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

Brief Title

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

Official Title

Randomized Prospective Study Comparing 5% Imiquimod and Photodynamic Therapy for Actinic Cheilitis

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.
    

Detailed Description

      Randomized study comparing imiquimod 5% with photodynamic therapy for actinic cheilitis.
      Histological, efficacy, epidemiological and clinical data will be collected.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

clinical and pathological complete cure rates.

Secondary Outcome

 clinical, safety, epidemiological and histopathological data

Condition

Actinic Cheilitis

Intervention

Imiquimod 5%

Study Arms / Comparison Groups

 Imiquimod 5%
Description:  Patients randomized to this arm will receive treatment with imiquimod 5%

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

53

Start Date

March 2009

Completion Date

November 2013

Primary Completion Date

March 2013

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Stein H Sundstrøm, PhD, , 

Location Countries

Norway

Location Countries

Norway

Administrative Informations


NCT ID

NCT00849992

Organization ID

20115


Responsible Party

Sponsor

Study Sponsor

Norwegian University of Science and Technology

Collaborators

 St. Olavs Hospital

Study Sponsor

Stein H Sundstrøm, PhD, Principal Investigator, St. Olavs Hospital


Verification Date

May 2017