Randomized controlled double‐blind study of a cleanser composed of 5‐aminolevulinic acid and peptides on mild and moderate acne vulgaris

BACKGROUND: Existing treatments of acne vulgaris may be complicated or elicit undesirable side effects. Therefore, new and safe therapeutic modalities are needed. OBJECTIVES: We investigated the effects of a cleanser with 5-aminolevulinic acid and peptides on mild to moderate acne vulgaris. METHODS: Sixty volunteers with mild to moderate acne vulgaris (IGA grade II-III) were randomly assigned to treatment or control groups of thirty respectively. Participants cleansed their faces twice a day for 8 weeks with either a cleanser with 5-aminolevulinic acid and peptides (treatment) or with basic cleanser (control). The number of acne lesions (comedones, papules, pustules, and nodules), Michaelson's acne severity, and IGA were measured every 2 weeks and patient satisfaction and adverse events at week 8. RESULTS: Mean number of inflammatory acne lesions in treatment group decreased from 5.9 at baseline to 4.5 at week 4 and 4.1 at week 8 (in particular, P < .05). The mean number of noninflammatory lesions in treatment group decreased from 11.4 at baseline to 8.8 at week 4 and 7.4 at week 8 (in particular, P < .05). The mean value of Michaelson's acne severity index and IGA in treatment group also decreased from baseline to week 4 and week 8 (both in particular, P < .05). Investigator's assessment and patient satisfaction in treatment group at week 8 were better than control group. Adverse events in two groups were similar. CONCLUSIONS: We think the cleanser with 5-aminolevulinic acid and peptides is a useful and safe therapeutic agent for mild to moderate acne vulgaris.