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

NCT06159842 | Completed Phase 2 FDA Drug

• 1 other identifier: CCCR 03-2023
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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 cream 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 12 visits in total and will receive a total of two treatments, after voluntarily consent has been given.

Conditions

Facial Cutaneous Squamous Cell Carcinoma in Situ

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with Histological Clearance of treated isSCC lesion

  Histological clearance is defined as the absence of detectable evidence of isSCC tumor cell nests by the central pathology reports

  Up to 16 weeks

Secondary Outcomes (2)

• Number of participants with clinical clearance of treated isSCC lesion

  through treatment completion, an average of 12 weeks

• Local Skin Response Scale

  up to 16 weeks

Study Arms (1)

Photodynamic Therapy (Blue light dose 10 J/cm2 at 10 mW/cm2)

EXPERIMENTAL

30 participants will be enrolled to this arm

Combination Product: Aminolevulinic Acid 20% Topical Solution with Blue Light

Interventions

Aminolevulinic Acid 20% Topical Solution with Blue Light COMBINATION_PRODUCT

Participants will have their facial isSCC prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by blue light therapy administered for 16 minutes and 40 seconds to deliver the total desired light dose to the isSCC lesion.

Also known as: Levulan® Kerastick®, BLU-U® Blue Light Photodynamic Therapy Illuminator

Photodynamic Therapy (Blue light dose 10 J/cm2 at 10 mW/cm2)

Eligibility Criteria

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

You may qualify if:

• Must be an adult (18 years of age or older)
• Voluntary written consent required
• Must have a recently diagnosed (no more than six months from first study visit) facial isSCC lesion that meets surgery excision size requirements
• Cannot have other dermatological disease in the isSCC 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
• If female, cannot be pregnant before and during the study and agree to use acceptable forms of birth control

You may not qualify if:

• Sensitive to any of the study treatment ingredients
• Pregnant or lactating
• Medical laboratory evidence of other non-isSCC tumor in the target lesion biopsy specimen
• History of recurrence in the target isSCC lesion
• Medical laboratory evidence of certain 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

Sponsors & Collaborators

• The Center for Clinical and Cosmetic Research: lead
• Sun Pharmaceutical Industries Limited: collaborator

Study Sites (1)

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

MeSH Terms

Conditions

Skin Neoplasms; Carcinoma, Squamous Cell; Squamous Intraepithelial Lesions

Interventions

Aminolevulinic Acid; Solutions; Blue Light

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Pharmaceutical Preparations; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Study Officials

• Mark S Nestor, MD, PhD

  Center for Clinical and Cosmetic Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 7, 2023
• Study Start: August 8, 2023
• Primary Completion: September 11, 2024
• Study Completion: November 13, 2024
• Last Updated: February 12, 2025

Record last verified: 2024-08

Locations

US (1)