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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 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: December 17, 2013
Last verified: December 2013
  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:


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: January 2014
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 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
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, see Learn About Clinical Studies.

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: December 17, 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
Skin Diseases
Precancerous Conditions
Neoplasms
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014