• Skin Diseases
• Dermatology Clinical Trials

• Skin Diseases
• Dermatology Clinical Trials
• Dermatology

Low-dose isotretinoin reduced the number of acne lesions in adult patients with acne vulgaris beginning at 4 weeks and continuing through 32 weeks, with 40% of patients remaining acne free for 3 years. Marius Rademaker, MD, Waikato Hospital, Hamilton West, New Zealand, presented data from an unpublished follow-up study that evaluated low-dose isotretinoin for the treatment of adult acne.

Adult acne affects up to 50% of the population. Conventional treatment of adult acne is frequently ineffective or unacceptable to patients, however; there is a high dissatisfaction rate due to a slow response, poor total clearance of acne, and a high relapse rate [Rademaker M et al. J Eur Acad Dermatol Venereol. 2013]. In addition, few studies have evaluated topical retinoids, systemic antibiotics, or isotretinoin in adults. The purpose of this study was to evaluate the effect of low-dose isotretinoin on low-grade adult acne vulgaris.

In this double-blind, parallel-group study, 60 patients aged 25 to 55 years with low-grade adult acne vulgaris were randomly assigned to receive 5 mg/d of isotretinoin or placebo for 16 weeks, followed by an open-label period of isotretinoin treatment for 16 weeks. Follow-up continued for an additional 10 weeks after treatment ended. The primary end point of the study was difference in acne lesion count and disability score at week 16. The secondary end points included the differences in acne lesion count and disability score at week 32 and at the final follow-up visit.

The number of acne lesions significantly decreased in the isotretinoin arm beginning at week 4 and peaked at week 32 (P < .0001), and it was maintained throughout the study, including during the off-treatment follow-up period (Figure 1).

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Figure 1.

Low-Dose Isotretinoin Treatment for Adult Acne

NS, not significant.*P < .0001 from baseline.Adapted from Rademaker M et al. Isotretinoin 5 mg daily for low-grade adult acne vulgaris—a placebo-controlled, randomized double-blind study. J Eur Acad Dermatol Venereol. 2013;28:747–754. With permission from European Academy of Dermatology and Venereology

In a follow-up study, 60% of patients reported recurrence of at least one acne lesion at a mean time of 9.1 months. Their acne, however, was less severe at recurrence than what they had experienced prior to isotretinoin treatment. As a result, 60% of patients received further treatment for their acne, including topical retinoids, doxycycline, or isotretinoin. Isotretinoin was restarted by 48% of patients for a median of 6 months, and they continued the medication for a mean of 12.4 months. At the time of the follow-up study, 21% of patients were still taking isotretinoin with a median dose of 10 mg twice per week.

In conclusion, Prof Rademaker stated that, in his opinion, the data from this study suggest that treatment of adult acne with low-dose isotretinoin is effective, because it improves acne by week 4 with continuous improvement up to week 32. In addition, 40% of patients remained acne free by 3 years, and patients reported a very high level of satisfaction. Isotretinoin was well tolerated with few adverse events.

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