Clinical Trial to Evaluate the Effect of a Probiotic in Acne
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|ClinicalTrials.gov Identifier: NCT04570319|
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : May 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acne Acne Vulgaris||Dietary Supplement: Probiotic Bths-08 Dietary Supplement: Placebo||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double Blind and Placebo-Controlled Clinical Trial to Evaluate the Effect of a Probiotic in Patients With Acne|
|Actual Study Start Date :||April 29, 2020|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||October 2021|
Experimental: Probiotic Bths-08
a capsule containing the probiotic blend (nutritional complement)
Dietary Supplement: Probiotic Bths-08
A capsule containing the probiotic blend (dietary supplement), administered once daily for 12 weeks
Placebo Comparator: Placebo
a capsule containing placebo comparator
Dietary Supplement: Placebo
A capsule containing the placebo (dietary supplement), administered one daily for 12 weeks
- Change from baseline in the AGSS (Acne Global Severity Scale) index at 12 weeks [ Time Frame: 0 and 12-week ]
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)
- Change from baseline in the GAGS (Global Acne Grading System) index at week 12 [ Time Frame: 0 and 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
- Change from baseline in the number of acne lesions at week 12 [ Time Frame: 0 and 12-week ]Number of non-inflammatory, inflammatory and total acne lesions.
- Change from the baseline in the patient subjective evaluation index at week 12 [ Time Frame: 0 and 12-week ]Min score (Best) = 6 Max score (Worst) = 30
- Use of antibiotic acne treatment [ Time Frame: 12-week ]Days of antibiotic use for the acne treatment, registered by the patient.
- Change in the percentage of patients with presence of Cutibacterium acnes and Staphylococcus aureus in skin microbiome [ Time Frame: 0 and 12-week ]Skin sample and genomic and microbiological analysis.
- Change in the microbiome components on stool samples [ Time Frame: 0 and 12-week ]Stool sample and high-throughput sequencing data analysis.
- Adherence to treatment [ Time Frame: 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 [ Time Frame: 12-week ]Number of adverse events that occur during the treatment period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570319
|Contact: Laura Navarro-Moratallaemail@example.com|
|Universidad Católica San Antonio de Murcia||Recruiting|
|Guadalupe, Murcia, Spain, 30107|
|Contact: Vicente Navarro firstname.lastname@example.org|
|Centro Dermatológico Estético de Alicante||Recruiting|
|Alicante, Spain, 03014|
|Contact: Diego Vela|
|Clínica Eguren Dermatología y Estética||Recruiting|
|Madrid, Spain, 28006|
|Contact: Cristina Eguren|
|Hospital Vithas Nisa 9 de Octubre-Valencia||Withdrawn|
|Valencia, Spain, 46015|
|Principal Investigator:||Vicente Navarro-Lopez, PhD; MD||Universidad Católica San Antonio de Murcia (UCAM)|