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

Study Overview
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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.

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

Conditions
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Actinic Keratoses

Intervention / Treatment
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* Procedure: Topical retinoid and blue-light therapy with photosensitizing agent
* Procedure: Photodynamic Therapy (PDT)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Topical retinoid and Light therapy with photosensitizing agent | Procedure: Topical retinoid and blue-light therapy with photosensitizing agent<br>* Topical Retinoid - Apply to AKs for 4 weeks Photo-therapy with photosensitizing agent- Apply to AKs at week 4<br>|
| Active Comparator: 2<br>Light therapy with photosensitizing agent | Procedure: Photodynamic Therapy (PDT)<br>* Photo-therapy with sensitizing agent - apply to AKs at week 4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Actinic Keratoses, Blue light therapy, photosensitizer, Retinoid