Clinical TrialID 6923

The Efficacy of an Oral Probiotic Associated With a Fixed Combination of Benzoyl Peroxide and Adapalene in the Treatment of Acne

NCT05216289

Acne Vulgaris

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Record Fields

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Clinical Trial Id
6923
Evidence Id
6923
Core Evidence Id
6923
Source Clinical Trial Id
6915
Herb2 Clinical Trial Id
HBCT006915
Nct Id
NCT05216289
Title
The Efficacy of an Oral Probiotic Associated With a Fixed Combination of Benzoyl Peroxide and Adapalene in the Treatment of Acne
Status
Completed
Phase
Phase 4
Study Result
No
Study Condition
Acne Vulgaris
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Intervention
DIETARY_SUPPLEMENT: Probiac|OTHER: Placebo
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Triple
Intervention Purpose
Treatment
Gender
All
Age
Child, Adult
Enrollment
400
Outcome Measure
Investigator Global Assessment (IGA), patients were clinically evaluated and the results in relation to the Investigator Global Assessment (IGA), day 30|Investigator Global Assessment (IGA), patients were clinically evaluated and the results in relation to the Investigator Global Assessment (IGA), day 60|Investigator Global Assessment (IGA), patients were clinically evaluated and the results in relation to the Investigator Global Assessment (IGA), day 90|Investigator Global Assessment (IGA), patients were clinically evaluated and the results in relation to the Investigator Global Assessment (IGA), day 120|Investigator Global Assessment (IGA), patients were clinically evaluated and the results in relation to the Investigator Global Assessment (IGA), day 150|Investigator Global Assessment (IGA), patients were clinically evaluated and the results in relation to the Investigator Global Assessment (IGA), day 180
Sponsor Collaborator
Federal University of São Paulo|Medcin Instituto da Pele Ltda
Funded By
OTHER
Location
Medcin Instituto da Pele Ltda, Sao Paulo, SP, 06023-000, Brazil
Other Id
Probiac
Start Date
2018-04-01
Primary Completion Date
2021-04-01
Completion Date
2021-04-01
First Posted
2022-01-31
Results First Posted
Last Update Posted
2022-01-31
Study Document
Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/89/NCT05216289/SAP_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/89/NCT05216289/ICF_001.pdf
Study Url
https://clinicaltrials.gov/study/NCT05216289
Title Cn
Title En
The Efficacy of an Oral Probiotic Associated With a Fixed Combination of Benzoyl Peroxide and Adapalene in the Treatment of Acne
Bilingual Status
semi_complete