About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Aminolevulinic acid hydrochloride 10% topical gel with Red Light
Treatment groups
Sponsors and collaborators
The Center for Clinical and Cosmetic Research
Lead sponsor
Biofrontera Inc.
Collaborator