NCT06577311 · The Center for Clinical and Cosmetic Research
Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis)
What this study is 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Aventura, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 29, 2024 · Source of record for eligibility and locations