- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02451579
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
Intervention / Treatment
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:
- 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
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.
Collaborators
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
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Precancerous Conditions
- Keratosis, Actinic
- Keratosis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Allergic Agents
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Cetirizine
- Histamine H1 Antagonists
- Histamine Antagonists
Other Study ID Numbers
- PDT-2015-01
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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