Actinic Keratoses
Conditions
Keywords
Actinic Keratoses
Brief summary
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.
Detailed description
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
Interventions
DRUGFluorouracil
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.
PROCEDUREPhotodynamic therapy
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.
PROCEDURECarac in combination with PDT
Sponsors
Sanofi
Skin Laser & Surgery Specialists
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Males/females,, aged 40-70 * Must have 5 or more documented facial/anterior scalp actinic keratoses * Read, understood, and signed informed consent form * Willing and able to comply with all follow-up requirements
Exclusion criteria
* Previous treatment of facial keratoses with any modality of treatment within 3 months of study enrollment * Contraindications to the use of either Carac and/or PDT treatment * Exclusion of biopsy proven skin cancer in the area * Active infections or dermatitis in the treatment area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Actinic Keratoses | Outcomes are assessed at 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Photographic Improvement of Actinic Keratoses | Outcomes are assessed at 3 months | 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. |
Outcome results
None listed