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

Northwestern University

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Actinic Keratoses

Interventions

Topical retinoid and blue-light therapy with photosensitizing agentPROCEDURE

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

Photodynamic Therapy (PDT)PROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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