search
Back to results

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

Primary Purpose

Actinic Keratoses

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Topical retinoid and blue-light therapy with photosensitizing agent
Photodynamic Therapy (PDT)
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratoses focused on measuring Actinic Keratoses, Blue light therapy, photosensitizer, Retinoid

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Topical retinoid and Light therapy with photosensitizing agent

    Light therapy with photosensitizing agent

    Outcomes

    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).

    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.

    Full Information

    First Posted
    September 19, 2008
    Last Updated
    December 2, 2021
    Sponsor
    Northwestern University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00756288
    Brief Title
    Photo-therapy With a Topical Retinoid Versus Photo-therapy Alone for Actinic Keratoses
    Official Title
    A Randomized Controlled Paired Comparison of Photo-therapy With a Topical Retinoid Cream Pretreatment Versus PDT Alone for Actinic Keratoses
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Northwestern University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Actinic Keratoses
    Keywords
    Actinic Keratoses, Blue light therapy, photosensitizer, Retinoid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Topical retinoid and Light therapy with photosensitizing agent
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Light therapy with photosensitizing agent
    Intervention Type
    Procedure
    Intervention Name(s)
    Topical retinoid and blue-light therapy with photosensitizing agent
    Intervention Description
    Topical Retinoid - Apply to AKs for 4 weeks Photo-therapy with photosensitizing agent- Apply to AKs at week 4
    Intervention Type
    Procedure
    Intervention Name(s)
    Photodynamic Therapy (PDT)
    Intervention Description
    Photo-therapy with sensitizing agent - apply to AKs at week 4
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Murad Alam, MD
    Organizational Affiliation
    Northwestern University Department of Dermatology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs