Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • aminolevulinic acid HCL (ALA)

    Drug

    Prior to ALA application, the areas will be cleaned with alcohol and debrided gently with prep tape. ALA will then be applied to each of the study lesions and allowed to incubate for 3 hours with occlusion prior to the PDT.

  • BLU-U device model 4170E

    Device

    Participants will be subjected to dose illumination with blue light (BLU-U Model 4170E) at a power fluence of 20 mW/cm2 for a total time of 16 minutes and 40 seconds (1,000 seconds). This will result in a total light delivery dose of 20 J/cm2.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Blue-Light Photodynamic Therapy and SonidegibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Primary efficacy outcome

Primary efficacy outcome measure: the overall response rate (ORR) to the combination therapy in patients, which is the proportion of evaluable study subjects who has complete response (CR) or partial response (PR) to the study treatment as defined in the protocol.

Time frame
From enrollment to day 180
2

Review of AEs likely related to study drug

Primary safety outcome measure: the proportion of evaluable study participants who had a grade 3 or higher adverse event (AE) or any serious adverse event (SAE) that 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. The efficacy outcome measure: the overall response rate (ORR) to the combination therapy in patients, which is the proportion of evaluable study subjects who has complete response (CR) or partial response (PR) to the study treatment.

Time frame
From enrollment to day 180

Secondary outcomes

1

Review of disease progression

The secondary efficacy outcome measures: the proportion of evaluable subjects with progressive disease (PD), and the proportion of evaluable subjects with stable disease (SD). The proportion of evaluable study subjects who have complete histological clearance (CHC). The secondary safety outcome measures: the proportion of evaluable subjects who have AE of any specific grade or any specific type, or any SAE.

Time frame
From enrollment to day 180

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nathalie Zeitouni

Lead sponsor

US Dermatology Partners, Phoenix

Sponsor institution

Source ClinicalTrials.gov
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