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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Probiotic | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Bths-003 | Dietary Supplement | Probiotic with maltodextrin as a carrier. |
| |
| 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 |
| 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
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vithas Nisa 9 de Octubre | Valencia | 46015 | Spain |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Placebo |
| Other |
Placebo with maltodextrin base. |
|
| 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 |