Isotretinoin 5 mg daily for low-grade adult acne vulgaris--a placebo-controlled,
randomized double-blind study.
Author(s): Rademaker M(1), Wishart JM, Birchall NM.
Affiliation(s): Author information:
(1)Dermatology Department, Waikato Hospital, Hamilton, New Zealand.
Publication date & source: 2014, J Eur Acad Dermatol Venereol. , 28(6):747-54
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.
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