Pain
Conditions
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.
Detailed description
Approximately 36 healthy subject volunteers will be exposed to seven test products (study treatment gel and six control products) simultaneously for 21 consecutive days. The seven test products will be applied using a 7-channel patch assembly that will be affixed to the infrascapular areas of the back of each subject for approximately 24 hours daily. The subject will return to the clinic to undergo a skin irritation assessment at approximately 24 hours after the time the patch assembly was initially affixed. During the visits, doctors or trained staff members will examine the signs of irritation (if any) of the skin where the test products are applied. The skin irritation assessment will primarily characterize the test products individually in terms of symptomatology using a 7-point categorical scale ranging from 1 (glazing and/or wrinkling) to 7 (erosion and/or vesiculation).
Interventions
DRUG1% Diclofenac Sodium
1% diclofenac sodium
DRUG3% Menthol
3% Menthol
DRUG0.09% Menthol
0.09% Menthol
DRUG0.2% Sodium Lauryl Sulfate
0.2% Sodium Lauryl Sulfate
DRUG0.9% Saline
0.9% Saline
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment mean cumulative irritation score | Day 21 | Cumulative irritation scores will be defined daily as the sum of irritation score and grade number |
| Adverse event assessment | 21 days + 5 days follow-up | 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 |
Countries
United States
Outcome results
None listed