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Trial Title:
Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis)
NCT ID:
NCT06577311
Condition:
Cutaneous Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Carcinoma in Situ
Aminolevulinic Acid
Conditions: 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
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Aminolevulinic acid hydrochloride 10% topical gel with Red Light
Description:
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.
Arm group label:
Photodynamic Therapy (using Red light dose)
Other name:
Ameluz ®
Other name:
RhodoLED-XL®
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Center for Clinical and Cosmetic Research
Address:
City:
Aventura
Zip:
33180
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Research Coordinator
Phone:
305-933-6716
Email:
info@centerforclinicalandcosmeticresearch.com
Contact backup:
Last name:
Mark S. Nestor, MD, PhD
Phone:
305-933-6716
Email:
nestormd@admcorp.com
Investigator:
Last name:
Mark S Nestor, M.D., Ph.D.
Email:
Principal Investigator
Start date:
August 14, 2024
Completion date:
August 2025
Lead sponsor:
Agency:
The Center for Clinical and Cosmetic Research
Agency class:
Other
Collaborator:
Agency:
Biofrontera, Inc.
Agency class:
Other
Source:
The Center for Clinical and Cosmetic Research
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06577311
