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Completed

NCT Number: NCT04552990

Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma

The purpose of this study is to find out whether injecting ALA into the skin with a jet-injection device and activating the drug with light is a safe treatment that causes few or mild side effects in people with basal cell carcinoma.

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Key information

Conditions

BCC BCC - Basal Cell Carcinoma Basal Cell Cancer Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Nodular Basal Cell Carcinoma Superficial Basal Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects who meet all of the following criteria are eligible to participate in this study

  • Histologically-verified, previously untreated low-risk mixed superficial and nodular BCC(s) or nodular BCC(s) < 1 cm in diameter on scalp, extremities, or trunk.
  • ≥ 18 years of age
  • Owner of a smartphone (Android or iPhone). Patients without a working smartphone will not be considered eligible for this study.
  • Being able to download application on their phone
  • Being able to take pictures of their treated BCC(s) (with or without assistance)
  • Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment. (Female subjects are considered of childbearing potential unless they have been hysterectomized or have undergone tubal ligation or have been post-menopausal for at least one year prior to the first visit)
  • Legally competent, able to give verbal and written informed consent
  • Subject in good general health and willing to participate comply with protocol requirements.
  • Superficial and nodular BCC(s)

Exclusion criteria

Subjects meeting any one of the following criteria are not eligible to participate in this study

  • High-risk BCC(s) (H area, >1 cm in M area, or >2 cm in L area)
  • BCC(s) subtype morpheaform
  • Diagnosed with gorlin syndrome
  • Receiving immunosuppressive medication
  • Subjects with a known allergy to ALA
  • Individuals with other interfering skin diseases in the area of treatment
  • Subjects with a tattoo in the treatment area which may interfere with or confound the evaluation of the study
  • Subjects with a history of keloids which is deemed clinically relevant in the opinion of the investigator
  • Lactating or pregnant women
  • Patient who are taking prescription pain medications or can not stop OTC pain medications.

Treatment and study plan

Jet injection of ALA

Drug

The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap).

Surgical excision

Procedure

In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted).

Illumination

Procedure

For patients 5-16,after 3h incubation (+/- 30 min), the tumor will be illuminated with red light corresponding to a dose of 75 J/cm2 570- 670 nm or equivalent dose of narrowband red light. The intervention will be repeated at after 14 days in patient 5-16. If the wound is not healed at two weeks, the treatment may be postponed to allow healing (patient 5-16).

Incubation

Other

After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).

Primary outcomes

  1. Clinical Evaluation of Local Skin Responses on Day 0

    Time frame: Baseline (Day 0)

    Clinical evaluation of local skin responses will be performed at Day 0 (PDT treatment #1). The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity).

  2. Clinical Evaluation of Local Skin Responses on Day 3

    Time frame: Day 3

    Clinical evaluation of local skin responses will be performed at Day 3. The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity).

  3. Clinical Evaluation of Local Skin Responses on Day 14

    Time frame: Day 14

    Clinical evaluation of local skin responses will be performed at Day 14 (PDT treatment #2). The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity).

  4. Clinical Evaluation of Local Skin Responses on Day 17

    Time frame: Day 17

    Clinical evaluation of local skin responses will be performed at Day 17. The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity).

  5. Clinical Evaluation of Local Skin Responses 3 Months Post Treatment

    Time frame: 3 months after treatment

    Clinical evaluation of local skin responses will be performed 3 months post treatment. The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity).

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Jet-Injection Assisted Photodynamic Therapy for Basal Cell Carcinoma

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 17, 2020
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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