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

NCT06577311 | Recruiting Phase 2 FDA Drug

• 1 other identifier: CCCR 01-2024
• Study Type: interventional
• Target: 20
• 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 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

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; SCCis

Outcome Measures

Primary Outcomes (1)

• Number of participants with histological clearance of treated SCCis lesion.

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

  an average of 12 weeks

Secondary Outcomes (3)

• Number of participants with clinical clearance of treated SCCis lesion

  an average of 12 weeks

• Size of the lesion

  Up to 16 weeks

• Local Skin Response Scale

  Up to 16 weeks

Study Arms (1)

Photodynamic Therapy (using Red light dose)

EXPERIMENTAL

20 participants will be enrolled to this arm

Combination Product: Aminolevulinic acid hydrochloride 10% topical gel with Red Light

Interventions

Aminolevulinic acid hydrochloride 10% topical gel with Red Light COMBINATION_PRODUCT

Participants will have their facial Cutaneous Squamous Cell Carcinoma in situ (SCCis) prepped then treated with Aminolevulinic acid hydrochloride 10% topical gel (Ameluz ®), followed by red light therapy administered for 13 minutes and 30 seconds to deliver the total desired light dose to the SCCis lesion.

Also known as: Ameluz ®, RhodoLED-XL®

Photodynamic Therapy (using Red light dose)

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)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Center for Clinical and Cosmetic Research: lead
• Biofrontera Inc.: collaborator

Study Sites (1)

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

RECRUITING

MeSH Terms

Conditions

Skin Neoplasms; Carcinoma, Squamous Cell; Squamous Intraepithelial Lesions

Interventions

Aminolevulinic Acid; Gels; Red 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; Colloids; Complex Mixtures; Dosage Forms; 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

Central Study Contacts

Clinical Coordinator

CONTACT

305-933-6716; info@centerforclinicalandcosmeticresearch.com

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: August 27, 2024
• First Posted: August 29, 2024
• Study Start: August 14, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

US (1)