Clinical trial NCT03110159: DUSA: Cyclic PDT for the Prevention of AK & NMSC in Solid Organ Transplant Recipients
Official title: Cyclic PDT for the Prevention of Actinic Keratosis and Non Melanoma Skin Cancer in Solid Organ Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Skin Cancer
Non-melanoma Skin Cancer
Sun Damaged Skin
Actinic Keratosis
Keywords: Photodynamic therapy
Prevention
Actinic Keratosis
Skin Cancer
Non-melanoma Skin Cancer
Sun Damaged Skin
Solid Organ Transplant
PDT
Lead sponsor: Medical Dermatology Specialists
Sponsor class: OTHER
Collaborators: name: DUSA Pharmaceuticals, Inc.
First posted: 2017-04-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot, phase 2, prospective, comparative study to evaluate the safety and efficacy of the combination of Levulan® Kerastick® for Topical Solution and blue light illumination using the BLU-U® Blue Light Photodynamic Therapy Illuminator (LevulanPDT).

The study hypothesis is that post solid organ transplantation patients, highly susceptible to non-melanoma skin cancer, can be treated safely and effectively through clinical cyclic application of PDT, lessening morbidity and possible mortality for this immunosuppressed patient population.


Eligibility criteria: Inclusion Criteria:

* Received solid organ transplant
* 3-24 months post-transplant (any number of transplant)
* Time interval of at least 6 days duration where complications such as rejection episodes, viral infections, surgical interventions and therapies with mono or polyclonal antibodies are ruled out by the transplant team.
* No prior history of NMSC in the treatment fields
* No AK/Bowen's disease in the treatment fields within the last 3 months.
* Moderate to severe sun damage
* Be willing to forego other interventions in the treatment fields than the ones approved by the investigator that would interfere with the protocol or evaluation of the study medication

Exclusion Criteria:

* Patients with Fitzpatrick's scale skin type IV-VI
* Cutaneous photosensitivity to wavelengths of 400-450 nm, porphyria or known allergies to porphyrins
* Known sensitivity to any of the components of the Levulan® Kerastick® for Topical Solution
* Prior use of topical or systemic therapies that might interfere with the evaluation of the study medication during the study, within a 3 month washout period from the time of the screening visit
* Unable to return for follow-up visits and tests
* Any condition or situation which in the Investigator's opinion may put the subject at significant risk, could confound the study results, or could interfere significantly with the subject's participation in the study

Primary outcomes:
measure: Primary prevention of AKs in recently transplanted solid organ recipient
timeFrame: 3 Years
measure: Time to occurrence of AKs in recently transplanted solid organ recipient
timeFrame: 3 Years
measure: Primary prevention of NMSC in recently transplanted solid organ recipient
timeFrame: 3 Years
measure: Time to occurrence of NMSC in recently transplanted solid organ recipient
timeFrame: 3 Years
Secondary outcomes:
measure: Pain control with Levulan-PDT in Solid Organ Transplant Recipient
timeFrame: Day 1, Day 30, Day 180, 12 months, 18 months, 24 months, 30 months, 36 months
measure: The number of participants with treatment related adverse events as assessed by the CTCAE v4.0
timeFrame: 3 Years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
state: Arizona
Study officials:
affiliation: Medical Dermatology Specialists
name: Nathalie C. Zeitouni, MD
role: PRINCIPAL_INVESTIGATOR
References: