Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy
Randomized Prospective Study Comparing 5% Imiquimod and Photodynamic Therapy for Actinic Cheilitis
1 other identifier
interventional
53
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2009
CompletedFirst Posted
Study publicly available on registry
February 24, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedMay 15, 2017
May 1, 2017
4 years
February 23, 2009
May 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
clinical and pathological complete cure rates.
3 and 12 months after therapy
Secondary Outcomes (1)
clinical, safety, epidemiological and histopathological data
post-treatment
Study Arms (2)
Imiquimod 5%
OTHERPatients randomized to this arm will receive treatment with imiquimod 5%
Photodynamic therapy
OTHERPatients will be randomized to receive photodynamic therapy twice at a 2 week interval to the affected area.
Interventions
Imiquimod 5% cream used three days a week for 4 weeks
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
Study Sites (1)
St. Olavs Hospital
Trondheim, 7006, Norway
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stein H Sundstrøm, PhD
St. Olavs Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2009
First Posted
February 24, 2009
Study Start
March 1, 2009
Primary Completion
March 1, 2013
Study Completion
November 1, 2013
Last Updated
May 15, 2017
Record last verified: 2017-05