Last updated: 11/07/2018 12:30:04
A Safety Study to Investigate the Skin Irritancy Potential of Diclofenac-Menthol Gel
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Cumulative Skin Irritation Study Investigating the Skin Irritancy Potential of MFC51123 Diclofenac-Menthol Gel
Trial description: This research study is being conducted to investigate the skin irritancy potential of a new medication which contains two active ingredients (diclofenac and menthol) together in a gel formulation and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, sprains and strains.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Treatment mean cumulative irritation score
Timeframe: Day 21
Adverse event assessment
Timeframe: 21 days + 5 days follow-up
Secondary outcomes:
Not applicable
Interventions:
Drug: 1% Diclofenac Sodium
Drug: 3% Menthol
Drug: 0.09% Menthol
Drug: 0.2% Sodium Lauryl Sulfate
Drug: 0.9% Saline
Enrollment:
36
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)
June 2014 to July 2014
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Male/female volunteer ≥18 years
- No systemic/dermatologic disorder
- Visible skin disease at the site of application that might interfere with skin assessments
- Allergy or hypersensitivity to NSAIDs or menthol or any of the excipients in the test product
Inclusion and exclusion criteria
Inclusion criteria:
- Male/female volunteer ≥18 years
- No systemic/dermatologic disorder
Exclusion criteria:
- Visible skin disease at the site of application that might interfere with skin assessments
- Allergy or hypersensitivity to NSAIDs or menthol or any of the excipients in the test product
- History of physical or psychiatric illness, or medical disorder
- Recent history of alcohol or drug abuse
- Pregnant or lactating females
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
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
2014-01-07
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
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Additional information
Results for the study 202187 can be found on the GSK Clinical Study Register.
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