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Lactoferrin + Vitamin E + Zinc for Hormonal Acne

NCT05151055 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2021-12-09

No results posted yet for this study

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

DIETARY_SUPPLEMENT

Lactezin

100 mg lactoferrin, 11 IU vitamin E (as alpha tocopherol), and 5 mg zinc (as zinc gluconate)

DIETARY_SUPPLEMENT

Placebo

starch

Sponsors & Collaborators

  • United Laboratories

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2022-06-30
Completion
2022-09-30

Countries

  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05151055 on ClinicalTrials.gov