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

NCT ID: NCT00756288

Last Updated: 2021-12-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-12-31

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.

Conditions

Actinic Keratoses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

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

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

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Murad Alam

Associate Professor of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Department of Dermatology

Other Identifiers

STU2574

Identifier Type: -

Identifier Source: org_study_id