Acne, Acne Vulgaris
Conditions
Keywords
Probiotic
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.
Interventions
DIETARY_SUPPLEMENTProbiotic Bths-003
Probiotic with maltodextrin as a carrier.
OTHERPlacebo
Placebo with maltodextrin base.
Sponsors
Bionou Research, S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 30 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Number of acne lesions | 0, 6 and 12-week | Number of non-inflammatory, inflammatory and total acne lesions. |
| Patient subjective evaluation | 0, 6 and 12-week | Min score (Best) = 6 Max score (Worst) = 30 |
| 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. |
| Treatment safety assessed by number of adverse events | 12-week | Number of adverse events that occur during the treatment period. |
Countries
Spain
Outcome results
None listed