Overview

Safety and Effectiveness Study of Actinic Keratosis Treatment Following Cryosurgery

Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Graceway Pharmaceuticals, LLC
Treatments:
Imiquimod
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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