Efficacy and tolerability of oral lactoferrin supplementation in mild to moderate acne vulgaris: an exploratory study

Abstract

Objective:

Lactoferrin, an innate defense iron-binding protein, possesses antimicrobial and anti-inflammatory activities. Beneficial systemic effects on inflammatory diseases have been proposed. The aim of the present study was to explore the efficacy and tolerability of oral bovine lactoferrin supplementation in subjects with mild to moderate facial acne vulgaris.

Methods:

In this open-label, single-arm study, 43 adolescents and young adults were enrolled to take a chewable tablet formulation of bovine lactoferrin twice daily for 8 weeks. The primary efficacy endpoint was the improvement in acne lesion counts compared with baseline. Tolerability was evaluated on the basis of adverse event frequencies.

Results:

Thirty-nine subjects, aged 17.5 ± 3.8 years, completed the study per protocol. At the end of the study (week 8), a mean reduction in inflammatory lesion count of 20.2% (−2.2 ± 7.0, p = 0.054), in non-inflammatory lesion count of 23.5% (−6.2 ± 9.8, p < 0.001), and in total lesion count of 22.5% (−8.4 ± 13.1, p < 0.001) was observed as compared with baseline. At study conclusion, 76.9% (30 of 39) of subjects showed a reduction in total lesion count. The results for inflammatory acne lesions were variable over the study course. None of the subjects experienced a lactoferrin-related adverse event during the trial.

Conclusion:

Despite the limitations of an uncontrolled, open-label study, the results from this study indicate that lactoferrin in mild to moderate acne vulgaris is well tolerated and may lead to an overall improvement in acne lesion counts in the majority of affected adolescents and young adults when administered as a dietary supplement on a twice daily regimen. Further randomized, placebo-controlled trials of longer duration appear warranted.

Key words::

• Acne vulgaris – Dietary supplement – Efficacy – Lactoferrin – Tolerability

Transparency

Declaration of funding

This study was supported by Mepha LLC, Aesch, Switzerland.

Declaration of financial/other relationships

S.T., A.F. and V.B. have disclosed that they are full-time employees of Mepha LLC. E.A.M. and W.K. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgements

The authors have disclosed that they had no outside editorial assistance in preparing this manuscript. The study and its statistical analysis were carried out by the Contract Research Organization proDERM Institute for Applied Dermatological Research, Schenefeld/Hamburg, Germany.

The chewable tablets, rich in lactoferrin, are approved as food supplement by the Swiss Bundesamt für Gesundheit (BAG) and are marketed in Switzerland by Biotan Ltd under the trademark Dermaplus.