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Photo-therapy With a Topical Retinoid Versus Photo-therapy Alone for Actinic Keratoses

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00756288
First Posted: September 22, 2008
Last Update Posted: August 30, 2016
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.
Information provided by (Responsible Party):
Murad Alam, Northwestern University
  Purpose
Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy for the treatment of actinic keratoses.

Condition Intervention
Actinic Keratoses Procedure: Topical retinoid and blue-light therapy with photosensitizing agent Procedure: Photodynamic Therapy (PDT)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Paired Comparison of Photo-therapy With a Topical Retinoid Cream Pretreatment Versus PDT Alone for Actinic Keratoses

Resource links provided by NLM:


Further study details as provided by Murad Alam, Northwestern University:

Primary Outcome Measures:
  • Live blinded rater and blinded photo rater analysis of areas at week 0 and week 6 for erythema, edema, crusting, ulceration, palpability, need to cease/delay treatment, and overall response in reduction of number of actinic keratoses (AKs). [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Subjects will assess pain, burning and itching on a scale of 0-3 at week 0, during retinoid treatment, during photo-therapy, one day after, and week 6. Also, principal investigator will evaluate adverse events at week 6. [ Time Frame: 6 weeks ]

Enrollment: 0
Study Start Date: March 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Topical retinoid and Light therapy with photosensitizing agent
Procedure: Topical retinoid and blue-light therapy with photosensitizing agent
Topical Retinoid - Apply to AKs for 4 weeks Photo-therapy with photosensitizing agent- Apply to AKs at week 4
Active Comparator: 2
Light therapy with photosensitizing agent
Procedure: Photodynamic Therapy (PDT)
Photo-therapy with sensitizing agent - apply to AKs at week 4

Detailed Description:
Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy vs photodynamic therapy alone for the treatment of actinic keratoses.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Adults aged 18-80 years old
  • Subjects with AK lesions who will receive PDT
  • Subjects with AK lesions in two areas other than face and scalp each with a surface area of 10cm2 or greater and at least 3 clinically diagnosed non-hypertrophic AK lesions in each
  • Subjects in good health
  • Subjects with willingness and the ability to understand and provide informed consent

Exclusion Criteria

  • Subjects who are pregnant or lactating
  • Subjects with a history of cutaneous photosensitivity or porphyria, hypersensitivity to porphyrins, or photodermatosis
  • Subjects with use of photosensitizing drugs within 1 week of study start
  • Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry
  • Subjects who received previous treatment of target AKs within 4 weeks
  • Subjects who are unable to understand the protocol or give informed consent
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00756288


Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University Department of Dermatology
  More Information

Responsible Party: Murad Alam, Associate Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT00756288     History of Changes
Other Study ID Numbers: STU2574
First Submitted: September 19, 2008
First Posted: September 22, 2008
Last Update Posted: August 30, 2016
Last Verified: August 2016

Keywords provided by Murad Alam, Northwestern University:
Actinic Keratoses
Blue light therapy
photosensitizer
Retinoid

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Photosensitizing Agents
Dermatologic Agents