Last updated: 11/07/2018 12:30:04

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

GSK study ID
202187
See study documents
Clinicaltrials.gov ID
NCT02169154
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    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)

    Location
    Status
    Contact us
    Contact us
    Location
    TKL Research Inc
    Paramus, NJ, United States, 07652
    Status
    Study Complete
    Contact us

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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

    Participate in clinical trial
    Additional information
    Results for the study 202187 can be found on the GSK Clinical Study Register.
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    Access to clinical trial data by researchers
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