Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy
This study is ongoing, but not recruiting participants.
Sponsor:
Norwegian University of Science and Technology
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: March 28, 2012
Last verified: March 2012
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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 |
| Estimated Study Completion Date: | November 2013 |
| Estimated 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
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 University Hospital, Trondheim, Norway |
| Principal Investigator: | Stein Sundstrøm, PhD | St Olavs University Hospital, Trondheim, Norway |
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: | March 28, 2012 |
| 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 |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Interferon Inducers |
ClinicalTrials.gov processed this record on May 22, 2013