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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00849992
Recruitment Status : Completed
First Posted : February 24, 2009
Last Update Posted : May 15, 2017
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Actinic Cheilitis Drug: Imiquimod 5% Procedure: Photodynamic therapy Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Prospective Study Comparing 5% Imiquimod and Photodynamic Therapy for Actinic Cheilitis
Actual Study Start Date : March 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Arm Intervention/treatment
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

Photodynamic therapy
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.

Primary Outcome Measures :
  1. clinical and pathological complete cure rates. [ Time Frame: 3 and 12 months after therapy ]

Secondary Outcome Measures :
  1. clinical, safety, epidemiological and histopathological data [ Time Frame: post-treatment ]
    Through collecting patient data and post-treatment biopsy

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00849992

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St. Olavs Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
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Principal Investigator: Stein H Sundstrøm, PhD St. Olavs Hospital
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Responsible Party: Norwegian University of Science and Technology Identifier: NCT00849992    
Other Study ID Numbers: 20115
First Posted: February 24, 2009    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Actinic cheilitis
Imiquimod 5%
Photodynamic therapy
Additional relevant MeSH terms:
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Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers