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Lactoferrin + Vitamin E + Zinc for Hormonal Acne

Primary Purpose

Hormonal Acne

Status

Recruiting

Phase

Phase 2

Locations

Philippines

Study Type

Interventional

Intervention

Lactezin

Placebo

About this trial

This is an interventional treatment trial for Hormonal Acne

Eligibility Criteria

22 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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)

Sites / Locations

Clinical Trial Management and Testing Associates, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactezin

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT05151055

First Posted

November 28, 2021

Last Updated

November 28, 2021

Sponsor

United Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT05151055

Brief Title

Lactoferrin + Vitamin E + Zinc for Hormonal Acne

Official Title

A Randomized, Double-Blind, Placebo-Controlled Trial To Determine The Safety and Efficacy of Lactoferrin With Vitamin E and Zinc as an Oral Therapy for Mild to Moderate Hormonal Acne in Adult Women

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

March 2, 2020 (Actual)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

United Laboratories

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hormonal Acne

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lactezin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Lactezin

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

starch

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Time Frame

24 weeks

Title

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

Time Frame

24 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Juliene Lim, Ph.D.

Phone

63288581000

jgco@unilab.com.ph

Facility Information:

Facility Name

Clinical Trial Management and Testing Associates, Inc.

City

Muntinlupa

Country

Philippines

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gertrude Chan, M.D.

Phone

(632) 659-3238

clintrialtest@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Lactoferrin + Vitamin E + Zinc for Hormonal Acne

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