs when a small piece of viable skin is forced beneath the skin surface, creating a cyst. Lubricating the earring with petroleum jelly is especially important in patients with earlobe cysts.

The second most common problem causing earring-insertion difficulty is a keratin plug in the earring hole from skin debris. The skin lining the earring hole continues to slough corneocytes, which can create a keratin plug. It is best to remove the plug by pushing the earring through the hole backward (pushing the earring post from the posterior earlobe to the anterior earlobe). This will remove the plug and allow earring insertion to proceed smoothly.

Q: Can you leave in pierced earrings while sleeping?

It is not advisable to sleep with pierced earrings in your ears, although many women prefer not to remove their earrings at night. The earlobe is a thin piece of skin and easily can tear if the earring becomes caught and pulled on hair or bedclothes at night. Stud- type earrings are less prone to earlobe damage than longer dangling earrings or larger hoops. It is recommended that women who prefer to wear earrings continually select a small stud for safety.

Q: How can you improve earring wear in mature individuals?

Many mature individuals discontinue wearing pierced earrings because the earlobes become thinned with age. This is due to loss of subcutaneous fat in the earlobes. Subcutaneous fat loss occurs over the entire body, but it may be most noticeable in the earlobes because the floppy lobes can no longer support an earring and tend to flip forward.

This problem can be remedied easily. One solution is to purchase larger-diameter pierced-earring stud backs that will support the earlobe. These backs can be purchased from a jeweler and worn with all stud earrings. Another option is to put a plastic disk over the posterior earlobe around the earring post, over which the back is pushed to keep the plastic disk in place. Both solutions will allow the earlobe to remain flat.

A second solution is to inject hyaluronic acid filler into the earlobe. The needle is placed into the lower rim of the earlobe, and hyaluronic acid can be injected into the center of the earlobe by using a fanning motion to fill the entire earlobe, taking care to preserve the earlobe shape. The filler should be massaged to be sure that no lumps are present and that an even, thin layer of filler has been deposited over the entire ear lobe. Since earlobes do not move, the hyaluronic acid has a long duration (9-12 months).

For most patients, it is not necessary to inject a full syringe. When injecting into other areas of the face, save 0.5 cc and inject half into each earlobe for an excellent reconstruction result. The filler will make the earlobe thicker and less likely to tear from earring use while also eliminating earlobe wrinkles from redundant skin.

In this month's Cosmetic Conundrums column, Dermatology Times Chief Medical Editor Zoe Diana Draelos, MD, discusses how to solve common challenges associated with pierced earrings.

Solving Pierced Earring Challenges 

features stories on perioral dermatitis and why millennials are opting for brow lifts over injectables. Plus, 

provides in-depth guides to fraxel lasers and microcurrent facials. Meanwhile, 

dives into how to treat “flat acne” and 

highlights one dermatologist’s skincare routine to treat her rosacea.

Everything You Need To Know About Fraxel Lasers

Everything You Need To Know About Microcurrent Facials

I Thought I Just Had Dry Skin, But It Was Actually Perioral Dermatitis

More Millennials Are Opting for Surgical Brow Lifts Over Noninvasive Treatments

Flat Acne is Trending on Skincare Reddit—But How Do You Treat it?

Derm Diaries: ‘I’m A Dermatologist With Rosacea. Here’s How I Treat It.’

This week’s edition of The Mainstream Patient features stories on fraxel lasers, microcurrent facials, perioral dermatitis, brow lifts, plus more. 

The Mainstream Patient: April 12, 2021

During the COVID-19 pandemic, the incidence of children developing Kawasaki disease (KD) was significantly higher than that for other infectious diseases, suggesting that KD arises as a result of 

 infections, investigators concluded in a recent study.

, provides evidence contradicting the dominant theory for KD development—that KD is associated with contact or droplet transmission of pathogens similar to how respiratory syncytial virus (RSV) causes respiratory tract infections and rotavirus causes gastrointestinal infections.

KD is an acute, self-limited, febrile disease predominately detected in children aged 6 months to 5 years. According to the American Heart Association, the disease is 

 by inflammation of the blood vessels, particularly the coronary artery, potentially causing permanent arterial damage, aneurisms, and heart attacks.

Past evidence has suggested that KD can occur in patients who are genetically predisposed to the disease after being exposed to certain environmental triggers. However, despite long-term research, investigators are still unsure of what exactly causes KD development.

Since February 2020, when the first outbreak of COVID-19 occurred, Japanese officials heavily encouraged handwashing, mask wearing, and social distancing and issued a state of emergency lasting from April 7 to May 25, 2020. These measures decreased the spread of SARS-CoV-2, the virus that causes COVID-19, and other pathogens transmitted through contact or droplets, giving an opportunity to investigate whether the incidence of KD did as well.

To conduct the multicenter, longitudinal, cross-sectional study, the investigators analyzed the number of admissions for KD and infectious diseases at 6 hospitals in Fukuoka, Japan and 11 nationwide hospitals between 2015 to 2020.

A total of 1649 pediatric patients with KD and 15,586 with infectious diseases were admitted. The median (interquartile range) age for patients with KD was 25 (13-43) months, and 54.6% (n = 901) were boys.

There was no significant change in the number of KD-related admissions between April and May in 2015 to 2019 compared with the same months in 2020 (mean [SD], 24.8 [5.6] vs 18.0 [4.0] monthly admissions; 27.4% decrease; adjusted incidence rate ratio [aIRR], 0.73; 95% CI, 0.48-1.10; 

Conversely, there was a significant decrease in admissions linked to contact- or droplet-transmitted respiratory (mean [SD], 157.6 [14.4] vs 39.0 [15.0] admissions per month; 75.3% decrease; aIRR, 0.25; 95% CI, 0.17-0.35; 

 < .001) and gastrointestinal (mean [SD], 43.8 [12.9] vs 6.0 [2.0] admissions per month; 86.3% decrease; aIRR, 0.14; 95% CI, 0.04-0.43; 

 < .001) infections from April to May in 2015 through 2019 compared with the same time frame in 2020.

After the Japanese COVID-19 state of emergency was lifted in June to December 2020, the number of patients with KD significantly decreased by 45% in the 6 Fukuoka hospitals and 47% in the 11 nationwide hospitals compared with the same months in 2015 to 2019. However, the decrease was not comparable to the 68.9% decrease observed for respiratory infections. A smaller 18.2% decrease was observed for gastrointestinal infections.

“These persistently low RSV and rotavirus incidence rates suggest that people continued engaging in infection-preventive behaviors (eg, physical distancing, hand washing, and wearing masks) even after the COVID-19 state of emergency was lifted,” wrote the investigators.

The investigators suggested that the persistence of KD decrease may be linked to airborne transmission partially being blocked by COVID-19 preventive measures or potential KD-causing environmental triggers were reduced as a consequence of restricted socioeconomic activity, leading to reduced motor vehicle emissions and shutdowns of power plants and factories.

The limitations associated with the study included the limited potential for generalizability and the inability to definitively determine PD pathogenesis.

“Despite these limitations, we believe that the results of this work provide intriguing clues toward clarification of the pathogenesis of KD and the establishment of preventive methods for KD,” wrote the investigators.

This article was initially published on our sister publication 

1. Hara T, Fununo K, Tamanura K, et al. Assessment of pediatric admissions for Kawasaki disease or infectious disease during the COVID-19 state of emergency in Japan. Published online April 6, 2021. Accessed April 8, 2021.

Given the high prevalence of Kawasaki disease during the pandemic, Japanese investigators determined that droplet or contact transmission of pathogens is likely not a major route causing the development of the disease.

COVID-19 Pandemic Provides Glimpse Into Potential Cause of Kawasaki Disease in Children

Poll

POLL: Have you seen a rise in aesthetic procedures at your practice since the pandemic began?

The latest articles from our April issue;

Coverage from the Inaugural Symposium for Inflammatory 

An exclusive video interview with Melissa Stenstrom on the importance of skin cancer screenings and sun protection;

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

What’s New on Dermatology Times: April 12-16

POLL: What dermal fillers do you most often inject?

This week’s edition of The Mainstream Patient features stories on sweat reduction, vitamin C serums and sensitive skin, the importance of sebum, plus more.

Study: Depression, Anxiety Reduce Likelihood of Achieving Minimal Disease Activity in PsA Patients

A new study in Arthritis Care & Research found depression and anxiety reduces the possibility of achieving minimal disease activity in patients with psoriatic arthritis.

Biologic Therapy for Psoriasis May Reduce Heart Disease

A study found psoriasis patients treated with biologic therapy had a significant reduction in high-risk plaque in heart arteries over 1 year.

New treatments continue to expand therapy options, but a cure remains elusive.

The Cyberwar Against Health Care Practices

How hackers plan to attack your practice—and what you can do about it.

The Role of Vitamin D in Keloid Scar Treatment

A recent study in the Journal of Cosmetic Dermatology examines the safety and efficacy of using vitamin D intralesional injection for the treatment of keloid scars.

Risankizumab Submitted for Regulatory Approval to FDA, EMA for Psoriatic Arthritis

AbbVie announces the submission of regulatory filings for risankizumab to the FDA and EMA seeking approval for the drug as a treatment for psoriatic arthritis.

Laser Device Purchases Are Guided by Multiple Factors

Determine whether a laser device is a good investment for a specific practice and, if so, how to choose the right piece of equipment.

The Cutaneous Connection: Episode 21- Oxytocin and Skin Aging

In this episode, Nicole Hayre, MD, FAAD, discusses her research on the link between the "love hormone" oxytocin and younger-looking skin.

Baricitinib Shows Hair Regrowth in Phase 3 Study for AA

Eli Lilly and Incyte announce results from its phase 3 study evaluating baricitinib 2 mg and 4 mg for the treatment of alopecia areata, making it the first Phase 3 study with top-line results in patients with the hair disorder.

Emerging Agents Augment Melasma Modalities

An array of agents for blocking visible light and lightening skin are joining the armamentarium to treat melasma. Despite this expanding number of therapeutic interventions, melasma is a chronic, therapeutically challenging disease for which there is no cure, so treatment plans should address both management of the disease and patient expectations.

Phase 2b Trial of Topical Isotretinoin for CI Reaches 50% Enrollment

Timber Pharmaceuticals' phase 2b trial of isotretinoin for congenital ichthyosis (CI) has reached 50% enrollment.

ICYMI, some of this week’s featured content includes stories on the cyberwar against health care practices, the link between oxytocin and skin aging, baricitinib for alopecia areata, plus more.

Weekly Roundup: April 5-9, 2021

Topical formulation could equal the efficacy of oral isotretinoin with a reduced risk of adverse effects.

Timber Pharmaceuticals has randomized 50% of patients for the Phase 2b CONTROL study (NCT04154293), according to the company’s press release.1 The study will examine the use of TMB-001 (topical isotretinoin) in patients with moderate to severe congenital ichthyosis (CI) and focuses on X-linked ichthyosis and lamellar ichthyosis. Target enrollment is 45 patients aged nine years and older. CI is a group of keratinization disorders that cause dry, thickened and scaling skin. The condition often manifests at birth.

“Oral isotretinoin has been used off-label to treat CI for decades,” says Alan Mendelsohn, MD, EVP and Chief Medical Officer at Timber Pharmaceuticals, Basking Ridge, New Jersey. “It is the only drug that has been shown to be effective through large, well-controlled clinical studies that date back to the early 1980’s. The issue with oral isotretinoin relates to safety - whereas in acne most patients can see a dramatic improvement with a short-term course of treatment at 1mg/kg/day, in CI potentially higher doses with more diffuse application are needed.”

Mendelsohn believes that by delivering adequate concentrations of isotretinoin locally, it will be possible to replicate the documented efficacy of the treatment without the safety issues of oral isotretinoin.

“The mainstays of treatment have been hydration and lubrication of the skin [such as bathing with lubricating oils, lubricating ointments] while also adding agents that are keratinolytic, i.e. temporarily remove the thickened skin [such as salicylic acid, propylene glycol, urea]. These treatments, however, relieve symptoms but do not treat the underlying conditions of increased keratinization of the skin,” says Mendelsohn.

The study’s ability to attract participants reflects the need for treatment options, he notes. Due to the coronavirus disease 2019 (COVID-19) pandemic, travel to study sites was complicated. “By introducing telemedicine and at-home photography, patients already enrolled could at least be examined remotely for changes in their skin,” says Mendelsohn.

He anticipates reviewing a full data set internally in the third quarter of 2021, with a conference with the FDA late in the fourth quarter to discuss moving on to a full phase 3 trial if results so warrant.

1. Timber Pharmaceuticals Announces 50% Enrollment in Phase 2b CONTROL Study in Congenital Ichthyosis. Timber Pharmaceuticals. 

https://www.newmediawire.com/news/timber-pharmaceuticals-announces-50-enrollment-in-phase-2b-control-study-in-congenital-ichthyosis-5216441

Timber Pharmaceuticals's phase 2b trial of isotretinoin for congenital ichthyosis (CI) has reached 50% enrollment.