A Clinical Trial Evaluating the Role of Systemic Antihistamine Therapy in the Reduction of Adverse Effects Associated With Topical 5-aminolevulinic Acid Photodynamic Therapy

Study Overview
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Brief Summary
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A double-blind, placebo controlled study conducted at a single study site. Evaluating the role of systemic antihistamine therapy in the reduction of adverse effects associated with topical 5-aminolevulinic acid photodynamic therapy.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Prospective Clinical Trial Evaluating the Role of Systemic Antihistamine Therapy in the Reduction of Adverse Effects Associated With Topical 5-aminolevulinic Acid Photodynamic Therapy

Conditions
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Actinic Keratoses

Intervention / Treatment
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* Drug: Antihistamine Cetirizine Hydrochloride
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 Subjects with 5-20 actinic keratosis of the face Patients undergoing photodynamic therapy (PDT) to the face for AK with 5-aminolevulinic acid (ALA) activated by blue light. Must be willing to give and sign a HIPPA form, photo consent and informed consent form. Must be willing to comply with study dosing and complete the entire course of the study. Female patients will be either of non-childbearing potential defined as: Having no uterus No menses for at least 12 months. Or; (WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as: Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device Intrauterine coil Bilateral tubal ligation Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom) Abstinence (If practicing abstinence must agree to use barrier method described above (d) if becomes sexually active). Vasectomized partner g. Negative urine pregnancy test results Baseline prior to study entry (if applicable) Exclusion Criteria: Presence of incompletely healed wound in treatment area Presence of known or suspected BCC or SCC in treatment area Previous PDT or treatment of the face with any topical cytotoxic or immunomodulatory agent for AKs within the past 6 months Co-existing potentially confounding skin condition within treatment area (e.g. eczema, psoriasis, XP, rosacea) at investigator's discretion Presence of tattoo and/or scar in the treatment area that in the investigators opinion would interfere with study assessments Subjects with known photosensitivity or taking photosensitizing medications listed below: Oral diabetes medicines Griseofulvin Thiazide diuretics Sulfonylureas Phenothiazines Tetracycline's St. John's Wort Use of oral/topical retinoids within 1 month of Baseline Subjects with a history of sensitivity to porphyrins Subjects with recently excessive exposure of the treatment area to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study Female subjects who are pregnant, nursing an infant or planning a pregnancy during the study [throughout the course of the study Presence or evidence of any conditions that in the opinion of the investigator might impede the subject's ability to give consent or comply with protocol requirements. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study History of non-compliance with clinical research protocols Ablative laser resurfacing to on their face within 12 months Non-ablative laser or light procedures to their face within the past 3 months Microdermabrasion (light or medium skin peel) treatment on their face within the past 30 days

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: Cetirizine Hydrochloride<br>Prophylactic use of cetirizine hydrochloride prior to and after Topical 5-aminolevulinic Acid Photodynamic Therapy | Drug: Antihistamine Cetirizine Hydrochloride<br>* Prophylactic use of antihistamine prior to and following topical 5-aminolevulonic acid photodynamic therapy<br>|
| Placebo Comparator: Placebo<br>Prophylactic use of placebo prior to and after Topical 5-aminolevulinic Acid Photodynamic Therapy | Other: Placebo<br>* Use of placebo prior to and following topical 5-aminolevulonic acid photodynamic therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Localized Skin Response | Localized Skin Response consisting of erythema, edema, crusting, exudation, Vesiculation/Pustulation and erosion/ ulceration Investigator evaluated on a standardized scale | Up to day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photodynamic Therapy, Blue Light, PDT, Actinic Keratoses