A Safety Study to Investigate the Skin Irritancy Potential of Diclofenac-Menthol Gel
A Cumulative Skin Irritation Study Investigating the Skin Irritancy Potential of MFC51123 Diclofenac-Menthol Gel
2 other identifiers
interventional
36
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 pain
Started Jun 2014
Shorter than P25 for phase_1 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 19, 2014
CompletedFirst Posted
Study publicly available on registry
June 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJune 29, 2017
June 1, 2017
1 month
June 19, 2014
June 28, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Treatment mean cumulative irritation score
Cumulative irritation scores will be defined daily as the sum of irritation score and grade number
Day 21
Adverse event assessment
Adverse events will be graded on a three-point scale: 1. Mild-easily tolerated, causing minimal discomfort and not interfering with normal everyday activities; 2. Moderate-sufficiently discomforting to interfere with normal everyday activities; 3. Severe-any event that prevents normal everyday activities
21 days + 5 days follow-up
Study Arms (7)
Diclofenac Sodium/Menthol Gel
EXPERIMENTAL1% diclofenac sodium + 3% menthol
Diclofenac Gel
ACTIVE COMPARATOR1% diclofenac sodium + 0.09% menthol
Menthol Gel
ACTIVE COMPARATOR3% menthol
Placebo Gel
PLACEBO COMPARATOR0.09% menthol
Voltaren Gel
ACTIVE COMPARATOR1% diclofenac sodium
Sodium lauryl sulfate
PLACEBO COMPARATOR0.2% Sodium lauryl sulfate
Saline
PLACEBO COMPARATOR0.9% saline
Interventions
Eligibility Criteria
You may qualify if:
- Male/female volunteer ≥18 years
- No systemic/dermatologic disorder
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
TKL Research Inc
Paramus, New Jersey, 07652, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2014
First Posted
June 23, 2014
Study Start
June 1, 2014
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
June 29, 2017
Record last verified: 2017-06