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| Name | Class |
|---|---|
| Biofrontera Inc. | INDUSTRY |
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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:
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.
In the study, participants will be asked to complete the following:
To qualify for this trial, participants must:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photodynamic Therapy (using Red light dose) | Experimental | 20 participants will be enrolled to this arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminolevulinic acid hydrochloride 10% topical gel with Red Light | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | an average of 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | an average of 12 weeks |
| Size of the lesion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Coordinator | Contact | 305-933-6716 | info@centerforclinicalandcosmeticresearch.com |
| Name | Affiliation | Role |
|---|---|---|
| Mark S Nestor, MD, PhD | Center for Clinical and Cosmetic Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical and Cosmetic Research | Recruiting | Aventura | Florida | 33180 | United States |
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Changes noted in the size of the treated SCCis lesion site, measured by the longest diameter. |
| Up to 16 weeks |
| 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. | Up to 16 weeks |
| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D000081483 | Squamous Intraepithelial Lesions |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| D005782 | Gels |
| D000095742 | Red Light |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D008027 | Light |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D055620 | Optical Phenomena |
| D011827 | Radiation |
| D011840 | Radiation, Nonionizing |
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