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

The Center for Clinical and Cosmetic Research

Status and phase

Enrolling

Phase 2

Conditions

Cutaneous Squamous Cell Carcinoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06577311

CCCR 01-2024

Details and patient eligibility

About

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.

Full 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 symptom-directed physical exam, skin type, vital signs, height, weight and urine pregnancy test collection)
Follow study rules such as avoiding certain medications and treatments
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
allow photographs of the area of skin cancer being treated on the face
(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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion 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

Exclusion criteria

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.