Spironolactone demonstrated notable safety and tolerability in females aged <21 years with refractory acne, according to a recent study from the Mayo Clinic.
Spironolactone is a safe and effective treatment for female adolescent acne patients whose disease has not responded to topical therapies, according to the findings of a recently published retrospective study.1
Recognizing the lack of data on the use of spironolactone as treatment for acne in the pediatric population, researchers from the Mayo Clinic, Rochester, Minn., undertook an electronic search of their institution’s medical records to identify females aged <21 years who received spironolactone for at least three months as treatment for acne. Their analysis included patients aged 14 to 20 years old (median, 19) with a median European classification system acne severity grade of 3 (severe papulopustular/moderate nodular acne). A majority of the patients were unresponsive to previous oral treatments for acne (94%) and received spironolactone as monotherapy (69%).
Spironolactone treatment was associated with limited side effects during usage periods ranging from three to 45 months (median seven months) and had a benefit in 64 (80%) patients, including in 73.9% of the subgroup of patients with grade 4 (severe nodular/conglobate) acne. In the overall population, the acne responses were rated as complete (≥90%) in 18 (22.5%) patients, >50% in 29 patients (36.3%), and <50% in 17 patients (21.3%).
“In a previous study we found that females over the age of 21 responded well to spironolactone therapy.2 Considering those results along with the results of the present study, we recommend a trial of spironolactone to treat any female aged 14 years or older who has grade 2 to 4 acne that has not responded to topical therapy,” says Somaira Nowsheen, M.D., Ph.D.
She adds, “Spironolactone, however, should not be used in females who are pregnant.”
Dr. Nowsheen collaborated on the studies as a participant in the Mayo Clinic Medical Scientist Training Program. She is a dermatology resident currently completing her transitional year at Gundersen Medical foundation, La Crosse, Wis.
The daily dose of spironolactone received by the patients in the adolescent study ranged from 25 to 200 mg with a median of 100 mg. Time to initial response occurred at a median of five months and maximal responses were observed at a median of five months.
“Based on these data, we recommend that spironolactone be used at a dose of 100 mg and for a trial of least three months,” Dr. Nowsheen says.
The investigators also compared various characteristics of the patients who responded to spironolactone with those of the non-responders to see if they could identify factors associated with a better outcome. Although statistical analyses were not performed, the numerical data showed that compared with the non-responders, higher percentages of patients whose acne improved had involvement on the jawline (70.3% vs. 56.3%), cyclic flares (75.0% vs. 56.3%), and were on an oral contraceptive pill (65.6% vs. 37.5%).
“Based on these observations, we recommend that females being treated with spironolactone also be placed on an oral contraceptive pill,” Dr. Nowsheen says.
She adds, “Our data did not show much benefit from concomitant antibiotic treatment.
Therefore, we recommend that physicians should refrain from prescribing antibiotics to help reduce emergence of bacterial resistance.”
Tolerability of spironolactone was good and comparatively better than in the adult population that was the subject of the previous study. In the pediatric cohort, three patients (3.8%) experienced side effects that resulted in treatment discontinuation. The side effects included rash, breast tenderness, diarrhea, and headache.
“Side effects with spironolactone that have been reported in the literature include hyperkalemia, gastrointestinal disturbances, and irregular menses. Considering that very few patients in our study experienced side effects and eventually had to stop treatment and because no patients developed symptoms suggestive of hyperkalemia, we do not recommend any routine laboratory monitoring for patients being treated with spironolactone for acne,” wrote the study authors.
Disclosure: Dr. Nowsheen has no relevant financial interests to disclose.
1. Roberts EE, Nowsheen S, Davis DMR, et al. Use of spironolactone to treat acne in adolescent females. Pediatr Dermatol. 2020 Oct 3. Online ahead of print.
2. Roberts EE, Nowsheen S, Davis MDP, et al. Treatment of acne with spironolactone: a retrospective review of 395 patients at Mayo Clinic, 2007-2017. J Eur Acad Dermatol Venereol. 2020 Feb 20. Online ahead of print.