Trial | NCT00110682  Report issue

Title

Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses
A Randomized, Parallel-Group, Vehicle-Controlled, Double-Blind Study of Topical Imiquimod 5% Cream Used as an Adjunct to Cryotherapy in the Management of Actinic Keratoses, With a Long-Term (1 Year) Follow-Up

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    imiquimod ...

  • Study Participants

    60
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.
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
Study Started
Apr 30
2005
Primary Completion
Oct 31
2006
Study Completion
Dec 31
2006
Last Update
Apr 24
2008
Estimate

Drug Imiquimod used as an adjunct to cryotherapy

Criteria 

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.
No Results Posted