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.
Full Title of Study: “Indoor Daylight Photo Dynamic Therapy (PDT) for Actinic Keratosis”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: November 2020
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
- Other: Amulez and sunlight
- Amulez and sun exposure for 2 hours
- Other: Amulez and red light treatment
- Amulez and red light treatment for 10 minutes
Arms, Groups and Cohorts
- Experimental: Indoor Daylight PDT Therapy
- Ameluz will be applied to skin. This will be followed by a 30-minute incubation period. Subsequently, you will be exposed to natural sunlight through a window for 2 hours. Post-treatment assessments will be performed and you will be given instruction on appropriate sun protection methods.
- Active Comparator: FDA Approved Standard Light Therapy Treatment
- Ameluz will be applied to skin. This will be followed by a 30-minute incubation period. Subsequently, you will receive Red Light Treatment for 10 minutes. Post-treatment assessments will be performed and you will be given instruction on appropriate sun protection methods.
Clinical Trial Outcome Measures
- Changes or clearing of the lesions
- Time Frame: 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
- Time Frame: 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.
Participating in This Clinical Trial
- All patients with actinic keratosis appearing at the Dermatology Clinic for PDT treatment.
- Age ≥ 18 years old and ≤ 75 years old.
- Pregnant women or women who are breast-feeding.
- Any patients with a condition that makes them not suitable for clinical PDT.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- Norris Cotton Cancer Center
- Provider of Information About this Clinical Study
- Principal Investigator: Michael S. Chapman, Staff Physican – Dartmouth-Hitchcock Medical Center
- Overall Official(s)
- Michael Shane Chapman, MD, Principal Investigator, Dartmouth-Hitchcock Medical Center
- Overall Contact(s)
- Debra J Rodgers, 603-650-3693, Debra.J.Rodgers@Hitchcock.org
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