RIPT of Ibuprofen Topical Gel

NCT01787448 | Completed Phase 1

• 1 other identifier: B3491007
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

repeat insult patch test

Outcome Measures

Primary Outcomes (1)

• Dermal sensitization potential

  24-72 hours after last patch removal

Secondary Outcomes (2)

• Cumulative Irritancy

  48-72 hours after each patch application

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  During study through 28 days after last product application

Study Arms (4)

Ibuprofen 5% topical gel

EXPERIMENTAL

Drug: Topical gel vehicle

Topical gel vehicle

EXPERIMENTAL

Drug: Topical gel vehicle

Sodium lauryl sulfate 0.1%

ACTIVE COMPARATOR

Drug: Sodium lauryl sulfate 0.1%

Sodium chloride solution 0.9% (saline)

SHAM COMPARATOR

Drug: Sodium chloride solution 0.9% (saline)

Interventions

Topical gel vehicle DRUG

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

Ibuprofen 5% topical gel

Sodium lauryl sulfate 0.1% DRUG

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

Sodium lauryl sulfate 0.1%

Sodium chloride solution 0.9% (saline) DRUG

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

Sodium chloride solution 0.9% (saline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Carlstadt, New Jersey, 07652, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pain

Interventions

Gels; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: February 8, 2013
• Study Start: January 1, 2013
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 28, 2013

Record last verified: 2013-02

Locations

US (1)