Last updated: 11/07/2018 12:29:49
A Safety Study to Investigate the Skin Sensitization Potential of MFC51123
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Safety Study to Investigate the Skin Sensitization Potential of MFC51123
Trial description: 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 purpose:
Other
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Skin irritation
Timeframe: At least 23 days but not more than 30 days for induction and challenge phases combined
Secondary outcomes:
Effects on Superficial Layers of the Skin
Timeframe: At least 23 days but not more than 30 days for induction and challenge phases combined
Response notation
Timeframe: At least 23 days but not more than 30 days for induction and challenge phases combined
Interventions:
Drug: Diclofenac + Menthol Gel
Drug: Diclofenac Only Gel
Drug: Menthol Only Gel
Drug: Placebo Only Gel
Enrollment:
227
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Drug Res (Stuttg) 2017; 67(02): 119-126 DOI: 10.1055/s-0042-118861
Medical condition
Pain
Product
diclofenac, diclofenac/levomenthol, levomenthol
Collaborators
Not applicable
Study date(s)
April 2014 to July 2014
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Healthy men or women participants with 18 years of age or older.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2014-15-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Results for the study 202186 can be found on the GSK Clinical Study Register.
Click hereAccess to clinical trial data by researchers
Visit website