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

December 2, 2021 updated by: Murad Alam, Northwestern University

A Randomized Controlled Paired Comparison of Photo-therapy With a Topical Retinoid Cream Pretreatment Versus PDT Alone for Actinic Keratoses

Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy for the treatment of actinic keratoses.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Murad Alam, MD, Northwestern University Department of Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 19, 2008

First Submitted That Met QC Criteria

September 19, 2008

First Posted (Estimate)

September 22, 2008

Study Record Updates

Last Update Posted (Actual)

December 6, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU2574

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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