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

Bionou Research, S.L.25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acne Acne Vulgaris

Interventions

Probiotic Bths-003DIETARY_SUPPLEMENT

Probiotic with maltodextrin as a carrier.

PlaceboOTHER

Placebo with maltodextrin base.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 30 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Vithas Nisa 9 de Octubre

Valencia, Spain

Outcomes

Primary Outcomes

Change from baseline in GAGS (Global Acne Grading System) index score at 12 weeks

TOTAL SCORE = Nose S x 1 + Chin S x 1 + Front S x 2 + Right cheek S x 2 + Left cheek S x 2 + Torso S x 3 \[Severity (S): 0 = Absence; 1 = Comedones; 2 = Papules; 3 = Pustules; 4 = Nodules\] SCORE: 0 = Clean; 1-18 = Mild; 19-30 = Moderate; 31-38 = Severe; \> 38 = Very severe

Time frame: 12-week

Secondary Outcomes

AGSS (Acne Global Severity Scale) index score

Score between 0 and 5: 0 = Clean = Normal and clear skin without evidence of acne 1. = Almost clean = There are some non-inflammatory lesions, with uncommon and non-inflamed papules 2. = Mild = few inflammatory lesions (no nodule-cystic lesions) 3. = Moderate = Noninflammatory lesions predominate, but multiple inflammatory lesions appear (nodule-cystic lesions may be present) 4. = Severe = Inflammatory lesions predominate (nodule-cystic lesions may be present) 5. = Very severe = Highly inflammatory lesions predominate (several nodule-cystic lesions)

Time frame: 0, 6 and 12-week

Number of acne lesions

Number of non-inflammatory, inflammatory and total acne lesions.

Time frame: 0, 6 and 12-week

Patient subjective evaluation

Min score (Best) = 6 Max score (Worst) = 30

Time frame: 0, 6 and 12-week

Adherence to treatment

Compliance rate (in percentage) calculated as the number of leftover capsules divided by the total number of days between visits.

Time frame: 12-week

Treatment safety assessed by number of adverse events

Number of adverse events that occur during the treatment period.

Data from ClinicalTrials.gov

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