Lactoferrin + Vitamin E + Zinc for Hormonal Acne

NCT05151055 | Unknown Phase 2

• 1 other identifier: RD2019-01
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Hormonal Acne

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  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

  24 weeks

Study Arms (2)

Lactezin

EXPERIMENTAL

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

Dietary Supplement: Lactezin

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Lactezin DIETARY_SUPPLEMENT

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

Lactezin

Placebo DIETARY_SUPPLEMENT

starch

Placebo

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Females who are pregnant (confirmed by a pregnancy test), breast- feeding, or planning a pregnancy.
• Post-menopausal women
• Current or recent (within 3 months) use of any topical or oral anti- acne products,
• Hormonal contraceptive intake in the preceding six months
• A cancer diagnosis within the past 5 years
• History of hypersensitivity to any component of the test product.
• 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)

Sponsors & Collaborators

• United Laboratories: lead

Study Sites (1)

Clinical Trial Management and Testing Associates, Inc.

City of Muntinlupa, Philippines

RECRUITING

Central Study Contacts

Juliene Lim, Ph.D.

CONTACT

63288581000; jgco@unilab.com.ph

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2021
• First Posted: December 9, 2021
• Study Start: March 2, 2020
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)