Lactoferrin + Vitamin E + Zinc for Hormonal Acne

Phase 2

• Conditions: Hormonal Acne
• Interventions: Dietary Supplement: Lactezin; Dietary Supplement: Placebo

• Registration Number: NCT05151055
• Lead Sponsor: United Laboratories

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-02
• Status Verified: 2021-11
• Study First Submitted: 2021-11-28
• Study First Submitted QC: 2021-11-28
• Last Update Submitted: 2021-11-28
• Study First Posted: 2021-12-09
• Last Update Posted: 2021-12-09
• Primary Completion: 2022-06
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 136

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactezin	Lactezin	100 mg lactoferrin, 11 IU vitamin E (as alpha tocopherol), and 5 mg zinc (as zinc gluconate)
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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	12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Trial Management and Testing Associates, Inc.; 🇵🇭 Muntinlupa, Philippines