Clinical trial NCT06577311: Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis)
Official title: 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)"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
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
Lead sponsor: The Center for Clinical and Cosmetic Research
Sponsor class: OTHER
Collaborators: name: Biofrontera, Inc.
First posted: 2024-08-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with histological clearance of treated SCCis lesion.
timeFrame: an average of 12 weeks
Secondary outcomes:
measure: Number of participants with clinical clearance of treated SCCis lesion
timeFrame: an average of 12 weeks
measure: Size of the lesion
timeFrame: Up to 16 weeks
measure: Local Skin Response Scale
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Aventura
country: United States
facility: Center for Clinical and Cosmetic Research
state: Florida
Study officials:
affiliation: Center for Clinical and Cosmetic Research
name: Mark S Nestor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: