Clinical Trials

Blue-Light Photodynamic Therapy + Sonidegib for Basal Cell Carcinomas

Study Title: Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas
Location: Phoenix, Arizona, United States
ClinicalTrials.gov Identifier: NCT06623201

Summary
This research study is testing combination Blue-light photodynamic therapy and Sonidegib as a possible treatment for people with multiple basal cell carcinoma lesions. Photodynamic therapy uses light along with a drug applied to the skin to kill the cancer cells and cause them to break apart. The light used can cause the skin to feel warm, but does not cause scarring.

Key Details

Condition Studied: Basal Cell Carcinoma (multiple lesions)
Study Type / Phase: Interventional, Phase 1
Recruitment Status: Recruiting

Interventions:
Topical application of aminolevulinic acid (ALA, Levulan) plus PDT using the BLU-U device (blue light illumination)
Sonidegib 200 mg orally daily for 3 months as part of the treatment regimen

Ages Eligible for Study: ≥ 18 years
Gender Eligibility: All genders
Location / Site: Medical Dermatology Specialists, Phoenix, AZ
Principal Investigator: Nathalie Zeitouni, MD, Medical Dermatology Specialists
Contact: Sarah Berman, Medical Dermatology Specialists, (Phone: 602-354-5770 / Email: saberman@usdermpartners.com)

Participants who meet eligibility criteria at baseline will receive Sonidegib 200 mg by mouth every day for 3 months. Participants will undergo three PDT sessions with topical application of ALA at Day 7, Day 30, and Day 90.

The drug applied to the skin before the light treatment is an FDA approved drug called Levulan and has no known side effects.

Eligibility Criteria

Patients will be eligible for inclusion if they meet these study criteria in addition to the others listed on the clinicaltrials.gov website NCT06623201:

Male or females, at least 18 years of age

Diagnosis of BCC with at least 3 nodular lesions that measure 0.5 cm to 5 cm in diameter, located on the head and neck, trunk or extremities.
Diagnosis must be confirmed clinically at baseline with 1-2 lesions having been biopsied no sooner than 2 weeks prior to treatment.
Patients who may have high burden of disease ie large lesions, who are non-surgical candidates or who refuse surgery.

“Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults with Gorlin Syndrome”

TRIAL:

Clinical trial available now for topical gel to prevent basal cell skin cancers (BCCs) in people with Gorlin syndrome.

START DATE:

Ongoing at 43 sites worldwide.

ELIGIBILITY REQUIREMENTS:

These include the following:

Age 18 or over
PTCH1 mutation as the drug works best on these people. Free genetic testing will be done at the screening visit if individual meets requirements noted below.
10 or more BCCs on your face when you are screened. Specialized, high-powered photography equipment is used to identify the lesions.
Oral hedgehog inhibitors (Odomzo (sonidegib) or Erivedge (vismodegib)) must be stopped for 3 months prior to first visit.
Site visits needed: Potential participants will need to go to their chosen clinical trial site for a screening visit. If this is successful, five more in-person site visits will be needed over the course of 12 months. Virtual phone or video visits will also be necessary.
For more details, please go to: clinicaltrials.gov

LOCATIONS:

43 sites worldwide, over half across the United States. See below for a detailed site list with contact information.

EXPENSES:

All costs associated with your travel will be reimbursed fully. This includes air/bus/train fare, gas and tolls, meals, and overnight lodging as necessary. If a care partner is needed, this individuals’ expenses will be covered as well.

The following compensation will be offered at all trial locations.

$500 per each on-site visit
$350 per each remote visit
$750 at last visit upon completion of all obligations such as diary, questionnaires, etc.

If you refer family and friends with Gorlin syndrome, you may be eligible for further financial incentives as well.

BENEFITS:

If an individual completes the trial and the medication is FDA approved, this participant will receive the medication FREE for one year.

With success and FDA approval, we will have a non-surgical, non-invasive preventative therapy for BCCs in the future! YOU will have been a part of creating this opportunity for all adults with Gorlin syndrome.

Free Genetic Testing (if not previously confirmed) for participants to document PTCH1 mutation.

Participate in Trials and Research