"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."

Not Applicable

Active, not recruiting

• Conditions: Acne Vulgaris
• Interventions: Dietary Supplement: Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule; Drug: Topical Adapalene, Benzoyl Peroxide Gel

• Registration Number: NCT05855629
• Lead Sponsor: Treatment and Diagnostic Center of Private Enterprise "Asklepiy"

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-18
• Status Verified: 2023-05
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-04
• Last Update Submitted: 2023-05-04
• Study First Posted: 2023-05-11
• Last Update Posted: 2023-05-11
• Primary Completion: 2023-06-12
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Patients with mild to moderate level of Acne Vulgaris

Exclusion Criteria

• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
GAGS (Global Acne Grading System)	180 days	The primary end point of the study is the intensity of acne manifestations according to the GAGS scale

Secondary Outcome Measures

Name	Time	Method
IGA (Investigator Global Assessment)	180 days	The secondary end point of the study is the intensity of acne manifestations according to the IGA scale

Trial Locations

Locations (1)

TDC PE "Asklepiy"; 🇺🇦 Uzhhorod, Zakarpattia, Ukraine