"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."

• Sponsor: Treatment and Diagnostic Center of Private Enterprise "Asklepiy" (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05855629
• Collaborator: delta medical promotions ag (Other)
• Enrollment: 59
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 17.3
• Patients Per Site Per Month: 3.4

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Dietary Supplement: Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule; Drug: Topical Adapalene, Benzoyl Peroxide Gel	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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."
• Actual Study Start Date: Feb 18, 2022
• Anticipated Primary Completion Date: Jun 12, 2023
• Anticipated Study Completion Date: Jul 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. IGA (Investigator Global Assessment) [180 days]

   The secondary end point of the study is the intensity of acne manifestations according to the IGA scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 27 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients with mild to moderate level of Acne Vulgaris

Exclusion Criteria:

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TDC PE "Asklepiy"	Uzhhorod	Zakarpattia	Ukraine	88000

Sponsors and Collaborators

• Treatment and Diagnostic Center of Private Enterprise "Asklepiy"
• delta medical promotions ag

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuriy Andrashko, Yuriy Andrashko, Treatment and Diagnostic Center of Private Enterprise "Asklepiy"
• ClinicalTrials.gov Identifier: NCT05855629
• Other Study ID Numbers: EDA1370
• First Posted: May 11, 2023
• Last Update Posted: May 11, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acne Vulgaris; Inositol; Adapalene; Benzoyl Peroxide

Study Results

No Results Posted as of May 11, 2023