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

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.

Conditions

Cutaneous Squamous Cell Carcinoma

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Study Overview

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Study Details

Study overview

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.

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)"

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

Condition
Cutaneous Squamous Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Aventura

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Center for Clinical and Cosmetic Research,

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

Study Record Dates

2025-08