NCT02451579

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

May 12, 2015

Last Update Submit

February 27, 2017

Conditions

Actinic Keratoses

Keywords

Actinic KeratosesPhotodynamic TherapyPDTBlue Light

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Cetirizine Hydrochloride

ACTIVE COMPARATOR

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

Drug: Antihistamine Cetirizine Hydrochloride

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Antihistamine Cetirizine HydrochlorideDRUG

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

Cetirizine Hydrochloride
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • +1 more criteria

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

Related Publications (1)

  • 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.

    PMID: 28489298DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mitchel P Goldman, MD

    Cosmetic Laser Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 22, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations

US(1)