Lactoferrin + Vitamin E + Zinc for Hormonal Acne

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05151055

Enrollment

136

Registered

2021-12-09

Start date

2020-03-02

Completion date

2022-09-30

Last updated

2021-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormonal Acne

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.

Interventions

DIETARY_SUPPLEMENTLactezin

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

DIETARY_SUPPLEMENTPlacebo

starch

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

22 Years to 50 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Philippines

Contacts

Primary ContactJuliene Lim, Ph.D.

jgco@unilab.com.ph63288581000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026