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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Double Blind and Placebo-controlled Pilot Study to Evaluate the Effect of a Probiotic Mixture in Acne Vulgaris

Conditions
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Acne, Acne Vulgaris

Intervention / Treatment
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* Dietary Supplement: Probiotic Bths-003
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo with maltodextrin base.<br>|
| Experimental: Probiotic<br> | Dietary Supplement: Probiotic Bths-003<br>* Probiotic with maltodextrin as a carrier.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AGSS (Acne Global Severity Scale) index score | Score between 0 and 5: 0 = Clean = Normal and clear skin without evidence of acne = Almost clean = There are some non-inflammatory lesions, with uncommon and non-inflamed papules = Mild = few inflammatory lesions (no nodule-cystic lesions) = Moderate = Noninflammatory lesions predominate, but multiple inflammatory lesions appear (nodule-cystic lesions may be present) = Severe = Inflammatory lesions predominate (nodule-cystic lesions may be present) = Very severe = Highly inflammatory lesions predominate (several nodule-cystic lesions) | 0, 6 and 12-week | 
| Number of acne lesions | Number of non-inflammatory, inflammatory and total acne lesions. | 0, 6 and 12-week | 
| Patient subjective evaluation | Min score (Best) = 6 Max score (Worst) = 30 | 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. | 12-week | 
| Treatment safety assessed by number of adverse events | Number of adverse events that occur during the treatment period. | 12-week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic