Daylight Photodynamic Therapy for Actinic Keratosis

NCT03322293 | Completed Phase 1 Results FDA Drug FDA Device

• 1 other identifier: Daylight PDT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, single-blind controlled trial with parallel group design to determine whether daylight photodynamic therapy (PDT) affords a reduction in treatment symptoms of pain, burning, and pruritus as measured by 1) symptom level during the treatment period and 2) pain at the end of treatment exposure.

Conditions

Actinic Keratoses

Keywords

Actinic Keratoses; photodynamic therapy; aminolevulinic acid; precancerous skin lesion

Outcome Measures

Primary Outcomes (1)

• Change in Treatment Symptoms

  Primary objective is to determine whether daylight PDT changes treatment symptoms of pain, stinging/burning, and itching/pruritus. This was measured using a visual analog scale from 0-10, with higher scores indicating worse treatment symptoms, or more pain/burning/itching. Lower scores indicate less pain, burning/stinging, and itching/pruritus. Positive numbers represent increases in symptoms and negative numbers represent decreases.

  12 weeks

Secondary Outcomes (4)

• Percent Change in AK Lesion Count

  12 weeks

• Reduction of AK Counts

  12 weeks

• Change in Local Skin Reaction From Pre-treatment to 12 Weeks Post-treatment

  12 weeks

• Peak Pain Score at Day 8 Post-treatment

  8 days post-treatment

Study Arms (3)

A. Conventional arm

ACTIVE COMPARATOR

This is considered the standard of care arm for photodynamic therapy for the treatment of actinic keratosis. This treatment arm includes: Acetone preparation, ALA topical application, 1 hour incubation, 16 minutes 40 seconds (16:40) BLU-U exposure, application of sunscreen. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator

Drug: Aminolevulinic Acid Topical 20% Topical Solution; Device: BLU-U blue light phototherapy illuminator

B. Combination arm

EXPERIMENTAL

This treatment arm combines standard of care BLU-U exposure and daylight exposure. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, 16:40 BLU-U exposure, application of sunscreen, 45 minute daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator

Drug: Aminolevulinic Acid Topical 20% Topical Solution; Device: BLU-U blue light phototherapy illuminator

C. Daylight arm

EXPERIMENTAL

This is the experimental arm. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, application of sunscreen, 1 hour daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: none

Drug: Aminolevulinic Acid Topical 20% Topical Solution

Interventions

Aminolevulinic Acid Topical 20% Topical Solution DRUG

PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).

A. Conventional arm; B. Combination arm; C. Daylight arm

BLU-U blue light phototherapy illuminator DEVICE

Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.

A. Conventional arm; B. Combination arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults at least 18 years old.
• Subjects must be able to read, sign, and understand the informed consent
• Subjects have at least 4 and no more than 20 clinically typical, visible actinic keratoses in the target treatment area on the face or scalp.
• Subject must be willing to forego any other treatments for AK in the treatment area on the face or scalp, during the study period, and for 14 days prior to screening; including cryotherapy, topical 5-fluorouracil, imiquimod, and ingenol mebutate.
• Subjects who have previously received PDT must undergo at least an 8-week washout period prior to enrollment in study.
• Subject must be willing and able to participate in the study and to comply with all study requirements including concomitant medication and other treatment restrictions, and telephone interview.
• If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study. Women who are pregnant, lactating, or planning to become pregnant during the study period are excluded from the study.

You may not qualify if:

• Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of AKs.
• Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device on the study area within 30 days prior to study treatment initiation.
• Subjects with any medical condition that, in the opinion of the investigator, makes the patient unsuitable for the trial.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Dermatology

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Aminolevulinic Acid; Solutions

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Pharmaceutical Preparations

Limitations and Caveats

This was a small, 24 person pilot study performed at the San Francisco Veterans Affairs Medical Center. As such, the study was not powered to detect statistically significant differences in treatment efficacies.

Results Point of Contact

• Title: Dr. Sarah Arron, MD, PhD
• Organization: University of California San Francisco Dept. of Dermatology

sarah.arron@ucsf.edu

415-353-9684

Study Officials

• Sarah Arron, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: This is a single-blinded study, as the subject cannot be blinded to treatment. Disease assessments and aminolevulinic acid (ALA) application will be performed by the blinded investigator. History, concomitant medications, randomization, light exposure, symptom assessment, and Skindex-16 will be administered by the unblinded study coordinator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized (1:1:1), single-blind controlled trial with parallel group design

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: October 26, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: July 1, 2019
• Last Updated: March 9, 2022
• Results First Posted: October 4, 2019

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)