Back to resultsA Pilot Study to Evaluate the Effect of a Probiotic Mixture in Acne
Primary Purpose
Acne, Acne Vulgaris
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Probiotic Bths-003
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acne focused on measuring Probiotic
Eligibility Criteria
Inclusion Criteria:
- Signature of informed consent by the patient (and their legal guardian in case of being under age).
- Age between 12 and 30 years-old.
- Moderate acne according to the AGSS (Acne Global Severity Scale) and / or GAGS (Global Acne Grading System) scales.
Exclusion Criteria:
- Contraindication of any of the components of the product under study.
- Topical or systemic use of antifungals and antibiotics in the previous 2 weeks.
- Consumption of probiotics in the previous 2 months.
- Use of systemic retinoids in the previous 6 months.
Sites / Locations
- Hospital Vithas Nisa 9 de Octubre
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Probiotic
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
AGSS (Acne Global Severity Scale) index score
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
Number of non-inflammatory, inflammatory and total acne lesions.
Patient subjective evaluation
Min score (Best) = 6 Max score (Worst) = 30
Adherence to treatment
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
Number of adverse events that occur during the treatment period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03878238
Brief Title
A Pilot Study to Evaluate the Effect of a Probiotic Mixture in Acne
Official Title
Randomized, Double Blind and Placebo-controlled Pilot Study to Evaluate the Effect of a Probiotic Mixture in Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 11, 2018 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
May 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bionou Research, S.L.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne, Acne Vulgaris
Keywords
Probiotic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Probiotic
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic Bths-003
Intervention Description
Probiotic with maltodextrin as a carrier.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo with maltodextrin base.
Primary Outcome Measure Information:
Title
Change from baseline in GAGS (Global Acne Grading System) index score at 12 weeks
Description
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
Time Frame
12-week
Secondary Outcome Measure Information:
Title
AGSS (Acne Global Severity Scale) index score
Description
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)
Time Frame
0, 6 and 12-week
Title
Number of acne lesions
Description
Number of non-inflammatory, inflammatory and total acne lesions.
Time Frame
0, 6 and 12-week
Title
Patient subjective evaluation
Description
Min score (Best) = 6 Max score (Worst) = 30
Time Frame
0, 6 and 12-week
Title
Adherence to treatment
Description
Compliance rate (in percentage) calculated as the number of leftover capsules divided by the total number of days between visits.
Time Frame
12-week
Title
Treatment safety assessed by number of adverse events
Description
Number of adverse events that occur during the treatment period.
Time Frame
12-week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signature of informed consent by the patient (and their legal guardian in case of being under age).
Age between 12 and 30 years-old.
Moderate acne according to the AGSS (Acne Global Severity Scale) and / or GAGS (Global Acne Grading System) scales.
Exclusion Criteria:
Contraindication of any of the components of the product under study.
Topical or systemic use of antifungals and antibiotics in the previous 2 weeks.
Consumption of probiotics in the previous 2 months.
Use of systemic retinoids in the previous 6 months.
Facility Information:
Facility Name
Hospital Vithas Nisa 9 de Octubre
City
Valencia
ZIP/Postal Code
46015
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study to Evaluate the Effect of a Probiotic Mixture in Acne
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