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| Name | Class |
|---|---|
| Sun Pharmaceutical Industries Limited | 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 cream used in combination with a light source.
The main questions this trial aims to answer are:
Participants who qualify will be asked to complete 12 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 (Blue light dose 10 J/cm2 at 10 mW/cm2) | Experimental | 30 participants will be enrolled to this arm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminolevulinic Acid 20% Topical Solution with Blue Light | Combination Product | Participants will have their facial isSCC prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by blue light therapy administered for 16 minutes and 40 seconds to deliver the total desired light dose to the isSCC lesion. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Histological Clearance of treated isSCC lesion | Histological clearance is defined as the absence of detectable evidence of isSCC tumor cell nests by the central pathology reports | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with clinical clearance of treated isSCC 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. | through treatment completion, an average of 12 weeks |
| Local Skin Response Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Aventura | Florida | 33180 | United States |
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Observations and changes noted in the aesthetic appearance (Erythema, Flaking/ Scaling, Crusting, Swelling, Vesiculation/ Pustulation, Erosion/ Ulceration) of the treated isSCC lesion will each be graded on a scale of 0 to 4, with 0 as no presence and 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 |
| D012996 | Solutions |
| D000095743 | Blue Light |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| 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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