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NCT05855629 Clinical Trial

"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."

Acne Vulgaris Clinical Trial

Official title:
"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."

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05855629
Other study ID # EDA1370
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 18, 2022
Est. completion date July 30, 2023

Study information
Verified date May 2023
Source Treatment and Diagnostic Center of Private Enterprise "Asklepiy"
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 59
Est. completion date July 30, 2023
Est. primary completion date June 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 27 Years
Eligibility Inclusion Criteria: - Patients with mild to moderate level of Acne Vulgaris Exclusion Criteria: - Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule
Lactobacillus Rhamnosus 1,5 ? 10*9, Inulin 25mg, D-chiro-inositol 250mg
Drug:
• Topical Adapalene, Benzoyl Peroxide Gel
Adapalene 1mg/g, Benzoyl Peroxide 25mg/ml

Locations
Country Name City State
Ukraine TDC PE "Asklepiy" Uzhhorod Zakarpattia

Sponsors (2)
Lead Sponsor Collaborator
Treatment and Diagnostic Center of Private Enterprise "Asklepiy" delta medical promotions ag

Country where clinical trial is conducted

Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary GAGS (Global Acne Grading System) The primary end point of the study is the intensity of acne manifestations according to the GAGS scale 180 days
Secondary IGA (Investigator Global Assessment) The secondary end point of the study is the intensity of acne manifestations according to the IGA scale 180 days
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