Status:
COMPLETED
Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis
Lead Sponsor:
Graceway Pharmaceuticals, LLC
Conditions:
Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The purpose of this study is to evaluat...
Detailed Description
This was a Phase 4, open-label, single-arm, multicenter study in male and female subjects aged 18 years or older with clinically diagnosed AK lesions, conducted at 31 investigational sites in the Unit...
Eligibility Criteria
Inclusion
- Are at least 18 years of age.
- Have greater than 25 cm2 total treatment area(s) containing at least 4 actinic keratosis lesions.
Exclusion
- Have any skin condition in the treatment area that may be made worse by treatment with imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema).
- Have received specific treatments/medications in the treatment area(s) within the designated time period prior to study treatment initiation.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
551 Patients enrolled
Trial Details
Trial ID
NCT00116649
Start Date
June 1 2005
End Date
May 1 2007
Last Update
July 20 2010
Active Locations (32)
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1
Phoenix, Arizona, United States, 85044
2
Encino, California, United States, 91436
3
Los Angeles, California, United States, 90045
4
Riverside, California, United States, 92506