Daylight Photodynamic Therapy for the Treatment of Actinic Keratoses in the Northeast United States

NCT02867722 | Withdrawn DMC

• 1 other identifier: 2016P000913
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, daylight PDT will be administered to interested patients at Dana-Farber/Brigham and Women's Cancer Center. Daylight PDT has been shown to be an effective and painless alternative to traditional PDT. Daylight PDT involves application of the photosensitizer in the physician's office followed by exposure to daylight.

Conditions

Actinic Keratosis; Non-melanoma Skin Cancer

Outcome Measures

Primary Outcomes (1)

• Number of patients with reduction in the number of actinic keratoses after daylight PDT treatment

  1 year and 5 years

Secondary Outcomes (3)

• Number of non-melanoma skin cancers at 1- and 5-years compared to the number of skin

  1 year and 5 years

• Number of patients with treatment related adverse events as assessed by CTCAE v4.0

  5 years

• Measure patient satisfaction at 1- and 5- years using the Treatment Satisfaction Questionnaire for Medication

  1 year and 5 years

Study Arms (1)

Daylight PDT

EXPERIMENTAL

Patients will receive daylight-PDT treatment (aminolevulinic acid)

Drug: aminolevulinic acid HCl

Interventions

aminolevulinic acid HCl DRUG

Drug will be administered to consented patients

Also known as: Levulan

Daylight PDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years referred for the treatment of 5 or more visible or palpable actinic keratoses on one treatment area

You may not qualify if:

• Age less than 18 years of age.
• Pregnant women.
• Non-English speaking patients.
• Treatment of actinic keratoses with other modalities including topical 5-fluorouracil, topical imiquimod, conventional PDT, alpha-hydroxy-acids, and glycolic acids within 2 months
• Use of retinoids within 1 month
• Use of the following medications: griseofulvin, thiazide diuretics, sulfonyureas, phenothiazines, sulfonamides, and tetracyclines
• History of cutaneous photosensitivity, lupus, porphyrias, or any other photosensitizing condition

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Aminolevulinic Acid

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

Study Officials

• Emily Stamell Ruiz, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: August 16, 2016
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share