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A Safety Study to Investigate the Skin Sensitization Potential of MFC51123

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ClinicalTrials.gov Identifier: NCT02192203
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Diclofenac + Menthol Gel Drug: Diclofenac Only Gel Drug: Menthol Only Gel Drug: Placebo Only Gel Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Safety Study to Investigate the Skin Sensitization Potential of MFC51123
Actual Study Start Date : April 1, 2014
Actual Primary Completion Date : July 15, 2014
Actual Study Completion Date : July 15, 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Skin irritation [ Time Frame: At least 23 days but not more than 30 days for induction and challenge phases combined ]
    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.


Secondary Outcome Measures :
  1. Effects on Superficial Layers of the Skin [ Time Frame: At least 23 days but not more than 30 days for induction and challenge phases combined ]
    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

  2. Response notation [ Time Frame: At least 23 days but not more than 30 days for induction and challenge phases combined ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192203


Locations
United States, New Jersey
TKL Research Inc
Paramus, New Jersey, United States, 07652
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02192203     History of Changes
Other Study ID Numbers: 202186
RH02169 ( Other Identifier: GSK )
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Diclofenac
Menthol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents