Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy

This study has been completed.
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology Identifier:
First received: February 23, 2009
Last updated: August 11, 2014
Last verified: August 2014
Actinic cheilitis is a common precancerous lesion of the lip. The purpose of this study is to compare imiquimod 5% therapy and photodynamic therapy. The data will include effect data, histology (skin analysis), epidemiological data and follow-up data.

Condition Intervention Phase
Actinic Cheilitis
Drug: Imiquimod 5%
Procedure: Photodynamic therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Prospective Study Comparing 5% Imiquimod and Photodynamic Therapy for Actinic Cheilitis

Resource links provided by NLM:

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • clinical and pathological complete cure rates. [ Time Frame: 3 and 12 months after therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical, safety, epidemiological and histopathological data [ Time Frame: post-treatment ] [ Designated as safety issue: No ]
    Through collecting patient data and post-treatment biopsy

Enrollment: 53
Study Start Date: March 2009
Study Completion Date: November 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Imiquimod 5%
Patients randomized to this arm will receive treatment with imiquimod 5%
Drug: Imiquimod 5%
Imiquimod 5% cream used three days a week for 4 weeks
Other Name: Aldara
Patients will be randomized to receive photodynamic therapy twice at a 2 week interval to the affected area.
Procedure: Photodynamic therapy
Photodynamic therapy involves applying Metvix cream to the affected area followed by illumination. It will be done twice during the study at a 2 week interval.

Detailed Description:
Randomized study comparing imiquimod 5% with photodynamic therapy for actinic cheilitis. Histological, efficacy, epidemiological and clinical data will be collected.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical findings of actinic cheilitis.
  • Histological findings demonstrating epithelial changes equal to or greater than mild epithelial dysplasia in severity (mild - moderate - severe).
  • Age above 18.
  • Willingness to take post-treatment biopsy.

Exclusion Criteria:

  • Disorders predisposing to photosensitivity (porphyria, SLE).
  • Pregnancy or nursing.
  • Known allergy to any excipients in the study creams.
  • prescribed topical retinoids, 5-fluorouracil, cryodestruction, surgical excision and curettage.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00849992

St. Olavs Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Principal Investigator: Kjetil KS Guldbakke, MD St. Olavs Hospital
Principal Investigator: Stein Sundstrøm, PhD St. Olavs Hospital
  More Information

Additional Information:
Responsible Party: Norwegian University of Science and Technology Identifier: NCT00849992     History of Changes
Other Study ID Numbers: 20115 
Study First Received: February 23, 2009
Last Updated: August 11, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

Keywords provided by Norwegian University of Science and Technology:
Actinic cheilitis
Imiquimod 5%
Photodynamic therapy

Additional relevant MeSH terms:
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Interferon Inducers
Physiological Effects of Drugs processed this record on May 26, 2016