BACKGROUND: The presence of sebum on the face is responsible for both facial shine and the formation of comedonal and inflammatory acne lesions. Sebum control is a goal of many OTC skin care products; however, most currently available products function by absorbing sebum from the face rather than modulating its production. OBJECTIVE: To demonstrate the effect of topical 2% niacinamide on sebum excretion rates and casual sebum production in Oriental and Caucasian populations. METHODS: Separate clinical trials were conducted in both Japan and the USA to evaluate the effect of topical 2% niacinamide in different ethnic groups. A total of 100 Japanese subjects were enrolled in a double-blind, placebo-controlled comparison between two independent balanced groups. Fifty subjects applied the 2% niacinamide moisturizer to the face for 4 weeks and 50 subjects used aplacebo moisturizer for 4 weeks, with sebum excretion rate (SER) measurements taken at baseline, week 2, and week 4. In addition, 30 Caucasian subjects were enrolled in a randomized split-face study for 6 weeks with SER and casual sebum levels (CSL) measured at baseline, week 3, and week 6. RESULTS: The results of the Japanese study demonstrated that the SER of the two groups was not significantly different at baseline, but the 2% niacinamide treated group demonstrated significantly lowered SER after 2 and 4 weeks of application. The results were somewhat different in the Caucasian study. After 6 weeks of treatment, the CSL was significantly reduced, but the SER was not significantly reduced. CONCLUSIONS:Topical 2% niacinamide may be effective in lowering the SER in Japanese individuals and CSL in Caucasian individuals.
RCT Entities:
BACKGROUND: The presence of sebum on the face is responsible for both facial shine and the formation of comedonal and inflammatory acne lesions. Sebum control is a goal of many OTC skin care products; however, most currently available products function by absorbing sebum from the face rather than modulating its production. OBJECTIVE: To demonstrate the effect of topical 2% niacinamide on sebum excretion rates and casual sebum production in Oriental and Caucasian populations. METHODS: Separate clinical trials were conducted in both Japan and the USA to evaluate the effect of topical 2% niacinamide in different ethnic groups. A total of 100 Japanese subjects were enrolled in a double-blind, placebo-controlled comparison between two independent balanced groups. Fifty subjects applied the 2% niacinamide moisturizer to the face for 4 weeks and 50 subjects used a placebo moisturizer for 4 weeks, with sebum excretion rate (SER) measurements taken at baseline, week 2, and week 4. In addition, 30 Caucasian subjects were enrolled in a randomized split-face study for 6 weeks with SER and casual sebum levels (CSL) measured at baseline, week 3, and week 6. RESULTS: The results of the Japanese study demonstrated that the SER of the two groups was not significantly different at baseline, but the 2% niacinamide treated group demonstrated significantly lowered SER after 2 and 4 weeks of application. The results were somewhat different in the Caucasian study. After 6 weeks of treatment, the CSL was significantly reduced, but the SER was not significantly reduced. CONCLUSIONS: Topical 2% niacinamide may be effective in lowering the SER in Japanese individuals and CSL in Caucasian individuals.
Authors: Arnold Markovics; Kinga Fanni Tóth; Katalin Eszter Sós; József Magi; Adrienn Gyöngyösi; Zoltán Benyó; Christos C Zouboulis; Tamás Bíró; Attila Oláh Journal: J Cell Mol Med Date: 2019-07-05 Impact factor: 5.310