Trials / Completed
CompletedNCT04570319
Clinical Trial to Evaluate the Effect of a Probiotic in Acne
A Randomized, Double Blind and Placebo-Controlled Clinical Trial to Evaluate the Effect of a Probiotic in Patients With Acne
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 81 (actual)
- Sponsor
- Bionou Research, S.L. · Network
- Sex
- All
- Age
- 12 Years – 30 Years
- Healthy volunteers
- Not accepted
Summary
A 12-week randomized, multicenter and double-blind, placebo-controlled study to evaluate the effect of a probiotic in the clinical and subjective evolution of acne in adolescent and adult patients.
Detailed description
Acne is a chronic inflammatory disease of the skin that affects 85% of younger adults in westernized populations. Acne pathophysiology is multifactorial and may include alterations of the pilosebaceous unit function, skin microbiota, hormone imbalance and gut microbiota. Acne pathology shares features with inflammatory chronic conditions such as metabolic syndrome, obesity or diabetes. Probiotics are live microorganisms that when administered in adequate amounts confer a health benefit for the host. Probiotics are proposed for the treatment of inflammatory chronic conditions, including dermatological diseases as atopic dermatitis and psoriasis. However, the clinical evidence is limited. Therefore, usefulness of probiotics for acne vulgaris treatment must be ascertained in humans. This randomized study aims to evaluate the effect of a probiotic on the treatment and clinical and subjective evolution of acne vulgaris.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Probiotic Bths-08 | A capsule containing the probiotic blend (dietary supplement), administered once daily for 12 weeks |
| DIETARY_SUPPLEMENT | Placebo | A capsule containing the placebo (dietary supplement), administered one daily for 12 weeks |
Timeline
- Start date
- 2020-04-29
- Primary completion
- 2022-07-21
- Completion
- 2022-09-20
- First posted
- 2020-09-30
- Last updated
- 2023-02-16
Locations
4 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT04570319. Inclusion in this directory is not an endorsement.