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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-01

Study Completion Date

2014-07-01

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Diclofenac Sodium/Menthol Gel

1% diclofenac sodium + 3% menthol

Group Type EXPERIMENTAL

1% Diclofenac Sodium

Intervention Type DRUG

1% diclofenac sodium

3% Menthol

Intervention Type DRUG

3% Menthol

Diclofenac Gel

1% diclofenac sodium + 0.09% menthol

Group Type ACTIVE_COMPARATOR

1% Diclofenac Sodium

Intervention Type DRUG

1% diclofenac sodium

0.09% Menthol

Intervention Type DRUG

0.09% Menthol

Menthol Gel

3% menthol

Group Type ACTIVE_COMPARATOR

3% Menthol

Intervention Type DRUG

3% Menthol

Placebo Gel

0.09% menthol

Group Type PLACEBO_COMPARATOR

0.09% Menthol

Intervention Type DRUG

0.09% Menthol

Voltaren Gel

1% diclofenac sodium

Group Type ACTIVE_COMPARATOR

1% Diclofenac Sodium

Intervention Type DRUG

1% diclofenac sodium

Sodium lauryl sulfate

0.2% Sodium lauryl sulfate

Group Type PLACEBO_COMPARATOR

0.2% Sodium Lauryl Sulfate

Intervention Type DRUG

0.2% Sodium Lauryl Sulfate

Saline

0.9% saline

Group Type PLACEBO_COMPARATOR

0.9% Saline

Intervention Type DRUG

0.9% Saline

Interventions

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1% Diclofenac Sodium

1% diclofenac sodium

Intervention Type DRUG

3% Menthol

Intervention Type DRUG

0.09% Menthol

Intervention Type DRUG

0.2% Sodium Lauryl Sulfate

Intervention Type DRUG

0.9% Saline

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes