Lactoferrin + Vitamin E + Zinc for Hormonal Acne

United Laboratories136 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

136

Conditions

Hormonal Acne

Interventions

Eligibility

Sex: FEMALEMin age: 22 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Females aged 22-50. 2. At least 3 inflammatory acne lesions, mostly found on (but not limited to) the lower face 3. Not responsive to conventional treatment 4. Clinical diagnosis of mild to moderate acne according to Lehmann et. al. Exclusion Criteria: 1. Females who are pregnant (confirmed by a pregnancy test), breast- feeding, or planning a 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-morbidities such 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)

Outcomes

Primary Outcomes

Mean percentage change in inflammatory acne lesions at 2, 4, 6, 8, 10, and 12 weeks compared to baseline, in the treatment versus placebo groups

Time frame: 12 weeks

Secondary Outcomes

Percentage change in inflammatory acne lesion counts at 14, 16, 18, 20, 22, and 24 weeks compared to baseline

Time frame: 24 weeks

Mean percent change in the AFAST scores at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 weeks compared to baseline, in the treatment versus placebo groups