Cutaneous Squamous Cell Carcinoma
Conditions
Keywords
skin cancer, facial skin cancer, Squamous Cell Carcinoma, Squamous Cell Carcinoma in Situ, Cutaneous Squamous Cell Carcinoma in Situ, Facial Cutaneous Squamous Cell Carcinoma in Situ, SCCis
Brief 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.
Detailed 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 using a light-sensitive cream used in combination with a light source * Allow clinical documentation of the treatment, such as how well the treatment was tolerated, any skin reaction or side effects * Allow surgery to remove the skin cancer area from the face for Laboratory testing To qualify for this trial, participants must: * be an adult (18 years of age or older) * give voluntary written consent * have a recently diagnosed (less than six months from first visit) skin cancer area on the face that meets surgery size requirements * be willing to follow study instructions and complete study requirements, including not using non-approved lotions and creams on the treatments areas * allow photographs of the area of skin cancer being treated on the face * (if female) not be pregnant before and during the study and agree to use acceptable forms of birth control * confirm they are not sensitive to any of the study treatment ingredients All surgery samples collected from the participants towards the end of the study will be sent to a laboratory for testing. All photographs of the treatment area collected during the study will be used as study data. All participants have the right to refuse further participation in the study at any time.
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.
Sponsors
Biofrontera Inc.
The Center for Clinical and Cosmetic Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with histological clearance of treated SCCis lesion. | an average of 12 weeks | Histological clearance is defined as the absence of detectable evidence of SCCis tumor cell nests by the central pathology reports |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with clinical clearance of treated SCCis lesion | an average of 12 weeks | 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 | Up to 16 weeks | Changes noted in the size of the treated SCCis lesion site, measured by the longest diameter. |
| Local Skin Response Scale | Up to 16 weeks | 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. |
Countries
United States
Contacts
Primary ContactClinical Coordinator
Outcome results
None listed