Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses

Derm Research @ 888

Status and phase

Completed

Phase 4

Conditions

Keratosis

Actinic Keratosis

Treatments

Drug: Imiquimod used as an adjunct to cryotherapy

Study type

Interventional

Funder types

Industry

Identifiers

DR 2004-05

Details and patient eligibility

About

Study Aims:

To compare the long-term efficacy and safety of imiquimod versus vehicle used as an adjunct to cryotherapy.
To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups.

Hypothesis: The imiquimod arm will produce a more prolonged clearing of Actinic Keratoses (AK) compared to the vehicle arm.

Full description

Evaluation of: (i) topical imiquimod 5% cream or (ii) vehicle cream used two times weekly for eight weeks starting two weeks post cryotherapy.

Study Aims:

To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups.
To assess and compare the efficacy of the 2 different treatment groups.
To assess and compare the safety of the 2 different treatment groups.

Study Design: 6 visits over 62 weeks

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of actinic keratosis with 4 or more discreet lesions on the face or balding scalp. Lesions must be within a treatment area not exceeding 50 cm2 (combined total must not exceed 50 cm2)
Women of childbearing potential using appropriate contraceptive methods

Exclusion criteria

Previous treatments with imiquimod for AK in the prescribed area within the past 5 months or cryosurgery in the same area within the past 4 weeks.
Patients unwilling to stay out of the sun or wear protective clothing or to use sunscreen with a minimum of SPF 15 during the study.
Basal or squamous cell carcinomas in the prescribed treatment area in the past 2 years.