Back to results"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."
Primary Purpose
Acne Vulgaris
Status
Active
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule
Topical Adapalene, Benzoyl Peroxide Gel
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria: Patients with mild to moderate level of Acne Vulgaris Exclusion Criteria: Pregnancy
Sites / Locations
- TDC PE "Asklepiy"
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Topical Adapalene, Benzoyl Peroxide Gel
Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule
Topical Adapalene,Benzoyl Peroxide Gel,Oral Lactobacillus Rhamnosus,D-chiro-inositol,Inulin Capsule
Arm Description
Outcomes
Primary Outcome Measures
GAGS (Global Acne Grading System)
The primary end point of the study is the intensity of acne manifestations according to the GAGS scale
Secondary Outcome Measures
IGA (Investigator Global Assessment)
The secondary end point of the study is the intensity of acne manifestations according to the IGA scale
Full Information
NCT ID
NCT05855629
First Posted
May 4, 2023
Last Updated
May 4, 2023
Sponsor
Treatment and Diagnostic Center of Private Enterprise "Asklepiy"
Collaborators
delta medical promotions ag
1. Study Identification
Unique Protocol Identification Number
NCT05855629
Brief 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."
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."
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 18, 2022 (Actual)
Primary Completion Date
June 12, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Treatment and Diagnostic Center of Private Enterprise "Asklepiy"
Collaborators
delta medical promotions ag
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical Adapalene, Benzoyl Peroxide Gel
Arm Type
Other
Arm Title
Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule
Arm Type
Other
Arm Title
Topical Adapalene,Benzoyl Peroxide Gel,Oral Lactobacillus Rhamnosus,D-chiro-inositol,Inulin Capsule
Arm Type
Other
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule
Intervention Description
Lactobacillus Rhamnosus 1,5 х 10*9, Inulin 25mg, D-chiro-inositol 250mg
Intervention Type
Drug
Intervention Name(s)
Topical Adapalene, Benzoyl Peroxide Gel
Intervention Description
Adapalene 1mg/g, Benzoyl Peroxide 25mg/ml
Primary Outcome Measure Information:
Title
GAGS (Global Acne Grading System)
Description
The primary end point of the study is the intensity of acne manifestations according to the GAGS scale
Time Frame
180 days
Secondary Outcome Measure Information:
Title
IGA (Investigator Global Assessment)
Description
The secondary end point of the study is the intensity of acne manifestations according to the IGA scale
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with mild to moderate level of Acne Vulgaris
Exclusion Criteria:
Pregnancy
Facility Information:
Facility Name
TDC PE "Asklepiy"
City
Uzhhorod
State/Province
Zakarpattia
ZIP/Postal Code
88000
Country
Ukraine
12. IPD Sharing Statement
Learn more about this 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."
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