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NCT02192203 · ClinicalTrials.gov registry record · Phase 1
A Safety Study to Investigate the Skin Sensitization Potential of MFC51123
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 227
- Enrollment target
NCT02192203: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT02192203 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 227 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (278% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02192203, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 227 participants
- Enrollment target
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.
Primary Outcome
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
Interventions
- DRUG Diclofenac + Menthol Gel
- DRUG Diclofenac Only Gel
- DRUG Menthol Only Gel
- DRUG Placebo Only Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 227 participants |
| Start Date | 2014-04-01 |
| Est. Completion | 2014-07-15 |
| Phase | Phase 1 |
What the finished NCT02192203 record still lists
NCT02192203 is an interventional study that assigns participants to a tested intervention. The registered 227 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (278% higher).
The record links to 0 conditions, and to 4 interventions - of which Diclofenac + Menthol Gel is the first listed.
NCT02192203 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02192203 about?
NCT02192203 is a clinical study titled "A 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 ...
What is the current status of trial NCT02192203?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 227 participants. The study started on 2014-04-01. Estimated completion is 2014-07-15.
What interventions are being tested in trial NCT02192203?
The interventions under investigation include: Diclofenac + Menthol Gel (DRUG), Diclofenac Only Gel (DRUG), Menthol Only Gel (DRUG), Placebo Only Gel (DRUG).
Who is sponsoring clinical trial NCT02192203?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02192203's enrollment target sits among peer trials
227 221st of 2000 higher than 1,780 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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