- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00849992
Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy
May 12, 2017 updated by: Norwegian University of Science and Technology
Randomized Prospective Study Comparing 5% Imiquimod and Photodynamic Therapy for Actinic Cheilitis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Randomized study comparing imiquimod 5% with photodynamic therapy for actinic cheilitis.
Histological, efficacy, epidemiological and clinical data will be collected.
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Trondheim, Norway, 7006
- St. Olavs Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Imiquimod 5%
Patients randomized to this arm will receive treatment with imiquimod 5%
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Imiquimod 5% cream used three days a week for 4 weeks
Other Names:
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OTHER: Photodynamic therapy
Patients will be randomized to receive photodynamic therapy twice at a 2 week interval to the affected area.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
clinical and pathological complete cure rates.
Time Frame: 3 and 12 months after therapy
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3 and 12 months after therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical, safety, epidemiological and histopathological data
Time Frame: post-treatment
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Through collecting patient data and post-treatment biopsy
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post-treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Stein H Sundstrøm, PhD, St. Olavs Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2009
Primary Completion (ACTUAL)
March 1, 2013
Study Completion (ACTUAL)
November 1, 2013
Study Registration Dates
First Submitted
February 23, 2009
First Submitted That Met QC Criteria
February 23, 2009
First Posted (ESTIMATE)
February 24, 2009
Study Record Updates
Last Update Posted (ACTUAL)
May 15, 2017
Last Update Submitted That Met QC Criteria
May 12, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20115
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Actinic Cheilitis
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Loyola UniversityWithdrawn
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Hospital de Clinicas de Porto AlegreFederal University of Rio Grande do SulTerminatedActinic CheilitisBrazil
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Nova Scotia Health AuthorityRecruiting
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Instituto Nacional de Cancer, BrazilWithdrawnActinic Cheilitis
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Dartmouth-Hitchcock Medical CenterDUSA Pharmaceuticals, Inc.CompletedActinic CheilitisUnited States
-
Dong-A UniversityCompletedActinic CheilitisKorea, Republic of
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Instituto Nacional de Cancer, BrazilUnknownLeukoplakia | Erythroplakia | Actinic Cheilitis
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Tufts Medical CenterDUSA Pharmaceuticals, Inc.CompletedActinic Cheilitis | Squamous Cell Carcinoma In-situ (SCC-is) | Squamous Cell Carcinoma (SCC) | Photodynamic Therapy (PDT) | Mohs SurgeryUnited States
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University of PalermoRecruitingOral Disease | Oral Cancer | Actinic Keratoses | Oral Leukoplakia | Oral Squamous Cell Carcinoma | Oral Lichen Planus | Graft-versus-host-disease | Proliferative Verrucous Leukoplakia | Actinic Cheilitis | Oral Potentially Malignant Disorder | Oral Erythroplakia | Oral Lichenoid LesionItaly
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Cosmetique Active InternationalNot yet recruiting
Clinical Trials on Imiquimod 5%
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Taro Pharmaceuticals USACompleted
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Graceway Pharmaceuticals, LLCCompletedSuperficial Basal Cell CarcinomaAustralia, New Zealand
-
St. Justine's HospitalGraceway Pharmaceuticals, LLCCompletedHemangioma, CapillaryCanada
-
Graceway Pharmaceuticals, LLCCompletedKeratosisUnited States
-
Graceway Pharmaceuticals, LLCCompletedActinic KeratosisUnited States
-
MEDA Pharma GmbH & Co. KGORION SanteCompleted
-
Massachusetts General HospitalCompletedNeurofibromatosis Type 1 | Cutaneous NeurofibromasUnited States
-
The Hospital for Sick ChildrenCompleted
-
Graceway Pharmaceuticals, LLCCompleted