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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
81
A capsule containing the probiotic blend (dietary supplement), administered once daily for 12 weeks
A capsule containing the placebo (dietary supplement), administered one daily for 12 weeks
Universidad Católica San Antonio de Murcia
Guadalupe, Murcia, Spain
Centro Dermatológico Estético de Alicante
Alicante, Spain
Hospital Universitari Sagrat Cor
Barcelona, Spain
Clínica Eguren Dermatología y Estética
Madrid, Spain
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 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) Patients who improve in at least one category of the scale are considered as responders to treatment.
Time frame: 0 and 12-week
Change from baseline in the number of acne lesions at week 12
Number of non-inflammatory, inflammatory and total acne lesions.
Time frame: 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.
Time frame: 0 and 12-week
Use of antibiotic acne treatment
Days of antibiotic use for the acne treatment, registered by the patient.
Time frame: 12-week
Change from the baseline in the patient subjective evaluation index at week 12
Min score (Best) = 6 Max score (Worst) = 30
Time frame: 0 and 12-week
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Change in the percentage of patients with presence of Cutibacterium acnes and Staphylococcus aureus in skin microbiome
Skin sample and genomic and microbiological analysis.
Time frame: 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.
Time frame: 12-week
Treatment safety assessed by number of adverse events
Number of adverse events that occur during the treatment period.
Time frame: 12-week