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Completed

NCT Number: NCT03805737

Indoor Daylight Photo Dynamic Therapy for Actinic Keratosis

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.

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amulez and sunlight

Other

Amulez and sun exposure for 2 hours

Amulez and red light treatment

Other

Amulez and red light treatment for 10 minutes

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Norris Cotton Cancer Center

Registry information

Official study title

Indoor Daylight Photo Dynamic Therapy (PDT) for Actinic Keratosis

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 16, 2019
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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