Clinical Trial to Evaluate the Effect of a Probiotic in Acne

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double Blind and Placebo-Controlled Clinical Trial to Evaluate the Effect of a Probiotic in Patients With Acne

Conditions
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Acne, Acne Vulgaris

Intervention / Treatment
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* Dietary Supplement: Probiotic Bths-08
* Dietary Supplement: 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. 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.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic Bths-08<br>a capsule containing the probiotic blend (nutritional complement) | Dietary Supplement: Probiotic Bths-08<br>* A capsule containing the probiotic blend (dietary supplement), administered once daily for 12 weeks<br>|
| Placebo Comparator: Placebo<br>a capsule containing placebo comparator | Dietary Supplement: Placebo<br>* A capsule containing the placebo (dietary supplement), administered one daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the AGSS (Acne Global Severity Scale) index at 12 weeks | 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) Patients who improve in at least one category of the scale are considered as responders to treatment. | 0 and 12-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the number of acne lesions at week 12 | Number of non-inflammatory, inflammatory and total acne lesions. | 0 and 12-week | 
| Change from baseline in the GAGS (Global Acne Grading System) index at week 12 | 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; 1-19 = Mild; 20-30 = Moderate; 31-38 = Severe; > 38 = Very severe Patients who have a reduction in the score of at least 30% are considered as responders to treatment. | 0 and 12-week | 
| Use of antibiotic acne treatment | Days of antibiotic use for the acne treatment, registered by the patient. | 12-week | 
| Change from the baseline in the patient subjective evaluation index at week 12 | Min score (Best) = 6 Max score (Worst) = 30 | 0 and 12-week | 
| Change in the percentage of patients with presence of Cutibacterium acnes and Staphylococcus aureus in skin microbiome | Skin sample and genomic and microbiological analysis. | 0 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, Acne, Microbiome, Microbiota, Symbiotic