Lactoferrin + Vitamin E + Zinc for Hormonal Acne

Last updated: November 28, 2021
Sponsor: United Laboratories
Overall Status: Active - Recruiting

Phase

2

Condition

Rash

Scalp Disorders

Acne

Treatment

N/A

Clinical Study ID

NCT05151055
RD2019-01
  • Ages 22-50
  • Female
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Females aged 22-50.
  2. At least 3 inflammatory acne lesions, mostly found on (but not limited to) the lowerface
  3. Not responsive to conventional treatment
  4. Clinical diagnosis of mild to moderate acne according to Lehmann et. al.

Exclusion

Exclusion Criteria:

  1. Females who are pregnant (confirmed by a pregnancy test), breast- feeding, or planninga pregnancy.
  2. Post-menopausal women
  3. Current or recent (within 3 months) use of any topical or oral anti- acne products,
  4. Hormonal contraceptive intake in the preceding six months
  5. A cancer diagnosis within the past 5 years
  6. History of hypersensitivity to any component of the test product.
  7. Current imuunosuppression. Specifically, these include patients with co-morbiditiessuch as diabetes, HIV, chronic diseases patients requiring maintenance medications,such as vascular disease,
  • hepatitis, eczema, psoriasis, or acute febrile/infectious illnesses
  • (i.e. Dengue, pneumonia, etc)

Study Design

Total Participants: 136
Study Start date:
March 02, 2020
Estimated Completion Date:
September 30, 2022

Connect with a study center

  • Clinical Trial Management and Testing Associates, Inc.

    Muntinlupa,
    Philippines

    Active - Recruiting

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