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

NCT ID: NCT00756288

Last Updated: 2021-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Actinic Keratoses

Keywords

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Actinic Keratoses Blue light therapy photosensitizer Retinoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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1

Topical retinoid and Light therapy with photosensitizing agent

Group Type EXPERIMENTAL

Topical retinoid and blue-light therapy with photosensitizing agent

Intervention Type PROCEDURE

Topical Retinoid - Apply to AKs for 4 weeks Photo-therapy with photosensitizing agent- Apply to AKs at week 4

2

Light therapy with photosensitizing agent

Group Type ACTIVE_COMPARATOR

Photodynamic Therapy (PDT)

Intervention Type PROCEDURE

Photo-therapy with sensitizing agent - apply to AKs at week 4

Interventions

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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

Intervention Type PROCEDURE

Photodynamic Therapy (PDT)

Photo-therapy with sensitizing agent - apply to AKs at week 4

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Associate Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Department of Dermatology

Countries

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United States

Other Identifiers

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STU2574

Identifier Type: -

Identifier Source: org_study_id