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Study on Blood Vessel Changes in Basal Cell Carcinoma Patients Treated with Bleomycin or Drug Combination

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying changes in blood vessels in a common type of skin cancer known as basal cell carcinoma. The study will explore two non-surgical treatments: electrochemotherapy and photodynamic therapy. Electrochemotherapy involves using electrical pulses to help a drug, in this case, bleomycin, enter cancer cells more effectively. Photodynamic therapy uses a special light along with a drug to kill cancer cells. The main goal of the study is to observe how these treatments affect the small blood vessels in the cancerous area using a technique called optical coherence tomography (OCT), which is a non-invasive imaging method that provides detailed pictures of tissues.

Participants in the study will undergo either electrochemotherapy or photodynamic therapy. Throughout the study, the changes in the blood vessels will be monitored at different depths of the skin before and after the treatment. This will help researchers understand how the treatments work on a microscopic level. Additionally, the study will look at factors like the thickness and density of the cancer, as well as any side effects such as skin darkening, to see how they might influence the treatment outcomes. The quality of life of participants will also be assessed to understand the impact of these treatments on their daily lives.

The study aims to provide valuable insights into the effectiveness of these non-surgical treatments for basal cell carcinoma and to identify any predictors of successful treatment outcomes. By understanding the changes in blood vessels and other factors, researchers hope to improve treatment strategies for this common skin cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination by a dermatological specialist.

    A punch biopsy is performed to confirm the diagnosis of basal cell carcinoma (BCC) on the trunk or extremities, with a diameter less than 2 cm.

  2. Step 2

    Treatment selection

    The treatment involves either electrochemotherapy or photodynamic therapy. The choice of treatment is determined based on specific criteria and the patient's condition.

  3. Step 3

    Bleomycin application

    For patients undergoing electrochemotherapy, bleomycin is applied to the skin. This medication is used to treat the cancerous area and is administered through cutaneous use.

  4. Step 4

    Treatment sessions

    Treatment sessions are scheduled according to the study protocol. The frequency and duration of these sessions depend on the specific treatment plan assigned to the patient.

  5. Step 5

    Monitoring and assessment

    Throughout the trial, the microvascular changes in the BCC are monitored using a technique called dynamic optical coherence tomography (D-OCT).

    Assessments are conducted at various depths (0, 150, 300, and 500 micrometers) to evaluate changes in blood vessels before and after treatment.

  6. Step 6

    Follow-up evaluations

    Follow-up evaluations are performed to assess the clinical outcome and any side effects, such as hyperpigmentation due to bleomycin.

    Quality of life is also evaluated using a specific questionnaire designed for this purpose.

  7. Step 7

    Final assessment

    A final assessment is conducted at the end of the study period to determine the overall effectiveness of the treatment and any long-term effects.

Who can join the trial?

14 criteria

  • Patients must be mentally capable of understanding the information given.
  • Patients must give written informed consent, which means they agree to participate after understanding the study details.
  • Patients must have a clinically diagnosed low-risk **basal cell carcinoma (BCC)** on the trunk and extremities, with a size less than 2 cm. **Basal cell carcinoma** is a type of skin cancer.
  • Participants must be men or women aged at least 18 years.
  • Cases must be reviewed by a dermatological specialist, a doctor who specializes in skin conditions.
  • Patients must be classified as ASA class I-III, which is a system used by the American Society of Anesthesiology to assess the fitness of patients before surgery.
  • Patients must have no prior history of sensitivity or allergies to the chosen treatment drug.
  • Patients must initially agree to have a **punch biopsy** performed at a 1-year follow-up. A **punch biopsy** is a procedure where a small piece of skin is removed for testing.
  • A female of non-childbearing potential is eligible if she:
    • Has had a **hysterectomy**, which is the removal of the uterus.
    • Has had a **bilateral oophorectomy (ovariotomy)**, which is the removal of both ovaries.
    • Has had a **bilateral tubal ligation**, which is a procedure to block the fallopian tubes.
    • Is **post-menopausal**, meaning she has not had a menstrual period for over a year and is over 45 years old, or has specific hormone levels if there is any doubt.
    • A female of childbearing potential is eligible if she has had a negative pregnancy test within 2 weeks before the treatment.
    • Women of childbearing potential and men are eligible if they agree to use adequate contraception from the time they sign the consent form until at least 6 months after the last treatment cycle.

Who cannot join the trial?

3 criteria

  • Patients who have other types of skin cancer besides basal cell carcinoma cannot participate. Basal cell carcinoma is a common type of skin cancer.
  • Patients who are younger than 18 years old or older than 65 years old are not eligible to join the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not allowed to participate.
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Investigated drugs

  • Electrochemotherapy

    is a treatment that combines chemotherapy with electrical pulses. The electrical pulses help the chemotherapy drugs enter cancer cells more effectively. This therapy is used to treat basal cell carcinoma by targeting and destroying cancer cells while minimizing damage to surrounding healthy tissue.

  • Photodynamic Therapy

    involves using a special drug that becomes active when exposed to a specific type of light. This activated drug then kills cancer cells. In the trial, photodynamic therapy is used to treat basal cell carcinoma by applying the drug to the skin and then shining a light on the area to activate the drug, which helps to destroy the cancer cells.

What is already known about the treatment

  • Electrochemotherapy

    This treatment is administered through a combination of electrical pulses and chemotherapy drugs, typically applied directly to the tumor site. It is currently being studied for its effectiveness in treating basal cell carcinoma, a common type of skin cancer. The main therapeutic indication is to target and destroy cancer cells by enhancing the uptake of chemotherapy drugs into the cells. At the molecular level, the electrical pulses temporarily increase cell membrane permeability, allowing the drugs to enter more effectively. Electrochemotherapy is classified under local cancer treatments that combine physical and chemical methods.

  • Photodynamic Therapy

    This therapy involves the application of a photosensitizing agent, which is activated by a specific wavelength of light, usually applied topically or injected. It is being explored for its use in treating basal cell carcinoma. The main therapeutic indication is to selectively destroy cancer cells while minimizing damage to surrounding healthy tissue. The mechanism of action involves the production of reactive oxygen species when the photosensitizer is activated by light, leading to cell death. Photodynamic therapy is classified as a type of phototherapy used in cancer treatment.

Investigated diseases

Basal Cell Carcinoma – Basal cell carcinoma is a type of skin cancer that begins in the basal cells, which are found in the outer layer of the skin. It often appears as a slightly transparent bump on the skin, though it can take other forms. This cancer typically develops on areas of the skin that are exposed to the sun, such as the head and neck. It tends to grow slowly and is unlikely to spread to other parts of the body. Over time, it can cause significant damage to the surrounding tissue if not treated. The progression of basal cell carcinoma is usually localized, affecting only the area where it started.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518228-63-01Estimated enrolment56 patientsSponsorRegion Sjaelland

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