A randomized, double‐blind, placebo‐controlled trial to determine the efficacy and safety of lactoferrin with vitamin E and zinc as an oral therapy for mild to moderate acne vulgaris

Abstract

Lactoferrin is an iron-binding milk-derived protein that has shown antibacterial and anti-inflammatory effects in vitro and in vivo. The objective of this study was to determine the efficacy and safety of lactoferrin, combined with vitamin E and zinc, for mild to moderate acne vulgaris. In this randomized, double-blind, placebo-controlled trial, 168 subjects aged 13-40 years old were randomly assigned to take either a capsule formulation containing lactoferrin with vitamin E and zinc or placebo twice a day for 3 months. The primary outcome measure was a reduction in the number of acne lesions compared to placebo. A total of 164 subjects completed the study per protocol. The lactoferrin group (n = 82) showed a significant median percent reduction in total lesions as early as 2 weeks (14.5%, P = 0.0120), with the maximum reduction occurring at week 10 (28.5%, P < 0.0001) compared to placebo group (n = 82). Maximum reduction in comedones (32.5%, P < 0.0001) and inflammatory lesions (44%, P < 0.0001) was also seen at week 10 compared to placebo. Sebum scores were improved by week 12. No adverse events were observed during the trial. A twice daily regimen of lactoferrin with vitamin E and zinc significantly reduced acne lesions in people with mild to moderate acne vulgaris.

<p>Effects of Lactoferrin on Subjective Skin Conditions in Winter: A Preliminary, Randomized, Double-Blinded, Placebo-Controlled Trial</p>

“…In the analysis of female subjects, changes in the scores of moisture showed significant trend, and were significantly greater in the 200 mg and 600 mg groups, and changes in the scores of texture were also significantly greater in the 600 mg group than in the placebo group. In a previous trial, the effects of LF on acne vulgaris were more clearly observed in women, and an association with the menstrual cycle was suggested 2. This may also be relevant to the results in the present trial.…”

“…In previous clinical trials, the effects of LF on skin illnesses were reported;2,7,9,12,13,16 however, this is the first report suggesting the positive effects of LF on skin conditions in health subjects.…”

“…LF derived from bovine milk has been used to fortify food products and skin care products 14. In previous clinical trials, LF has been shown to improve dermatosis such as tinea pedis,16 acne vulgaris,2,7,9 plaque psoriasis,12 and atopic dermatitis 13. Therefore, intake of LF may be good for skin health.…”

Influence of lactoferrin on Propionibacterium acnes ‐induced inflammation in vitro and in vivo

“…In summary, Mueller 4 and Han 14 showed lactoferrin can significantly reduced acne lesions in people with mild to moderate acne vulgaris. However, the exact anti‐inflammatory mechanism of LF in inflammatory skin diseases remains unclear.…”

Zinc‐containing compounds for personal care applications

“…The efficacy of oral intake of capsule formulations containing lactoferrin, zinc and vitamin E has been confirmed for mild‐to‐moderate acne vulgaris .…”