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

This study is not yet open for participant recruitment.
Verified February 2013 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT00756288
First received: September 19, 2008
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756288

Contacts
Contact: Emily Poon 312-695-4761 research.nuderm@northwestern.edu

Locations
United States, Illinois
Northwestern University Department of Dermatology Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Emily Poon     312-695-4761     research.nuderm@northwestern.edu    
Principal Investigator: Murad Alam, MD            
Sub-Investigator: Dennis West, PhD            
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University Department of Dermatology
  More Information

No publications provided

Responsible Party: Murad Alam, Associate Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT00756288     History of Changes
Other Study ID Numbers: STU2574
Study First Received: September 19, 2008
Last Updated: February 7, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Ichthyosis
Keratoacanthoma
Skin Diseases
Precancerous Conditions
Neoplasms
Skin Abnormalities
 Congenital Abnormalities
Infant, Newborn, Diseases
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013