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

• ClinicalTrials.gov Identifier: NCT02169154
• Recruitment Status: Completed
• First Posted: June 23, 2014
• Last Update Posted: June 29, 2017
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: 1% Diclofenac Sodium; Drug: 3% Menthol; Drug: 0.09% Menthol; Drug: 0.2% Sodium Lauryl Sulfate; Drug: 0.9% Saline	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: A Cumulative Skin Irritation Study Investigating the Skin Irritancy Potential of MFC51123 Diclofenac-Menthol Gel
• Actual Study Start Date: June 1, 2014
• Actual Primary Completion Date: July 1, 2014
• Actual Study Completion Date: July 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Treatment mean cumulative irritation score [ Time Frame: Day 21 ]
   Cumulative irritation scores will be defined daily as the sum of irritation score and grade number
2. Adverse event assessment [ Time Frame: 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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, New Jersey

TKL Research Inc

Paramus, New Jersey, United States, 07652

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02169154
• Other Study ID Numbers: 202187; RH02170 ( Other Identifier: GSK )
• First Posted: June 23, 2014
• Last Update Posted: June 29, 2017
• Last Verified: June 2017

Additional relevant MeSH terms:

Diclofenac; Menthol; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antipruritics; Dermatologic Agents