Status:
COMPLETED
Safety and Effectiveness Study of Actinic Keratosis Treatment Following Cryosurgery
Lead Sponsor:
Graceway Pharmaceuticals, LLC
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to evaluate the efficacy and safety of imiquimod cream versus placebo cream when used after cryosurgery in the treatment of actinic keratoses (AKs).
Detailed Description
In this multicenter, randomized, double-blind, placebo-controlled study, the efficacy and safety of imiquimod 3.75% cream following cryosurgery to treat clinically typical visible or palpable AK lesio...
Eligibility Criteria
Inclusion
- In good general health
- Negative urine pregnancy test (for women of child-bearing potential) and agree to use an approved method of birth control while enrolled in the study.
- Prior to cryosurgery, have ≥ 10 clinically typical (visible or palpable) AKs in an area that exceeds 25 cm2 on the face.
- Must have had cryosurgery on 5 to 14 AKs on the face after giving informed consent and prior to receiving study medication. Lesions previously treated with cryosurgery must be healed sufficiently prior to randomization to study cream.
- Following cryosurgery, have ≥ 5 clinically typical (visible or palpable) AKs in an area that exceeds 25 cm2 on the face that are suitable for treatment with the study cream.
Exclusion
- Women who are pregnant, lactating, or planning to become pregnant during the study
- Had a medical event within 90 days of the visit (e.g., stroke, heart attack, etc.).
- 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 within the designated time period prior to study treatment initiation
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT00894647
Start Date
May 1 2009
End Date
February 1 2010
Last Update
August 31 2010
Active Locations (18)
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1
Dermatology Research Associates
Los Angeles, California, United States, 90045
2
Therapeutics Clinical Research
San Diego, California, United States, 92123
3
Spencer Dermatology & Skin Surgery Center
Saint Petersberg, Florida, United States, 33705
4
Palm Beach Dermatology
West Palm Beach, Florida, United States, 33401