A Safety Study to Investigate the Skin Sensitization Potential of MFC51123

NCT02192203 | Completed Phase 1

• 2 other identifiers: 202186RH02169
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Skin irritation

  During the Induction Phase, the test article and three controls will be applied to adjacent treatment sites on the infrascapular area of the back for nine 48-hour patch applications. Evaluation of dermal reactions at the application sites will be conducted clinically using a visual scale that rates the degree of erythema, edema, and other signs of cutaneous irritation at nine intervals spaced approximately 48-72 hours apart. Following the Induction Phase participants will return to the clinic to begin the Challenge Phase after 12 to 14- day rest phase. The Challenge Phase will consist of one 48-hour patch application to a naive site on the opposite side of the back. Evaluations of dermal reactions at the application sites will be conducted clinically during the Challenge Phase using the same visual scale at 30 minutes, 24 hours, 48 hours, and 72 hours after removal of the challenge patch.

  At least 23 days but not more than 30 days for induction and challenge phases combined

Secondary Outcomes (2)

• Effects on Superficial Layers of the Skin

  At least 23 days but not more than 30 days for induction and challenge phases combined

• Response notation

  At least 23 days but not more than 30 days for induction and challenge phases combined

Study Arms (4)

Diclofenac + Menthol Gel

EXPERIMENTAL

1% diclofenac, 3% menthol

Drug: Diclofenac + Menthol Gel

Diclofenac Only Gel

ACTIVE COMPARATOR

1% diclofenac, 0.09% menthol

Drug: Diclofenac Only Gel

Menthol Only Gel

ACTIVE COMPARATOR

3% menthol

Drug: Menthol Only Gel

Placebo Only Gel

PLACEBO COMPARATOR

0.09% menthol

Drug: Placebo Only Gel

Interventions

Diclofenac + Menthol Gel DRUG

1% diclofenac, 3% menthol

Diclofenac + Menthol Gel

Diclofenac Only Gel DRUG

1% diclofenac, 0.09% menthol

Diclofenac Only Gel

Menthol Only Gel DRUG

3% menthol

Menthol Only Gel

Placebo Only Gel DRUG

0.09% menthol

Placebo Only Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

TKL Research Inc

Paramus, New Jersey, 07652, United States

Location

Related Links

• Results for the study 202186 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Pain

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: July 16, 2014
• Study Start: April 1, 2014
• Primary Completion: July 15, 2014
• Study Completion: July 15, 2014
• Last Updated: June 28, 2017

Record last verified: 2017-06

Locations

US (1)