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

February 27, 2017 updated by: Goldman, Butterwick, Fitzpatrick and Groff

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 92121
        • Cosmetic Laser Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

    1. Having no uterus
    2. 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:

  1. Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
  2. Intrauterine coil
  3. Bilateral tubal ligation
  4. Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
  5. Abstinence (If practicing abstinence must agree to use barrier method described above (d) if becomes sexually active).
  6. 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:

    1. Oral diabetes medicines
    2. Griseofulvin
    3. Thiazide diuretics
    4. Sulfonylureas
    5. Phenothiazines
    6. Tetracycline's
    7. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cetirizine Hydrochloride
Prophylactic use of cetirizine hydrochloride prior to and after Topical 5-aminolevulinic Acid Photodynamic Therapy
Prophylactic use of antihistamine prior to and following topical 5-aminolevulonic acid photodynamic therapy
Placebo Comparator: Placebo
Prophylactic use of placebo prior to and after Topical 5-aminolevulinic Acid Photodynamic Therapy
Use of placebo prior to and following topical 5-aminolevulonic acid photodynamic therapy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

May 12, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimate)

May 22, 2015

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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