Actinic Keratosis
Conditions
Brief summary
The purpose of this study is to understand better if indoor daylight Photo Dynamic Therapy (PDT) can provide effective lesion clearing versus conventional red lamp light therapy.
Detailed description
Subjects who enroll into this research study, their participation in this study will last up to 6 months. They will be asked to return to the clinic 3-4 times. Subjects will be randomized into one of two study arms: Arm 1 - Indoor Daylight PDT Therapy Arm 2 - FDA Approved Standard Light Therapy Treatment
Interventions
OTHERAmulez and sunlight
Amulez and sun exposure for 2 hours
OTHERAmulez and red light treatment
Amulez and red light treatment for 10 minutes
Sponsors
Norris Cotton Cancer Center
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients with actinic keratosis appearing at the Dermatology Clinic for PDT treatment. * Age ≥ 18 years older.
Exclusion criteria
* Pregnant women or women who are breast-feeding. * Any patients with a condition that makes them not suitable for clinical PDT.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes or clearing of the lesions | Baseline, immediately post-procedure (2 hours) and one and 6 months | The primary aim of this study is to study if indoor daylight PDT can be as effective as regular lamp light PDT. This study can be confounded by the amount of PpIX produced in the lesions as well as the clearing of lesions at one month and six months. |
| Change in the amount of PpIX in the lesion | Baseline and immediately post procedure | Secondary diagnostic study to determine if low-cost cellphone-based skin dosimetry in PDT can facilitate objective measurement of drug levels. |
Countries
United States
Outcome results
None listed