Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses
| Status: | Recruiting |
|---|---|
| Conditions: | Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/28/2018 |
| Start Date: | April 2014 |
| End Date: | December 2018 |
| Contact: | Lisa Rittwage, BSN, RN |
| Email: | rittwal@ccf.org |
| Phone: | 216-444-4659 |
Simultaneous Incubation/Illumination Versus Short Aminolevulinate Preincubation for Painless Photodynamic Therapy of Actinic Keratoses
This study is being done to compare a new, continuous illumination regimen of ALA-PDT
(Aminolevulinate-Photodynamic Therapy) to a conventional regimen for treatment of actinic
keratoses. The hypothesis is that the continuous illumination approach will be less painful,
but equally efficacious, as the old regimen.
(Aminolevulinate-Photodynamic Therapy) to a conventional regimen for treatment of actinic
keratoses. The hypothesis is that the continuous illumination approach will be less painful,
but equally efficacious, as the old regimen.
This study is being done to compare two modified versions of the standard ALA-PDT
(Aminolevulinate-Photodynamic Therapy) treatment of actinic keratoses. The treatment has been
modified in one of two ways, either: (#1) a shortened incubation time (1 hr), or (#2) light
exposure that begins immediately after application of the Levulan. We hypothesize that this
will yield a therapeutic efficacy equivalent to the standard ALA-PDT regimen, but will cause
less pain during the light exposure. The study employs a bilateral design in which the left
versus right sides of the treatment area are compared on the same patient.
(Aminolevulinate-Photodynamic Therapy) treatment of actinic keratoses. The treatment has been
modified in one of two ways, either: (#1) a shortened incubation time (1 hr), or (#2) light
exposure that begins immediately after application of the Levulan. We hypothesize that this
will yield a therapeutic efficacy equivalent to the standard ALA-PDT regimen, but will cause
less pain during the light exposure. The study employs a bilateral design in which the left
versus right sides of the treatment area are compared on the same patient.
Inclusion Criteria:
- Males or females, at least 18 years of age
- Non-hyperkeratotic actinic keratoses, at least 6 in number (3 on each side of scalp,
face or upper extremities)
Exclusion Criteria:
- patient is currently pregnant or are planning to conceive during the course of the
study period
- patient is using topical therapy or other treatment for these actinic keratoses
- patient has a known hypersensitivity to 5-aminolevulinic acid
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