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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: 3% Menthol; Drug: 0.9% Saline; Drug: 1% Diclofenac Sodium; Drug: 0.09% Menthol; Drug: 0.2% Sodium Lauryl Sulfate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02169154

202187

RH02170 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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36 participants in 7 patient groups, including a placebo group

Diclofenac Sodium/Menthol Gel

Experimental group

Description:

1% diclofenac sodium + 3% menthol

Treatment:

Drug: 1% Diclofenac Sodium

Drug: 3% Menthol

Diclofenac Gel

Active Comparator group

Description:

1% diclofenac sodium + 0.09% menthol

Treatment:

Drug: 1% Diclofenac Sodium

Drug: 0.09% Menthol

Menthol Gel

Active Comparator group

Description:

3% menthol

Treatment:

Drug: 3% Menthol

Placebo Gel

Placebo Comparator group

Description:

0.09% menthol

Treatment:

Drug: 0.09% Menthol

Voltaren Gel

Active Comparator group

Description:

1% diclofenac sodium

Treatment:

Drug: 1% Diclofenac Sodium

Sodium lauryl sulfate

Placebo Comparator group

Description:

0.2% Sodium lauryl sulfate

Treatment:

Drug: 0.2% Sodium Lauryl Sulfate

Saline

Placebo Comparator group

Description:

0.9% saline

Treatment:

Drug: 0.9% Saline