Photo-Therapy With a Topical Retinoid Versus Photo-Therapy Alone for Actinic Keratoses - Full Text View

Sponsored by:	Northwestern University
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00756288

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)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Controlled Paired Comparison of Photo-Therapy With a Topical Retinoid Cream Pretreatment Versus PDT Alone for Actinic Keratoses

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 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:	August 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Active Comparator 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: Jenneé A Rommel, MD	(312) 695-8181	j-rommel@northwestern.edu
Contact: Natalie Kim	(312) 695-6785	nkim@northwestern.edu

Locations

United States, Illinois
Northwestern University, Department of Dermatology	Recruiting
Chicago, Illinois, United States, 60611
Contact: Jenneé A Rommel, MD 312-695-8181 j-rommel@northwestern.edu
Contact: Natalie Kim (312) 695-6785 nkim@northwestern.edu
Sub-Investigator: Jenneé Rommel A Rommel, MD
Principal Investigator: Murad Alam, MD
Sub-Investigator: Natalie Kim
Sub-Investigator: Shraddha Desai, MD
Sub-Investigator: Dennis West, PhD
Sub-Investigator: Sara Ortiz

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:	Murad Alam, MD	Northwestern University, Department of Dermatology
Study Chair:	Jenneé A Rommel, MD	Northwestern Univeristy, Department of Dermatology

More Information

No publications provided

Responsible Party:	Northwestern University, Department of Dermatology ( Murad Alam, MD )
Study ID Numbers:	MA-071508
Study First Received:	September 19, 2008
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00756288 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:

Actinic Keratoses
Blue light therapy
photosensitizer
Retinoid

Study placed in the following topic categories:

Photosensitizing Agents
Keratosis
Radiation-Sensitizing Agents
Skin Diseases
Tylosis

Additional relevant MeSH terms:

Photosensitizing Agents
Keratosis
Radiation-Sensitizing Agents
Skin Diseases

Therapeutic Uses
Physiological Effects of Drugs
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009