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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00110682

Enrollment

Registered

2005-05-13

Start date

2005-04-30

Completion date

2006-12-31

Last updated

2008-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis, Keratosis

Keywords

Actinic Keratosis, Cryotherapy, Imiquimod

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

Interventions

DRUGImiquimod used as an adjunct to cryotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Recurrence rate and time to recurrence of lesions	—

Secondary

Measure	Time frame
Time to reach treatment success	—
Percentage of patients who clear	—
Patient improvement assessment	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026