Safety and Effectiveness Study of Actinic Keratosis Treatment Following Cryosurgery

Completed · Phase 3 · Has a placebo group

Conditions studied: Actinic Keratosis

In brief

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).

Key facts

Study ID

NCT00894647

Run by

Graceway Pharmaceuticals, LLC

People needed

247

Starts

2009-05-01

Expected to finish

2010-02-01

Last updated by the study team

2010-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Dermatology Research Associates — Los Angeles, California, United States
• Therapeutics Clinical Research — San Diego, California, United States
• Spencer Dermatology & Skin Surgery Center — Saint Petersberg, Florida, United States
• Palm Beach Dermatology — West Palm Beach, Florida, United States
• MedaPhase, Inc. — Newnan, Georgia, United States
• Evanston Northwestern Healthcare — Skokie, Illinois, United States
• Skin Specialists PC — Omaha, Nebraska, United States
• Academic Dermatology Association — Albuquerque, New Mexico, United States
• DermResearchCenter of New York — Stony Brook, New York, United States
• Wake Forest Univ School of Medicine — Winston-Salem, North Carolina, United States
• Oregon Medical Research Center — Portland, Oregon, United States
• DermResearch Inc. — Austin, Texas, United States
• Dermatology Treatment and Research Center — Dallas, Texas, United States
• Progressive Clinical Research — San Antonio, Texas, United States
• Guildford Dermatology Specialists — Surrey, British Columbia, Canada
• Clinique de Dermatologie — Moncton, New Brunswick, Canada
• Ultranova Skincare — Barrie, Ontario, Canada
• Probity Medical Research — Waterloo, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.