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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02169154
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : June 29, 2017
Information provided by (Responsible Party):

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).

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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

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02169154

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United States, New Jersey
TKL Research Inc
Paramus, New Jersey, United States, 07652
Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline Identifier: NCT02169154    
Other Study ID Numbers: 202187
RH02170 ( Other Identifier: GSK )
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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
Dermatologic Agents