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 Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Dietary Supplement: Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule
* Drug: Topical Adapalene, Benzoyl Peroxide Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with mild to moderate level of Acne Vulgaris Exclusion Criteria: Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 27 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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