A Safety Study to Investigate the Skin Sensitization Potential of MFC51123

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Menthol Only Gel; Drug: Diclofenac + Menthol Gel; Drug: Diclofenac Only Gel; Drug: Placebo Only Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02192203

202186

RH02169 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 227 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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227 participants in 4 patient groups, including a placebo group

Diclofenac + Menthol Gel

Experimental group

Description:

1% diclofenac, 3% menthol

Treatment:

Drug: Diclofenac + Menthol Gel

Diclofenac Only Gel

Active Comparator group

Description:

1% diclofenac, 0.09% menthol

Treatment:

Drug: Diclofenac Only Gel

Menthol Only Gel

Active Comparator group

Description:

3% menthol

Treatment:

Drug: Menthol Only Gel

Placebo Only Gel

Placebo Comparator group

Description:

0.09% menthol

Treatment:

Drug: Placebo Only Gel