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Completed

NCT Number: NCT00110682

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

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.

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Key information

Conditions

Keratosis Actinic Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

DermResearch @ 888 Inc, Vancouver, British Columbia, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Imiquimod used as an adjunct to cryotherapy

Drug

Primary outcomes

  1. Recurrence rate and time to recurrence of lesions

Secondary outcomes

  1. Time to reach treatment success

  2. Percentage of patients who clear

  3. Patient improvement assessment

Sponsors and collaborators

Lead sponsor

Derm Research @ 888 Inc.

Industry

Collaborators

  • 3M

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
May 13, 2005
Registry last updated
Apr 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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