Lactoferrin + Vitamin E + Zinc for Hormonal Acne

NCT ID: NCT05151055

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-02

Study Completion Date

2022-09-30

Brief Summary

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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

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Conditions

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Hormonal Acne

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lactezin

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

Group Type EXPERIMENTAL

Lactezin

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

starch

Interventions

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Lactezin

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

starch

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

22 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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United Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Trial Management and Testing Associates, Inc.

City of Muntinlupa, , Philippines

Site Status RECRUITING

Countries

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Philippines

Central Contacts

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Juliene Lim, Ph.D.

Role: CONTACT

Phone: 63288581000

Email: [email protected]

Facility Contacts

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Gertrude Chan, M.D.

Role: primary

Other Identifiers

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RD2019-01

Identifier Type: -

Identifier Source: org_study_id