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)"
The Center for Clinical and Cosmetic Research
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. I…
Interventions
- Combination ProductAminolevulinic acid hydrochloride 10% topical gel with Red Light
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.
Location
- Center for Clinical and Cosmetic ResearchAventura, Florida