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Clinical Trials/NCT05855629
NCT05855629
Active, not recruiting
Not Applicable

"A Comparative Clinical Evaluation of the Efficacy of Topical Adapalene, Benzoyl Peroxide Gel, Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule, and Their Fixed Combination in Mild to Moderate Acne Vulgaris Patients."

Treatment and Diagnostic Center of Private Enterprise "Asklepiy"1 site in 1 country59 target enrollmentFebruary 18, 2022

Overview

Phase
Not Applicable
Intervention
Topical Adapalene, Benzoyl Peroxide Gel
Conditions
Acne Vulgaris
Sponsor
Treatment and Diagnostic Center of Private Enterprise "Asklepiy"
Enrollment
59
Locations
1
Primary Endpoint
GAGS (Global Acne Grading System)
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

The study aims to conduct a comparative clinical evaluation of the effectiveness of a fixed topical combination of adapalene with benzoyl peroxide in the form of a gel, a fixed combination of Lactobacillus rhamnosus, D-chiro-inositol and inulin in the form of capsules and their combination in patients with acne vulgaris of mild and moderate severity and laboratory lipid analysis profile of sebum, lipid metabolism, and IGF-1 (insulin-like growth factor).

Registry
clinicaltrials.gov
Start Date
February 18, 2022
End Date
July 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Treatment and Diagnostic Center of Private Enterprise "Asklepiy"
Responsible Party
Principal Investigator
Principal Investigator

Yuriy Andrashko

Yuriy Andrashko

Treatment and Diagnostic Center of Private Enterprise "Asklepiy"

Eligibility Criteria

Inclusion Criteria

  • Patients with mild to moderate level of Acne Vulgaris

Exclusion Criteria

  • Pregnancy

Arms & Interventions

Topical Adapalene, Benzoyl Peroxide Gel

Intervention: Topical Adapalene, Benzoyl Peroxide Gel

Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule

Intervention: Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule

Topical Adapalene,Benzoyl Peroxide Gel,Oral Lactobacillus Rhamnosus,D-chiro-inositol,Inulin Capsule

Intervention: Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule

Topical Adapalene,Benzoyl Peroxide Gel,Oral Lactobacillus Rhamnosus,D-chiro-inositol,Inulin Capsule

Intervention: Topical Adapalene, Benzoyl Peroxide Gel

Outcomes

Primary Outcomes

GAGS (Global Acne Grading System)

Time Frame: 180 days

The primary end point of the study is the intensity of acne manifestations according to the GAGS scale

Secondary Outcomes

  • IGA (Investigator Global Assessment)(180 days)

Study Sites (1)

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