Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas
ConditionBasal Cell Carcinoma (BCC)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNathalie Zeitouni
About this trial
This research study is testing combination Blue-light photodynamic therapy and Sonidegib as a possible treatment for people with multiple basal cell carcinoma lesions.
Basal cell carcinoma lesions are typically treated by freezing the lesion or surgically removing the lesion. These types of treatment can cause scarring. 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.
Eligibility criteria
Qualifiers
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 1-3 lesions having been biopsied no sooner than 2 weeks prior to treatment.
Patients who may have high burden of disease (i.e., large lesions), who are non-surgical candidates or who refuse surgery.
Disqualifiers
Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation
Intrauterine device (IUD); intrauterine hormone-releasing system
Bilateral tubal ligation;
Vasectomized partner (provided that the vasectomized partner is the sole sexual partner of the WOCBP study subject);
Trial design
Treatments tested in this trial
- aminolevulinic acid HCL (ALA)
- BLU-U device model 4170E
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Nathalie Zeitouni
Lead sponsor
US Dermatology Partners, Phoenix
Sponsor institution
Source ClinicalTrials.gov