Clinical trial NCT00110682: Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Keratosis
Actinic Keratosis
Keywords: Actinic Keratosis
Cryotherapy
Imiquimod
Lead sponsor: Derm Research @ 888 Inc.
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2005-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility 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.

Primary outcomes:
measure: Recurrence rate and time to recurrence of lesions
Secondary outcomes:
measure: Time to reach treatment success
measure: Percentage of patients who clear
measure: Patient improvement assessment
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: DermResearch @ 888 Inc
state: British Columbia
city: Windsor
country: Canada
facility: Windsor Clinical Research
state: Ontario
city: Sainte-Foy
country: Canada
facility: Centre de Recherche Dermatologique, CRDQ
state: Quebec
Study officials:
affiliation: Centre de Recherche Dermatologique du Quebec Metropolitaine
name: Yves Poulin, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: U. of Western Ontario, Windsor Ontario
name: Jerry KL Tan, MD FDRPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Derm Research @ 888 Inc.
name: Richard Thomas, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: