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Completed

NCT Number: NCT00849992

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

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.

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Key information

Conditions

Actinic Cheilitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Olavs Hospital

Trondheim, 7006, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Imiquimod 5%

Drug

Imiquimod 5% cream used three days a week for 4 weeks

Other names: Aldara

Photodynamic Therapy

Procedure

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 outcomes

  1. clinical and pathological complete cure rates.

    Time frame: 3 and 12 months after therapy

Secondary outcomes

  1. clinical, safety, epidemiological and histopathological data

    Time frame: post-treatment

    Through collecting patient data and post-treatment biopsy

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 24, 2009
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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