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

This study is not yet open for participant recruitment.

Verified by Norwegian University of Science and Technology, February 2009

First Received: February 23, 2009 No Changes Posted

Sponsors and Collaborators:	Norwegian University of Science and Technology St. Olavs Hospital
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00849992

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Randomized Prospective Study Comparing 5% Imiquimod and Photodynamic Therapy for Actinic Cheilitis

Resource links provided by NLM:

Drug Information available for: S 26308

U.S. FDA Resources

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

Primary Outcome Measures:

The end points of the study will be clinical and pathological complete cure rates. [ Time Frame: 3 and 12 months after therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Provide clinical, safety, epidemiological and histopathological data to improve management of patients with AC. [ Time Frame: Through collecting patient data and post-treatment biopsy ] [ Designated as safety issue: No ]

Estimated Enrollment:	124
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (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
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.
The following treatments are not allowed in the study area 4 weeks before enrollment in the study: prescribed topical retinoids, 5-fluorouracil, cryodestruction, surgical excision and curettage.

Contacts and Locations

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

Contacts

Contact: Kjetil KS Guldbakke, MD

0047-47377984

nordboerr@yahoo.no

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 University Hospital, Trondheim, Norway
Principal Investigator:	Stein Sundstrøm, PhD	St. Olavs University Hospital, Trondheim; Norway

More Information

Additional Information:

St. Olavs Hospital, Trondheim, Norway This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	St. Olavs Hospital ( Kjetil Guldbakke )
Study ID Numbers:	20115
Study First Received:	February 23, 2009
Last Updated:	February 23, 2009
ClinicalTrials.gov Identifier:	NCT00849992 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services; Norway: Directorate for Health and Social Affairs

Keywords provided by Norwegian University of Science and Technology:

Actinic cheilitis
Imiquimod 5%
Photodynamic therapy

Study placed in the following topic categories:

Mouth Diseases
Immunologic Factors
Interferons
Adjuvants, Immunologic
Methyl 5-aminolevulinate

Cheilitis
Imiquimod
Stomatognathic Diseases
Actinic Cheilitis

Additional relevant MeSH terms:

Mouth Diseases
Interferon Inducers
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Adjuvants, Immunologic
Cheilitis
Imiquimod
Stomatognathic Diseases
Lip Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 30, 2009