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A Safety Study to Investigate the Skin Sensitization Potential of MFC51123

NCT02192203 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2017-06-28

No results posted yet for this study

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

Interventions

DRUG

Diclofenac + Menthol Gel

1% diclofenac, 3% menthol

DRUG

Diclofenac Only Gel

1% diclofenac, 0.09% menthol

DRUG

Menthol Only Gel

3% menthol

DRUG

Placebo Only Gel

0.09% menthol

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-01
Primary Completion
2014-07-15
Completion
2014-07-15

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02192203 on ClinicalTrials.gov