"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."

May 4, 2023 updated by: Yuriy Andrashko, Treatment and Diagnostic Center of Private Enterprise "Asklepiy"
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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
    • Zakarpattia
      • Uzhhorod, Zakarpattia, Ukraine, 88000
        • TDC PE "Asklepiy"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with mild to moderate level of Acne Vulgaris

Exclusion Criteria:

  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Topical Adapalene, Benzoyl Peroxide Gel
Drug: Topical Adapalene, Benzoyl Peroxide Gel
Adapalene 1mg/g, Benzoyl Peroxide 25mg/ml
Other: Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule
Dietary supplement: Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule
Lactobacillus Rhamnosus 1,5 х 10*9, Inulin 25mg, D-chiro-inositol 250mg
Other: Topical Adapalene,Benzoyl Peroxide Gel,Oral Lactobacillus Rhamnosus,D-chiro-inositol,Inulin Capsule
Drug: Topical Adapalene, Benzoyl Peroxide Gel
Adapalene 1mg/g, Benzoyl Peroxide 25mg/ml
Dietary supplement: Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule
Lactobacillus Rhamnosus 1,5 х 10*9, Inulin 25mg, D-chiro-inositol 250mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IGA (Investigator Global Assessment)
Time Frame: 180 days
The secondary end point of the study is the intensity of acne manifestations according to the IGA scale
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Treatment and Diagnostic Center of Private Enterprise "Asklepiy"

Collaborators

delta medical promotions ag

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2022

Primary Completion (Anticipated)

June 12, 2023

Study Completion (Anticipated)

July 30, 2023

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDA1370

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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