A Pilot Study to Evaluate the Effect of a Probiotic Mixture in Acne

Bionou Research

Status: Completed

Conditions: Acne; Acne Vulgaris

Treatments: Other: Placebo; Dietary Supplement: Probiotic Bths-003

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03878238

ACNE_PROB

Details and patient eligibility

About

A 12-week randomized, double-blind, placebo-controlled pilot study to evaluate the effect of a probiotic blend in the treatment and clinical and subjective evolution of acne vulgaris in adolescent and adult patients between 12 and 30 years.

Enrollment: 25 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.
• Moderate acne according to the AGSS (Acne Global Severity Scale) and / or GAGS (Global Acne Grading System) scales.

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: Double Blind

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25 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Other: Placebo

Probiotic

Experimental group

Treatment:

Dietary Supplement: Probiotic Bths-003