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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Bths-08 | Experimental | a capsule containing the probiotic blend (nutritional complement) |
|
| Placebo | Placebo Comparator | a capsule containing placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Bths-08 | Dietary Supplement | A capsule containing the probiotic blend (dietary supplement), administered once daily for 12 weeks |
|
| 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
Patients who improve in at least one category of the scale are considered as responders to treatment. | 0 and 12-week |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vicente Navarro-Lopez, PhD; MD | Universidad Católica San Antonio de Murcia (UCAM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Católica San Antonio de Murcia | Guadalupe | Murcia | 30107 | Spain | ||
| Centro Dermatológico Estético de Alicante |
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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 | Dietary Supplement | A capsule containing the placebo (dietary supplement), administered one daily for 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; 1-19 = 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 |
| Alicante |
| 03014 |
| Spain |
| Hospital Universitari Sagrat Cor | Barcelona | Spain |
| Clínica Eguren Dermatología y Estética | Madrid | 28006 | Spain |