NCT05151055

Lactoferrin + Vitamin E + Zinc for Hormonal Acne

A Randomized, Double-Blind, Placebo-Controlled Trial To Determine The Safety and Efficacy of Lactoferrin With Vitamin E and Zinc as an Oral Therapy for Mild to Moderate Hormonal Acne in Adult Women

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: United Laboratories · Industry
• Sex: Female
• Age: 22 Years – 50 Years
• Healthy volunteers: Accepted

Summary

We previously showed that twice daily intake of a combination of 100 mg lactoferrin, 11 IU vitamin E, and 5 mg zinc significantly reduced both inflammatory and non-inflammatory acne lesions compared to placebo control. In that study, females showed an overall better response compared to males in terms of total lesions. We speculated that the gender effect may be due to mitigation of the pre- menstrual flare-ups women have that lead to recurring acne, making them have a better response. The objectives of this study are: 1.) to characterize the efficacy and safety of 100 mg lactoferrin + 11 IU vitamin E + 5 mg zinc in the adult female population who suffer from hormonal acne, 2.) to determine whether the anti-acne effect is maintained after treatment stops.

Conditions

• Hormonal Acne

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactezin	100 mg lactoferrin, 11 IU vitamin E (as alpha tocopherol), and 5 mg zinc (as zinc gluconate)
DIETARY_SUPPLEMENT	Placebo	starch

Timeline

• Start date: 2020-03-02
• Primary completion: 2022-06-01
• Completion: 2022-09-01
• First posted: 2021-12-09
• Last updated: 2021-12-09

Locations

1 site across 1 country: Philippines