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Trial record 13 of 49 for:    Sodium Lauryl Sulfate

RIPT of Ibuprofen Topical Gel

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ClinicalTrials.gov Identifier: NCT01787448
Recruitment Status : Completed
First Posted : February 8, 2013
Last Update Posted : February 28, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This study is being conducted to determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to cause sensitization after repeated topical application to healthy skin of human subjects under controlled conditions.

Condition or disease Intervention/treatment Phase
Pain Drug: Topical gel vehicle Drug: Sodium lauryl sulfate 0.1% Drug: Sodium chloride solution 0.9% (saline) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Repeat-insult Patch Test (Ript) of Ibuprofen 5% Topical Gel in Human Volunteers
Study Start Date : January 2013
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ibuprofen 5% topical gel Drug: Topical gel vehicle
0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application

Experimental: Topical gel vehicle Drug: Topical gel vehicle
0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application

Active Comparator: Sodium lauryl sulfate 0.1% Drug: Sodium lauryl sulfate 0.1%
0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application

Sham Comparator: Sodium chloride solution 0.9% (saline) Drug: Sodium chloride solution 0.9% (saline)
0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application




Primary Outcome Measures :
  1. Dermal sensitization potential [ Time Frame: 24-72 hours after last patch removal ]

Secondary Outcome Measures :
  1. Cumulative Irritancy [ Time Frame: 48-72 hours after each patch application ]
  2. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: During study through 28 days after last product application ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy male or female subjects 18 years of age or older, female subjects of childbearing potential and males are using an acceptable form of birth control, subjects are free of any systemic or dermatologic disorder

Exclusion Criteria:

Have any visible skin disease at the application site, not willing to stop use of systemic or topical analgesics, corticosteroids, or antihistamines, not willing to stop use of sunscreens, creams, or similar products on the back during the study


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01787448


Locations
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United States, New Jersey
Pfizer Investigational Site
Carlstadt, New Jersey, United States, 07652
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01787448     History of Changes
Other Study ID Numbers: B3491007
First Posted: February 8, 2013    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: February 2013
Keywords provided by Pfizer:
repeat insult patch test
Additional relevant MeSH terms:
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Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action