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

NCT ID: NCT02451579

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-01-31

Brief Summary

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.

Conditions

Actinic Keratoses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cetirizine Hydrochloride

Prophylactic use of cetirizine hydrochloride prior to and after Topical 5-aminolevulinic Acid Photodynamic Therapy

Group Type: ACTIVE_COMPARATOR

Antihistamine Cetirizine Hydrochloride

Intervention Type: DRUG

Prophylactic use of antihistamine prior to and following topical 5-aminolevulonic acid photodynamic therapy

Placebo

Prophylactic use of placebo prior to and after Topical 5-aminolevulinic Acid Photodynamic Therapy

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Use of placebo prior to and following topical 5-aminolevulonic acid photodynamic therapy

Interventions

Antihistamine Cetirizine Hydrochloride

Prophylactic use of antihistamine prior to and following topical 5-aminolevulonic acid photodynamic therapy

Intervention Type: DRUG

Placebo

Use of placebo prior to and following topical 5-aminolevulonic acid photodynamic therapy

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DUSA Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Goldman, Butterwick, Fitzpatrick and Groff

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchel P Goldman, MD

Role: PRINCIPAL_INVESTIGATOR

Cosmetic Laser Dermatology

Locations

Cosmetic Laser Dermatology

San Diego, California, United States

Countries

United States

References

Vanaman Wilson MJ, Jones IT, Wu DC, Goldman MP. A randomized, double-blind, placebo-controlled clinical trial evaluating the role of systemic antihistamine therapy for the reduction of adverse effects associated with topical 5-aminolevulinic acid photodynamic therapy. Lasers Surg Med. 2017 Oct;49(8):738-742. doi: 10.1002/lsm.22682. Epub 2017 May 10.

Reference Type: DERIVED

PMID: 28489298 (View on PubMed)

Other Identifiers

PDT-2015-01

Identifier Type: -

Identifier Source: org_study_id