Clinical Trial to Evaluate the Effect of a Probiotic in Acne

Bionou Research

Status: Completed

Conditions: Acne; Acne Vulgaris

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotic Bths-08

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04570319

ACNE.PROBI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 12 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signature of informed consent by the patient (and their legal guardian in case of being under age).
• Age between 12 and 30 years-old.
• AGSS (Acne Global Severity Scale) Score: 2 or higher
• Patients who agree to follow the study's dietary recommendations.

Exclusion criteria

• Contraindication of any of the components of the product under study.
• Topical or systemic use of antifungals and antibiotics in the previous 2 weeks.
• Consumption of probiotics in the previous 2 months.
• Use of systemic retinoids in the previous 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 2 patient groups, including a placebo group

Probiotic Bths-08

Experimental group

Description:

a capsule containing the probiotic blend (nutritional complement)

Treatment:

Dietary Supplement: Probiotic Bths-08

Placebo

Placebo Comparator group

Description:

a capsule containing placebo comparator

Treatment:

Dietary Supplement: Placebo