Ibuprofen 5% Topical Gel CIPT

NCT01771822 | Completed Phase 1

• 1 other identifier: B3491004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to cause irritation after repeated topical application to the healthy skin of human subjects under controlled conditions.

Conditions

Pain

Keywords

cumulative irritancy patch test (CIPT)

Outcome Measures

Primary Outcomes (1)

• Assessment of local skin irritation at patch sites

  Daily for 21 days, Days 2 through 22

Secondary Outcomes (1)

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

  Days 1 through 22, + 28 days after last product administration

Study Arms (4)

Ibuprofen 5% topical gel

EXPERIMENTAL

Drug: Ibuprofen 5% topical gel

Topical gel vehicle

EXPERIMENTAL

Drug: Topical gel vehicle

Sodium lauryl sulfate 0.2%

ACTIVE COMPARATOR

Drug: Sodium lauryl sulfate 0.2%

Sodium chloride solution 0.9% (saline)

SHAM COMPARATOR

Drug: Sodium chloride solution 0.9% (saline)

Interventions

Ibuprofen 5% topical gel DRUG

0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions

Ibuprofen 5% topical gel

Topical gel vehicle DRUG

0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions

Topical gel vehicle

Sodium lauryl sulfate 0.2% DRUG

0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions

Sodium lauryl sulfate 0.2%

Sodium chloride solution 0.9% (saline) DRUG

0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions

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 and/or female subjects (to be confirmed by medical history) 18 years of age or older, female subjects of childbearing potential and males who are using an acceptable form of birth control, subjects who are free of any systemic or dermatologic disorder

You may not qualify if:

• Have skin disease at the application site, not willing to stop use of systemic or topical analgesics, corticosteroids, or antihistamines, unwilling or unable 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

Ibuprofen; Gels; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; 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: January 18, 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)