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

Sponsor

Northwestern University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00756288

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Actinic Keratoses	Procedure: Topical retinoid and blue-light therapy with photosensitizing agent Procedure: Photodynamic Therapy (PDT)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

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

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

Outcome Measures

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). [6 weeks]

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. [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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