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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: 1% Diclofenac Sodium; Drug: 3% Menthol; Drug: 0.09% Menthol; Drug: 0.2% Sodium Lauryl Sulfate; Drug: 0.9% Saline

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Paramus, New Jersey, United States, 07652
      • TKL Research Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

7

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: June 19, 2014
• First Submitted That Met QC Criteria: June 19, 2014
• First Posted (Estimate): June 23, 2014

Study Record Updates

• Last Update Posted (Actual): June 29, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Dermatologic Agents; Antipruritics; Diclofenac; Menthol
• Other Study ID Numbers: 202187; RH02170 (Other Identifier: GSK)