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| Name | Class |
|---|---|
| Sciton | INDUSTRY |
| Biofrontera Bioscience GmbH | INDUSTRY |
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To provide a treatment of both actinic keratoses and photodamage within one treatment.
To demonstrate that treatment of actinic keratoses and photodamage with a combination of Ameluz and Broad Band Light (BBL) will lead to an improvement in facial precancerous change and signs of photodamage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two PDT treatments | Experimental | Each subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ameluz | Drug | broad band light (BBL) with the use of Ameluz |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of clearance of actinic keratoses | Percentage of actinic keratosis lesion clearance at 1 and 2 months after 2 treatments with the combination of Ameluz and BBL on the face. | 2 months |
| Cosmetic outcomes | Cosmetic outcomes in photoaging of the face evaluated by Subject and Investigator Global Aesthetic Improvement Scale (GAIS) at 1 and 2 months post last PDT. Scale: Very Satisfied (better than expected), Satisfied (as expected), Unsatisfied (worse than expected) | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of clearance of actinic keratoses | Percentage of actinic keratosis lesion clearance at 1 and 2 months after 2 treatments with the combination of Ameluz and BBL on the face using a Visia camera analysis. | 2 months |
| Cosmetic outcomes |
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Inclusion Criteria:
Over 18yrs of age
Willingness to participate in all required study activities and visits
Willingness to sign the informed consent form
Visible and palpable signs of diffuse actinic damage and actinic keratoses of mild to moderate severity located on the face
Significant signs of photoaging, evaluated by investigator, that include any or all the following:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rochester Dermatologic Surgery | Victor | New York | 14564 | United States |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Sciton HEROic |
| Device |
Each subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage. |
|
|
Cosmetic outcomes in photoaging of the face evaluated a Visia camera analysis at 1 and 2 months post last PDT
| 2 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |