A Safety Study to Investigate the Skin Sensitization Potential of MFC51123

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

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-01

Study Completion Date

2014-07-15

Brief Summary

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This research study is being carried out to determine the possibility that a new medication causes allergic reactions. This new medication contains two active ingredients (diclofenac and menthol) together in a gel and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, and sprains and strains. Approximately 240 participants will have the medication (gel) applied to the skin on a small area of the upper back for approximately 48-hour or 72-hour periods over the course of six weeks. Participation in this research study is voluntary, requiring participants to visit the study clinic on 17 occasions for about 45 minutes each visit. During the visits, doctors or trained staff members will examine the amount of redness, swelling, and other signs of irritation (if any) of the skin where the medication (gel) was applied.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Diclofenac + Menthol Gel

1% diclofenac, 3% menthol

Group Type EXPERIMENTAL

Diclofenac + Menthol Gel

Intervention Type DRUG

1% diclofenac, 3% menthol

Diclofenac Only Gel

1% diclofenac, 0.09% menthol

Group Type ACTIVE_COMPARATOR

Diclofenac Only Gel

Intervention Type DRUG

1% diclofenac, 0.09% menthol

Menthol Only Gel

3% menthol

Group Type ACTIVE_COMPARATOR

Menthol Only Gel

Intervention Type DRUG

3% menthol

Placebo Only Gel

0.09% menthol

Group Type PLACEBO_COMPARATOR

Placebo Only Gel

Intervention Type DRUG

0.09% menthol

Interventions

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Diclofenac + Menthol Gel

1% diclofenac, 3% menthol

Intervention Type DRUG

Diclofenac Only Gel

1% diclofenac, 0.09% menthol

Intervention Type DRUG

Menthol Only Gel

3% menthol

Intervention Type DRUG

Placebo Only Gel

0.09% menthol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy men or women participants with 18 years of age or older.

Exclusion Criteria

* Participants with a history of hypersensitivity, allergy with the use of NSAIDs or menthol or currently receiving systemic or topical NSAIDs within 3 days of visit 1.
* Participants having psoriasis and/or active atopic dermatitis/eczema, and skin infected.
* Lesions, burn or wound in the application site.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes