DUSA: Cyclic PDT for the Prevention of AK & NMSC in Solid Organ Transplant Recipients

Skin Cancer Clinical Trial

Official title:

Cyclic PDT for the Prevention of Actinic Keratosis and Non Melanoma Skin Cancer in Solid Organ Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03110159
• Other study ID #: PHXB-16-0142-80-15
• Secondary ID: MDS
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 29, 2017
• Est. completion date: February 20, 2024

Study information

• Verified date: March 2024
• Source: Medical Dermatology Specialists
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic
• Non-melanoma Skin Cancer
• Skin Cancer
• Skin Neoplasms
• Sun Damaged Skin

Intervention

Drug:
• Levulan® Kerastick®
Levulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light
• BLU-U Blue Light Photodynamic Therapy
3 hours after Levulan® Kerastick® for Topical Solution is applied blue light illumination of designated area will be performed using the standard FDA approved treatment time of 16 minutes 40 seconds.

Locations

Country	Name	City	State
United States	Medical Dermatology Specialists	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Medical Dermatology Specialists	DUSA Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary prevention of AKs in recently transplanted solid organ recipient	Number of AK will be counted for each site using the photographs of the treatment and the control areas. AKs will be graded by thickness.	3 Years
Primary	Time to occurrence of AKs in recently transplanted solid organ recipient	Time to occurrence of AK will be calculated from the first visit to the development of an AK in the treatment areas and in the control areas.	3 Years
Primary	Primary prevention of NMSC in recently transplanted solid organ recipient	Number of NMSC will be counted for each site using the photographs of the treatment and the control areas. NMSC, including basal cell carcinoma, Bowen's disease and squamous cell carcinoma, will be diagnosis and confirmed histologically by biopsy.	3 Years
Primary	Time to occurrence of NMSC in recently transplanted solid organ recipient	Time to occurrence of NMSC will be calculated from the first visit to the development of an NMSC in the treatment areas and in the control areas.	3 Years
Secondary	Pain control with Levulan-PDT in Solid Organ Transplant Recipient	Pain will be assessed on the 10 point Visual Analogue Scale (VAS), as mild (0-3), moderate (4-7) or severe (8-10). Patients will be asked to rate the pain at the beginning, midway point (approximately 8 minutes later), and at the end of each PDT session.	Day 1, Day 30, Day 180, 12 months, 18 months, 24 months, 30 months, 36 months
Secondary	The number of participants with treatment related adverse events as assessed by the CTCAE v4.0	The number of evaluable study participants who had a grade 3 or higher adverse event (AE) or any serious adverse event that's determined to be at least possibly or probably related to study treatment, or any AE which is at least possibly or probably related to study treatment that causes permanent study discontinuation.	3 Years