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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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To demonstrate if Carac treatment after PDT treatment of actinic keratoses leads to superior clinical improvement when compared to Carac or PDT treatment alone. This will be done by manual counts and through photography.
Carac has been shown to be highly effective for the treatment of actinic keratoses. Photodynamic Therapy (PDT) has also been shown to be highly effective for the treatment of actinic keratoses. Both treatments are FDA approved. The mechanism of action of each therapy is different. In general a more vigorous, but less cosmetically acceptable appearance is seen after Carac treatment as compared to PDT treatment. The purposes of this study are to determine 1) If the use of Carac, followed by PDT treatment, of actinic keratoses leads to an enhanced clinical improvement as compared to PDT treatment alone; 2) If the cosmetic appearance of the skin during Carac is improved with PDT pre-treatment; 3) Evaluate histologic changes induced by combined Carac/PDT treatment as compared to Carac treatment alone and PDT treatment alone.;4) Evaluate safety of treatments in terms of potential for infection and scarring
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Carac |
|
| 2 | Active Comparator | Photodynamic Therapy |
|
| 3 | Active Comparator | Carac combined with Photodynamic Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorouracil | Drug | Carac (fluorouracil) Cream, 0.5% is used by adults to treat skin conditions on the face and front part of the scalp called solar keratosis or actinic keratosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Actinic Keratoses | The objective of this study is to demonstrate if Carac treatment after PDT treatment of actinic keratoses leads to superior clinical improvement when compared to Carac or PDT treatment alone based on a manual lesion count. | Outcomes are assessed at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Photographic Improvement of Actinic Keratoses | The objective of this study is to demonstrate if Carac treatment after PDT treatment of actinic keratoses leads to superior clinical improvement when compared to Carac or PDT treatment alone based on a photographic improvement using the Actinic Keratosis-Field Assessment Scale. | Outcomes are assessed at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|
| D005472 | Fluorouracil |
| D010778 | Photochemotherapy |
| C008848 | 1-phenyl-3,3-dimethyltriazene |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Photodynamic therapy | Procedure | Photodynamic therapy (PDT) is a procedure that uses a photosensitizing drug to apply light therapy selectively to target pre-skin cancer, acne and sun damage. |
|
| Carac in combination with PDT | Procedure |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D006571 |
| Heterocyclic Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |