A Safety Study to Investigate the Skin Irritancy Potential of Diclofenac-Menthol Gel

Study Overview
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Brief Summary
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This research study is being conducted to investigate the skin irritancy potential of a new medication which contains two active ingredients (diclofenac and menthol) together in a gel formulation and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, sprains and strains.

Detailed Description
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Approximately 36 healthy subject volunteers will be exposed to seven test products (study treatment gel and six control products) simultaneously for 21 consecutive days. The seven test products will be applied using a 7-channel patch assembly that will be affixed to the infrascapular areas of the back of each subject for approximately 24 hours daily. The subject will return to the clinic to undergo a skin irritation assessment at approximately 24 hours after the time the patch assembly was initially affixed. During the visits, doctors or trained staff members will examine the signs of irritation (if any) of the skin where the test products are applied. The skin irritation assessment will primarily characterize the test products individually in terms of symptomatology using a 7-point categorical scale ranging from 1 (glazing and/or wrinkling) to 7 (erosion and/or vesiculation).

Official Title
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A Cumulative Skin Irritation Study Investigating the Skin Irritancy Potential of MFC51123 Diclofenac-Menthol Gel

Conditions
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Pain

Intervention / Treatment
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* Drug: 1% Diclofenac Sodium
* Drug: 3% Menthol
* Drug: 0.09% Menthol
* Drug: 0.2% Sodium Lauryl Sulfate
* Drug: 0.9% Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male/female volunteer ≥18 years No systemic/dermatologic disorder Exclusion Criteria: Visible skin disease at the site of application that might interfere with skin assessments Allergy or hypersensitivity to NSAIDs or menthol or any of the excipients in the test product History of physical or psychiatric illness, or medical disorder Recent history of alcohol or drug abuse Pregnant or lactating females

Ages Eligible for Study
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Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac Sodium/Menthol Gel<br>1% diclofenac sodium + 3% menthol | Drug: 1% Diclofenac Sodium<br>* 1% diclofenac sodium<br>Drug: 3% Menthol<br>* 3% Menthol<br>|
| Active Comparator: Diclofenac Gel<br>1% diclofenac sodium + 0.09% menthol | Drug: 1% Diclofenac Sodium<br>* 1% diclofenac sodium<br>Drug: 0.09% Menthol<br>* 0.09% Menthol<br>|
| Active Comparator: Menthol Gel<br>3% menthol | Drug: 3% Menthol<br>* 3% Menthol<br>|
| Placebo Comparator: Placebo Gel<br>0.09% menthol | Drug: 0.09% Menthol<br>* 0.09% Menthol<br>|
| Active Comparator: Voltaren Gel<br>1% diclofenac sodium | Drug: 1% Diclofenac Sodium<br>* 1% diclofenac sodium<br>|
| Placebo Comparator: Sodium lauryl sulfate<br>0.2% Sodium lauryl sulfate | Drug: 0.2% Sodium Lauryl Sulfate<br>* 0.2% Sodium Lauryl Sulfate<br>|
| Placebo Comparator: Saline<br>0.9% saline | Drug: 0.9% Saline<br>* 0.9% Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment mean cumulative irritation score | Cumulative irritation scores will be defined daily as the sum of irritation score and grade number | Day 21 | 
| Adverse event assessment | Adverse events will be graded on a three-point scale: 1. Mild-easily tolerated, causing minimal discomfort and not interfering with normal everyday activities; 2. Moderate-sufficiently discomforting to interfere with normal everyday activities; 3. Severe-any event that prevents normal everyday activities | 21 days + 5 days follow-up |