Know Cancer

or
forgot password

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 4
18 Years
N/A
Not Enrolling
Both
Keratosis, Actinic Keratosis

Thank you

Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Recurrence rate and time to recurrence of lesions

Principal Investigator

Yves Poulin, MD FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre de Recherche Dermatologique du Quebec Metropolitaine

Authority:

Canada: Health Canada

Study ID:

DR 2004-05

NCT ID:

NCT00110682

Start Date:

April 2005

Completion Date:

December 2006

Related Keywords:

  • Keratosis
  • Actinic Keratosis
  • Actinic Keratosis
  • Cryotherapy
  • Imiquimod
  • Keratosis
  • Keratosis, Actinic
  • Ichthyosis
  • Keratoacanthoma

Name

Location