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New treatment option for Cutaneous Squamous Cell Carcinoma
Official title Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis)
ClinicalTrials.gov ID: NCT06577311
What this study is testing
What is Aminolevulinic acid hydrochloride 10% topical gel with Red Light?
Aminolevulinic acid hydrochloride 10% topical gel with Red Light is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for cutaneous squamous cell carcinoma.
Also referred to as Ameluz ®, RhodoLED-XL®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Voluntary written consent required
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aventura, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aventura, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.