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

NCT ID: NCT06159842

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-08
• Study Completion Date: 2024-11-13

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.

Detailed Description

In the study, participants will be asked to complete the following:

• Provide basic personal information (including date of birth, gender, race and ethnicity)
• Provide their medical/ surgical history and perform a medical exam (including but not limited to physical exam, skin type, vital signs, height, weight and urine pregnancy test collection)
• Follow study rules such as avoiding certain medications and treatments
• Allow photographs of the area of skin cancer being treated on the face
• Provide information on any medications, treatments or reactions that started after the study began
• Allow two treatments on the skin cancer area of the face using a light-sensitive cream used in combination with a light source
• Allow clinical documentation of the treatment, such as how well the treatment was tolerated, any skin reaction or side effects
• Allow surgery to remove the skin cancer area from the face for Laboratory testing

To qualify for this trial, participants must:

• be an adult (18 years of age or older)
• give voluntary written consent
• have a recently diagnosed (less than six months from first visit) skin cancer area on the face that meets surgery size requirements
• be willing to follow study instructions and complete study requirements, including not using non-approved lotions and creams on the treatments areas
• (if female) not be pregnant before and during the study and agree to use acceptable forms of birth control
• confirm they are not sensitive to any of the study treatment ingredients

All surgery samples collected from the participants towards the end of the study will be sent to a laboratory for testing. All photographs of the treatment area collected during the study will be used as study data.

All participants have the right to refuse further participation in the study at any time.

Conditions

Facial Cutaneous Squamous Cell Carcinoma in Situ

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

30 participants will be enrolled to this arm

Group Type: EXPERIMENTAL

Aminolevulinic Acid 20% Topical Solution with Blue Light

Intervention Type: 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.

Interventions

Aminolevulinic Acid 20% Topical Solution with Blue Light

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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Levulan® Kerastick®; BLU-U® Blue Light Photodynamic Therapy Illuminator

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Pharmaceutical Industries Limited

INDUSTRY

Sponsor Role: collaborator

The Center for Clinical and Cosmetic Research

OTHER

Sponsor Role: lead

Responsible Party

Mark Steven Nestor, M.D., Ph.D.

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark S Nestor, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Clinical and Cosmetic Research

Locations

Center for Clinical and Cosmetic Research

Aventura, Florida, United States

Countries

United States

Other Identifiers

CCCR 03-2023

Identifier Type: -

Identifier Source: org_study_id