RECRUITING

Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to test how safe and effective it is to treat early form of cancer cells found in the upper skin layer of the face, using a light-sensitive gel used in combination with a light source. The main questions this trial aims to answer are: * to confirm using laboratory testing, how much of the affected facial skin cancer section the treatment was able to remove, and; * seeing how many participants had no remaining affected facial skin cancer sections after treatment. Participants who qualify will be asked to complete 14 visits in total and will receive a total of two treatments, after voluntarily consent has been given.

Official Title

An Investigator Initiated Study to Evaluate the Safety and Efficacy of Aminolevulinic Acid Hydrochloride Topical Gel, 10% (Ameluz ®) With RhodoLED-XL® Red Light in the Treatment of Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis)"

Quick Facts

Study Start:2024-08-14
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06577311

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must be an adult (18 years of age or older)
  2. * Must have a recently diagnosed (no more than six months from first study visit) facial SCCis lesion that meets surgery excision size requirements
  3. * Cannot have other dermatological disease in the SCCis target area
  4. * Must be willing to follow study instructions and complete study requirements, including not using non-approved lotions and creams on the treatments areas
  5. * Voluntary written consent required
  6. * Allow photographs of the area of skin cancer being treated on the face
  7. * Agree to use acceptable forms of birth control. If female, cannot be pregnant before and during the study
  1. * Pregnant or lactating
  2. * Sensitive to any of the study treatment ingredients
  3. * Medical laboratory evidence of other non-SCCis tumor in the target lesion biopsy specimen
  4. * History of recurrence if the target SCCis lesion
  5. * Evidence of dermatological disease or skin condition in the treatment area
  6. * Medical laboratory evidence of growth patterns in the target lesion biopsy specimen
  7. * Chronic medical condition that in the Investigators opinion will interfere in the trial or affect participant safety.

Contacts and Locations

Study Contact

Clinical Coordinator
CONTACT
305-933-6716
info@centerforclinicalandcosmeticresearch.com

Principal Investigator

Mark S Nestor, MD, PhD
PRINCIPAL_INVESTIGATOR
Center for Clinical and Cosmetic Research

Study Locations (Sites)

Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
United States

Collaborators and Investigators

Sponsor: The Center for Clinical and Cosmetic Research

  • Mark S Nestor, MD, PhD, PRINCIPAL_INVESTIGATOR, Center for Clinical and Cosmetic Research

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 Registration Dates

Study Start Date2024-08-14
Study Completion Date2025-08

Study Record Updates

Study Start Date2024-08-14
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • skin cancer
  • facial skin cancer
  • Squamous Cell Carcinoma
  • Squamous Cell Carcinoma in Situ
  • Cutaneous Squamous Cell Carcinoma in Situ
  • Facial Cutaneous Squamous Cell Carcinoma in Situ
  • SCCis

Additional Relevant MeSH Terms

  • Cutaneous Squamous Cell Carcinoma