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.