- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06159842
Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC)
An Investigator Initiated Study to Evaluate the Safety and Efficacy of Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick®) (ALA) + Blue Light in the Treatment of Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC)
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Clinical Coordinator
- Phone Number: 305-933-6716
- Email: info@centerforclinicalandcosmeticresearch.com
Study Locations
-
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Florida
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Aventura, Florida, United States, 33180
- Recruiting
- Center for Clinical and Cosmetic Research
-
Contact:
- Clinical Research Coordinator
- Phone Number: 305-933-6716
- Email: info@centerforclinicalandcosmeticresearch.com
-
Contact:
- Mark S. Nestor, MD, PhD
- Phone Number: 305-933-6716
- Email: nestormd@admcorp.com
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Principal Investigator:
- Mark S Nestor, M.D., Ph.D.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Photodynamic Therapy (Blue light dose 10 J/cm2 at 10 mW/cm2)
20 participants will be enrolled to this arm
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with Histological Clearance of treated isSCC lesion
Time Frame: Up to 16 weeks
|
Histological clearance is defined as the absence of detectable evidence of isSCC tumor cell nests by the central pathology reports
|
Up to 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with clinical clearance of treated isSCC lesion
Time Frame: through treatment completion, an average of 12 weeks
|
Complete Clinical Clearance will be measured by the Investigator and is defined as when there is no clinically visible lesion remaining at the site.
|
through treatment completion, an average of 12 weeks
|
Local Skin Response Scale
Time Frame: up to 16 weeks
|
Observations and changes noted in the aesthetic appearance (Erythema, Flaking/ Scaling, Crusting, Swelling, Vesiculation/ Pustulation, Erosion/ Ulceration) of the treated isSCC lesion will each be graded on a scale of 0 to 4, with 0 as no presence and 4 as a severe outcome.
|
up to 16 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mark S Nestor, MD, PhD, Center for Clinical and Cosmetic Research
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCCR 03-2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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