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

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: 0.2% Sodium Lauryl Sulfate; Drug: 0.9% Saline; Drug: 1% Diclofenac Sodium; Drug: 3% Menthol; Drug: 0.09% Menthol

• Registration Number: NCT02169154
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

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).

Study Timeline

• Study Start: 2014-06-01
• Study First Submitted: 2014-06-19
• Study First Submitted QC: 2014-06-19
• Study First Posted: 2014-06-23
• Primary Completion: 2014-07-01
• Study Completion: 2014-07-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Male/female volunteer ≥18 years
• No systemic/dermatologic disorder

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diclofenac Sodium/Menthol Gel	3% Menthol	1% diclofenac sodium + 3% menthol
Diclofenac Gel	0.09% Menthol	1% diclofenac sodium + 0.09% menthol
Menthol Gel	3% Menthol	3% menthol
Sodium lauryl sulfate	0.2% Sodium Lauryl Sulfate	0.2% Sodium lauryl sulfate
Saline	0.9% Saline	0.9% saline
Diclofenac Sodium/Menthol Gel	1% Diclofenac Sodium	1% diclofenac sodium + 3% menthol
Voltaren Gel	1% Diclofenac Sodium	1% diclofenac sodium
Diclofenac Gel	1% Diclofenac Sodium	1% diclofenac sodium + 0.09% menthol
Placebo Gel	0.09% Menthol	0.09% menthol

Primary Outcome Measures

Name	Time	Method
Treatment mean cumulative irritation score	Day 21	Cumulative irritation scores will be defined daily as the sum of irritation score and grade number
Adverse event assessment	21 days + 5 days follow-up	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

Trial Locations

Locations (1)

TKL Research Inc; 🇺🇸 Paramus, New Jersey, United States