A Safety Study to Investigate the Skin Irritancy Potential of Diclofenac-Menthol Gel

Pain Clinical Trial

Official title:

A Cumulative Skin Irritation Study Investigating the Skin Irritancy Potential of MFC51123 Diclofenac-Menthol Gel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169154
• Other study ID #: 202187
• Secondary ID: RH02170
• Status: Completed
• Phase: Phase 1
• First received: June 19, 2014
• Last updated: June 28, 2017
• Start date: June 1, 2014
• Est. completion date: July 1, 2014

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 1, 2014
• Est. primary completion date: July 1, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 1% Diclofenac Sodium
1% diclofenac sodium
• 3% Menthol
3% Menthol
• 0.09% Menthol
0.09% Menthol
• 0.2% Sodium Lauryl Sulfate
0.2% Sodium Lauryl Sulfate
• 0.9% Saline
0.9% Saline

Locations

Country	Name	City	State
United States	TKL Research Inc	Paramus	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment mean cumulative irritation score	Cumulative irritation scores will be defined daily as the sum of irritation score and grade number	Day 21
Primary	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

External Links

•   Results for the study 202187 can be found on the GSK Clinical Study Register.