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.
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
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
Single group
Aminolevulinic acid hydrochloride 10% topical gel with Red Light
Combination productParticipants 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.
Number of participants with histological clearance of treated SCCis lesion.
Histological clearance is defined as the absence of detectable evidence of SCCis tumor cell nests by the central pathology reports
Number of participants with clinical clearance of treated SCCis lesion
Complete Clinical Clearance will be measured by the Investigator and is defined as when there is no clinically visible lesion remaining at the site
Size of the lesion
Changes noted in the size of the treated SCCis lesion site, measured by the longest diameter.
Local Skin Response Scale
Observations and changes noted in the aesthetic appearance (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/ Pustulation, Erosion/ Ulceration) of thetreated isSCC lesion will each be graded on a scale of 0 to 4, with 0 as no presenceand 4 as a severe outcome.
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The Center for Clinical and Cosmetic Research
Lead sponsor
Biofrontera Inc.
Collaborator
