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

Not Applicable

Completed

• Conditions: Acne; Acne Vulgaris
• Interventions: Other: Placebo; Dietary Supplement: Probiotic Bths-003

• Registration Number: NCT03878238
• Lead Sponsor: Bionou Research, S.L.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-11
• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-15
• Study First Posted: 2019-03-18
• Primary Completion: 2019-04-15
• Study Completion: 2019-05-29
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Probiotic	Probiotic Bths-003	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in GAGS (Global Acne Grading System) index score at 12 weeks	12-week	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

Secondary Outcome Measures

Name	Time	Method
Number of acne lesions	0, 6 and 12-week	Number of non-inflammatory, inflammatory and total acne lesions.
Adherence to treatment	12-week	Compliance rate (in percentage) calculated as the number of leftover capsules divided by the total number of days between visits.
Patient subjective evaluation	0, 6 and 12-week	Min score (Best) = 6 Max score (Worst) = 30
Treatment safety assessed by number of adverse events	12-week	Number of adverse events that occur during the treatment period.
AGSS (Acne Global Severity Scale) index score	0, 6 and 12-week	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)

Trial Locations

Locations (1)

Hospital Vithas Nisa 9 de Octubre; 🇪🇸 Valencia, Spain