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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactezin | Experimental | 100 mg lactoferrin, 11 IU vitamin E (as alpha tocopherol), and 5 mg zinc (as zinc gluconate) |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactezin | Dietary Supplement | 100 mg lactoferrin, 11 IU vitamin E (as alpha tocopherol), and 5 mg zinc (as zinc gluconate) |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
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,
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juliene Lim, Ph.D. | Contact | 63288581000 | jgco@unilab.com.ph |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Management and Testing Associates, Inc. | Recruiting | City of Muntinlupa | Philippines |
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| Placebo | Dietary Supplement | starch |
|
| 24 weeks |