A Safety Study to Investigate the Skin Sensitization Potential of MFC51123

Safety Study to Investigate the Skin Sensitization Potential of MFC51123

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Diclofenac + Menthol Gel; Drug: Diclofenac Only Gel; Drug: Menthol Only Gel; Drug: Placebo Only Gel

• Study Type: Interventional
• Enrollment (Actual): 227
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Paramus, New Jersey, United States, 07652
      • TKL Research Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diclofenac + Menthol Gel; 1% diclofenac, 3% menthol	Drug: Diclofenac + Menthol Gel; 1% diclofenac, 3% menthol
Active Comparator: Diclofenac Only Gel; 1% diclofenac, 0.09% menthol	Drug: Diclofenac Only Gel; 1% diclofenac, 0.09% menthol
Active Comparator: Menthol Only Gel; 3% menthol	Drug: Menthol Only Gel; 3% menthol
Placebo Comparator: Placebo Only Gel; 0.09% menthol	Drug: Placebo Only Gel; 0.09% menthol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects on Superficial Layers of the Skin	The responses will be assessed using symbol (A-H) and grade (0 -3) scale for each of the four test products: A 0 Slight glazed appearance; C 1 Marked glazing; E 2 Glazing with peeling and cracking; F 3 Glazing with fissures; G 3 Film of dried serous exudate covering all or portion of the patch; H 3 Small petechial erosions and/or scabs	At least 23 days but not more than 30 days for induction and challenge phases combined
Response notation	Notations will be made in place of a score to designate particular circumstances preventing the assignment of a score or in addition to a score to identify damage to the epidermis and/or spreading of a reaction beyond the patch site.S: Spreading of reaction beyond patch study site (i.e., reaction where study material was not in contact with the skin); B: Burning or stinging sensation; P: Papular response >50%; Pv: Papulovesicular response >50%; D: Damage to epidermis: oozing, crusting and/or superficial erosions; I; Itching; X: absent Subject absent; PD: Patch dislodged; NA Not applied; NP: Not patched (due to reaction achieved); N9G: No ninth grading	At least 23 days but not more than 30 days for induction and challenge phases combined

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): July 15, 2014
• Study Completion (Actual): July 15, 2014

Study Registration Dates

• First Submitted: May 15, 2014
• First Submitted That Met QC Criteria: July 14, 2014
• First Posted (Estimate): July 16, 2014

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Dermatologic Agents; Antipruritics; Diclofenac; Menthol
• Other Study ID Numbers: 202186; RH02169 (Other Identifier: GSK)