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Local Skin Safety Study of a Topical Pain Relief Spray Containing a Combination of Diclofenac, Methyl Salicylate, and Menthol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02400320
Recruitment Status : Withdrawn
First Posted : March 27, 2015
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE January 29, 2015
First Posted Date  ICMJE March 27, 2015
Last Update Posted Date September 12, 2017
Estimated Study Start Date  ICMJE March 1, 2016
Estimated Primary Completion Date June 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
Mean cumulative irritation score [ Time Frame: 7 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Local Skin Safety Study of a Topical Pain Relief Spray Containing a Combination of Diclofenac, Methyl Salicylate, and Menthol
Official Title  ICMJE Cumulative Skin Irritation Study Evaluating the Skin Irritancy Potential of Topical Analgesic Vovilup Spray Containing a Combination of Diclofenac, Menthol, Methyl Salicylate and Linseed Oil and Comparing it With a Marketed Formulation - Iodex Ultragel
Brief Summary The purpose of this study is to determine local skin safety of a topical analgesic spray containing a combination of diclofenac, methyl salicylate, menthol and compare it with a topical analgesic gel containing a combination of diclofenac, methyl salicylate, and menthol.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Skin Irritation
Intervention  ICMJE
  • Drug: Topical Spray
    Topical spray containing Diclofenac 1.16%, Linseed Oil 3%, Menthol 5%, Methyl salicylate 10%.
  • Drug: Topical Gel
    Topical gel containing Diclofenac 1.16%, Menthol 5%, Methyl salicylate 10%
  • Other: Saline
    Saline
Study Arms  ICMJE
  • Active Comparator: Topical Spray
    Topical spray containing Diclofenac 1.16%, Linseed Oil 3%, Menthol 5%, Methyl salicylate 10%.
    Intervention: Drug: Topical Spray
  • Experimental: Topical Gel
    Topical gel containing Diclofenac 1.16%, Menthol 5%, Methyl salicylate 10%
    Intervention: Drug: Topical Gel
  • Saline
    Saline
    Intervention: Other: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 12, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2015)
42
Estimated Study Completion Date  ICMJE June 30, 2016
Estimated Primary Completion Date June 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Healthy male or female volunteers aged at least 18 years.
  2. Good general, physical and mental health in the opinion of the investigator or medically qualified designee:

    • No clinically significant and relevant abnormalities in medical history or upon physical examination.
    • Absence of any condition that could affect the volunteer's safety or well being or their ability to understand and follow study procedures and requirements.
  3. Healthy volunteers who do not have excessive hair on the volar aspect of the forearm(s).
  4. Healthy volunteers should understand and be willing to fully comply with all study procedures and restrictions.
  5. Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
  6. Females of childbearing potential, using an effective contraceptive method for at least one month before the beginning of the study, and willing to use throughout the study

Exclusion Criteria

  1. Volunteers having recent history (within one year) of alcohol or other substance abuse as determined by medical history.
  2. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
  3. Previous participation in similar study with similar products.
  4. Volunteer has any visible skin disease at the site of application that, in the opinion of the investigator, will interfere with the skin assessments.
  5. Volunteer has current or relevant previous history of serious, severe or unstable physical or psychiatric illness, or medical disorders, such as current or previous history of hepatic or renal diseases (impairment) or peptic ulcer as determined by medical history.
  6. Volunteer has a history of hypersensitivity (e.g. asthma, bronchospasm, rhinitis, urticaria, nasal polyps) to aspirin, diclofenac, other non steroidal anti-inflammatory drugs (NSAIDs), menthol or any of the excipients in the test product(s).
  7. Volunteer is receiving systemic or topical NSAIDs, other oral or topical analgesics or antihistamine within 3 days of visit 1, or other medication (such as corticosteroids within 3 weeks of visit 1) which, in the opinion of the investigative personnel, will interfere with the study results.
  8. Female volunteers who are pregnant, planning to become pregnant during the study, or are breast-feeding.
  9. Female volunteers who have positive pregnancy test.
  10. Volunteers who are employees of the sponsor or study site or an immediate family member (e.g. partner, offspring, parents, siblings or sibling's offspring) of such employees.
  11. Any skin disorder at the test site that in the investigator's judgement can affect the readings of the test result
  12. Any concomitant medications that in the investigator's judgement can confound or alter test results or evaluation of adverse events.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02400320
Other Study ID Numbers  ICMJE 202201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party GlaxoSmithKline
Original Responsible Party Same as current
Current Study Sponsor  ICMJE GlaxoSmithKline
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP