Lactoferrin + Vitamin E + Zinc for Hormonal Acne

United Laboratories

Status and phase: Unknown; Phase 2

Conditions: Hormonal Acne

Treatments: Dietary Supplement: Lactezin; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05151055

RD2019-01

Details and patient eligibility

About

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.

Enrollment: 136 estimated patients

Sex: Female

Ages: 22 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 2 patient groups, including a placebo group

Lactezin

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lactezin

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo