Efficacy and the Tolerability of the Sequential Application of Two Marketed Products in Patients With Acne Vulgaris

Study Overview
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Brief Summary
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The aim of this proof of principle study is to evaluate efficacy and safety of the sequential application of two marketed products for the treatment of acne vulgaris, using the Split-Face model

Official Title
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Exploratory Study Evaluating the Efficacy and the Tolerability of the Sequential Application of Two Marketed Products in Patients With Acne Vulgaris, Using a Split-Face Model

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: marketed topical retinoid
* Drug: marketed topical NSAID
* Drug: vehicle gel
* Drug: marketed topical retinoid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects having understood and signed an informed consent form Male or female subjects who are 18 to 35 years (both included) of age presenting acne vulgaris of the face. A minimum of 10 inflammatory lesions (papules and pustules) on the entire face, and a minimum of 20 non-inflammatory lesions (open comedones and closed comedones) on the entire face. Disease severity grade as mild or moderate according to the investigator's global assessment (grade 2 or grade 3) Exclusion Criteria: Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding. Subjects with any acne cysts or more than one nodule per hemiface. Subjects with acne conglobata, acne fulminans, secondary acne (e.g. chloracne, drug-induced acne), or any acne requiring systemic treatment. Subjects with a dark pigmentation of the skin or skin type that may, in any way, confound interpretation of the study results (skin type V or VI on Fitzpatrick scale. Subjects with other facial skin disorders that may interfere with study assessments. Subjects who will use medicated cosmetics and/or soaps (including soaps containing antibacterial agents such as benzoyl peroxide, keratolytic agents such as salicylic acid, skin fresheners/astringents or aftershave products) on the face for the duration of the study. Subjects with a history of actinic keratosis on the face or skin cancer. Use of hormonal oral contraceptives for acne control for less than 6 months prior to the randomisation. Subjects using one of the following systemic medication within 4 weeks before the randomisation and during the study, which could have an effect on the trial disease. systemic corticosteroids, anti-acne drugs, oral retinoids any immunosuppressive drugs. Subjects using systemic NSAIDs (including aspirin) within 1 week before the randomisation and during the study. Subjects using paracetamol within 1 week before the randomisation. Paracetamol will be allowed during the study with a maximum dose of 1g twice daily and for a maximum of 3 consecutive days Subjects using one of the following topical medication within 2 weeks before the randomisation and during the study, which could have an effect on the trial disease: anti-inflammatory drugs (e.g. topical corticosteroids, NSAIDs), anti-acne drugs, topical retinoids, topical antibacterial agents any topical immunosuppressive drugs. Subjects with known or suspected hypersensitivity to component(s) of the investigational products or other nonsteroidal anti- inflammatory drug NSAIDs (e.g., aspirin, diclofenac, ibuprofen, ketoprofen). Subjects with presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting). Subjects with known presence of active peptic ulcer. Subjects with history (during the last 10 years) or known presence of asthma. Subjects with history (during the last 5 years) or known presence of rhinitis or urticaria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Topical retinoid - Placebo<br> | Drug: vehicle gel<br>* once daily application, 4 weeks<br>Drug: marketed topical retinoid<br>* once daily application, 4 weeks<br>|
| Active Comparator: Topical retinoid-NSAID<br> | Drug: marketed topical retinoid<br>* once daily application, 4 weeks<br>Drug: marketed topical NSAID<br>* once daily application, 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in Inflammatory Lesions From Baseline to End of Treatment | Percentage change in inflammatory lesions count from baseline to the end of treatment | Baseline to End of treatment (4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inflammatory Lesions Count | Percentage change in non-inflammatory lesions count from baseline to the end of treatment | Baseline to End of treatment (4 weeks) | 
| Total Lesions Count | Percentage change in total lesions count from baseline to the end of treatment | Baseline to End of treatment (4 weeks) | 
| Percentage Change in Total Lesions Count | Percentage change in total leasions count from baseline to day 8 | Baseline to Day 8 | 
| Percentage Change in Total Lesions Count | Percentage change in total lesions count from baseline to day 15 | Baseline to Day 15 | 
| Percentage Change in Total Lesions Count | Percentage change in total lesions count from baseline to day 22 | Baseline to Day 22 | 
| Investigator Global Assessment (IGA) of Disease Severity | The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe). The outcome was the proportion of success (improvement of two grades of the IGA) from baseline to the end of treatment. Success is defined as improvement of two grades from the baseline assessment. | Baseline to End of treatment (4 weeks) |