A Pilot Study to Evaluate the Effect of a Probiotic Mixture in Acne
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|ClinicalTrials.gov Identifier: NCT03878238|
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acne Acne Vulgaris||Dietary Supplement: Probiotic Bths-003 Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized, Double Blind and Placebo-controlled Pilot Study to Evaluate the Effect of a Probiotic Mixture in Acne Vulgaris|
|Actual Study Start Date :||July 11, 2018|
|Estimated Primary Completion Date :||April 30, 2019|
|Estimated Study Completion Date :||May 30, 2019|
|Placebo Comparator: Placebo||
Placebo with maltodextrin base.
Dietary Supplement: Probiotic Bths-003
Probiotic with maltodextrin as a carrier.
- Change from baseline in GAGS (Global Acne Grading System) index score at 12 weeks [ Time Frame: 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
- AGSS (Acne Global Severity Scale) index score [ Time Frame: 0, 6 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)
- Number of acne lesions [ Time Frame: 0, 6 and 12-week ]Number of non-inflammatory, inflammatory and total acne lesions.
- Patient subjective evaluation [ Time Frame: 0, 6 and 12-week ]Min score (Best) = 6 Max score (Worst) = 30
- 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): NCT03878238
|Contact: Laura Navarro Moratalla||+34 965 67 66 firstname.lastname@example.org|
|Hospital Vithas Nisa 9 de Octubre||Recruiting|
|Valencia, Spain, 46015|
|Contact: Laura Navarro Moratalla +34 965 67 66 02 email@example.com|