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Daylight Photodynamic Therapy for the Treatment of Actinic Keratoses in the Northeast United States (DaylightPDT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02867722
Recruitment Status : Not yet recruiting
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
Information provided by (Responsible Party):
Emily Stamell Ruiz, Brigham and Women's Hospital

Brief Summary:
In this study, daylight PDT will be administered to interested patients at Dana-Farber/Brigham and Women's Cancer Center. Daylight PDT has been shown to be an effective and painless alternative to traditional PDT. Daylight PDT involves application of the photosensitizer in the physician's office followed by exposure to daylight.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Non-melanoma Skin Cancer Drug: aminolevulinic acid HCl Not Applicable

Detailed Description:

The principal investigator will inform patients about the study during their initial consultation at the Mohs and Dermatologic Surgery Center, Dana-Farber/Brigham and Women's Cancer Center at Faulkner Hospital. The patients will be encouraged to make further inquiries about the study if they are interested. Informed consent will be obtained prior to initiating the treatment. If patients are interested in taking part in the study, the investigator will approach them in private to review the consent form and address any study-related questions.

A clinical examination along with photographs will be performed prior to application of the photosensitizer to determine the baseline number of actinic keratoses. The treatment steps were adapted from the daylight-PDT protocol presented in the phase III European multicenter study.9 The treatment will be performed if the temperature conditions are suitable to stay outdoors for 2.5 hours and not under any rainy weather conditions; however, treatment can be performed on overcast days. Suitable weather conditions include an outdoor temperature greater than 50 and between the months of April and November. This is based on a minimum of 8 J cm-2 (although other studies have shown that only 3.5 J cm-2) protoporphyrin IX light dose. A study of various geographic regions found this minimum dose was present in Turin, Italy, which is a similar latitude to Boston, MA.10 Weather conditions will be recorded on the day of treatment and final analysis will be stratified by temperature and weather conditions to evaluate whether this has impacted treatment. Subjects will be advised of the treatment requirements at the time of appointment booking and will be instructed to call the morning of their appointment to confirm that treatment can proceed. Subjects will scrub their faces with warm soapy water to clean and descale the skin and any hypertrophic AKs will be curetted. A chemical sunscreen will be applied to all sun exposed areas followed by one applicator of ALA (Levulan, DUSA pharmaceuticals, Wilmington, MA) to each treatment area. Subjects will be instructed to be exposed to daylight within 30-60 minutes of application and will remain outside in the shade for two and a half hours. Subjects will then remove the ALA and will be instructed to minimize sun exposure and to apply a physical sunscreen (zinc oxide or titanium dioxide) and wear protective clothing for the next 48 hours. This protocol will be repeated after one month unless complete response is documented at the month follow up. Subjects with a history of HSV infection will receive prophylaxis valtrex 500mg daily for 3 days.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Daylight Photodynamic Therapy for the Treatment of Actinic Keratoses in the Northeast United States
Study Start Date : September 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Daylight PDT
Patients will receive daylight-PDT treatment (aminolevulinic acid)
Drug: aminolevulinic acid HCl
Drug will be administered to consented patients
Other Name: Levulan

Primary Outcome Measures :
  1. Number of patients with reduction in the number of actinic keratoses after daylight PDT treatment [ Time Frame: 1 year and 5 years ]

Secondary Outcome Measures :
  1. Number of non-melanoma skin cancers at 1- and 5-years compared to the number of skin [ Time Frame: 1 year and 5 years ]
  2. Number of patients with treatment related adverse events as assessed by CTCAE v4.0 [ Time Frame: 5 years ]
  3. Measure patient satisfaction at 1- and 5- years using the Treatment Satisfaction Questionnaire for Medication [ Time Frame: 1 year and 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients ≥ 18 years referred for the treatment of 5 or more visible or palpable actinic keratoses on one treatment area

Exclusion Criteria:

  • Age less than 18 years of age.
  • Pregnant women.
  • Non-English speaking patients.
  • Treatment of actinic keratoses with other modalities including topical 5-fluorouracil, topical imiquimod, conventional PDT, alpha-hydroxy-acids, and glycolic acids within 2 months
  • Use of retinoids within 1 month
  • Use of the following medications: griseofulvin, thiazide diuretics, sulfonyureas, phenothiazines, sulfonamides, and tetracyclines
  • History of cutaneous photosensitivity, lupus, porphyrias, or any other photosensitizing condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02867722

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Contact: Emily Stamell Ruiz, MD 617-983-4626

Sponsors and Collaborators
Brigham and Women's Hospital
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Principal Investigator: Emily Stamell Ruiz, MD Brigham and Women's Hospital
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Responsible Party: Emily Stamell Ruiz, Physician, Brigham and Women's Hospital Identifier: NCT02867722    
Other Study ID Numbers: 2016P000913
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be aggregated and analyzed
Additional relevant MeSH terms:
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Keratosis, Actinic
Skin Neoplasms
Skin Diseases
Precancerous Conditions
Neoplasms by Site
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents