Isotretinoin 5 mg daily for low-grade adult acne vulgaris--a placebo-controlled, randomized double-blind study.

Abstract

BACKGROUND:

Despite acne persisting into adulthood in up to 50% of the population, very few therapeutic studies have been performed in this age group.

OBJECTIVES:

To assess the efficacy of 5 mg/day isotretinoin in adult acne.

METHODS:

An investigator initiated, industry-sponsored, randomized, double-blind, placebo-controlled, parallel-group clinical study of isotretinoin 5 mg/day in the treatment of low-grade adult acne for 16 weeks followed by an open-label phase of 16 weeks. Group 1 received 32 weeks of 5 mg isotretinoin/day; Group 2 first received 16 weeks of placebo, followed by 16 weeks open-label 5 mg isotretinoin/day. Patients were followed for a further 10 weeks off treatment. The primary end-point was the difference in acne lesion count and disability score after 16 weeks isotretinoin compared to placebo. Secondary end-points included differences in these counts/scores after 32 weeks of isotretinoin compared to baseline, and after 10 weeks off treatment, compared to end of treatment (week 32).

RESULTS:

There were highly significant differences (P < 0.0001) in acne lesion count, Dermatology Life Quality Index and self-assessment after 16 weeks of isotretinoin, compared to placebo (both per protocol and intention to treat). Acne lesions fell significantly, within 4 weeks of 5 mg isotretinoin/day (Group 1) and continued to fall during 32 weeks of treatment [acne lesion count (mean ± SD): 11.3 ± 8.1 (baseline), 3.6 ± 5.5 (week 16), 1.3 ± 3.1 (week 32), P < 0.0001)]. There was a similar significant reduction in acne lesion count in Group 2, but only from week 20, 4 weeks after starting open-label 5 mg isotretinoin. Adverse effects were minimal.

CONCLUSIONS:

Isotretinoin 5 mg/day is effective in reducing the number of acne lesions, and improving patients dermatologic quality of life, with minimal adverse effects.

• Authors: M Rademaker, J M Wishart, N M Birchall
• Journal: Journal of the European Academy of Dermatology and Venereology : JEADV (J Eur Acad Dermatol Venereol) Vol. 28 Issue 6 Pg. 747-54 (Jun 2014) ISSN: 1468-3083 [Electronic] England
• PMID: 23617693 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2013 The Authors Journal of the European Academy of Dermatology and Venereology © 2013 European Academy of Dermatology and Venereology.

Chemical References

• Dermatologic Agents
• Placebos
• Isotretinoin

Topics

• Acne Vulgaris (drug therapy)
• Adult
• Dermatologic Agents (administration & dosage)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Isotretinoin (administration & dosage)
• Male
• Middle Aged
• Placebos
• Severity of Illness Index