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

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00849992
First received: February 23, 2009
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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
2
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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849992

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

Additional Information:
No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov 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:
Cheilitis
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Imiquimod
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Interferon Inducers
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014