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Efficacy and Safety of Photodynamic Therapy with 5‑Aminolevulinic Acid in Immunosuppressed Patients with Actinic Keratosis and Superficial Basal Cell Carcinoma

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

The study focuses on people whose immune system is weakened (immunosuppressed) and who have skin lesions caused by long‑term sun exposure, including rough, scaly patches known as actinic keratosis, a mild form of skin cancer called basal cell carcinoma, and a more aggressive type referred to as cutaneous squamous cell carcinoma. The treatment uses a specially formulated gel that contains the substance 5-aminolevulinic acid, identified in the trial by the code name BF-200 ALA (commercially Ameluz). After the gel is applied to the affected skin area, a controlled light source is used in a process called photodynamic therapy to activate the medication and target the abnormal cells.

The purpose of the trial is to evaluate how well the treatment works and how safe it is in the described patient group compared with people who are not immunosuppressed. Participants receive the gel, wait briefly for it to be absorbed, and then undergo the light‑based procedure. Follow‑up visits are scheduled a few months later to check whether the lesions have disappeared completely and to monitor for any new skin changes over the next year.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial enrollment and baseline assessment

    You attend the first study visit after you have joined the trial.

    The study staff records your medical history, confirms that you have a weakened immune system and skin lesions such as actinic keratosis or basal cell carcinoma, and documents the size and location of each lesion.

    Any required laboratory tests or imaging are performed to establish a baseline for later comparison.

  2. Step 2

    Application of ameluz gel and photodynamic therapy

    You receive a single dose of ameluz 78 mg/g gel, which contains the active substance 5-aminolevulinic acid.

    The prescribed amount is 6 g of gel, which is applied directly to the skin lesions by the study staff.

    After the gel is applied, a special light source is used to activate the medication; this process is called photodynamic therapy.

    The light exposure is performed according to the study protocol and is completed in the same visit.

  3. Step 3

    Short‑term post‑treatment monitoring

    Immediately after the light exposure you are observed for a short period to ensure that no immediate adverse reactions occur.

    Any discomfort or skin reactions are recorded by the study staff.

  4. Step 4

    First follow‑up visit (3 months)

    Approximately three months after the treatment you return for a follow‑up assessment.

    The study team checks whether the treated lesions have completely disappeared, which is the primary measure of success.

    Any side effects that have appeared since the treatment are also documented.

  5. Step 5

    Later follow‑up visits (6–12 months)

    Between six and twelve months after treatment you attend additional visits.

    These visits evaluate whether any lesions have returned, whether new actinic keratoses or non‑melanoma skin cancers have developed, and overall safety of the treatment.

Who can join the trial?

5 criteria

  • Be at least 18 years old.
  • Have a weakened immune system (immunosuppressed) because of an organ transplant or a blood disease such as chronic lymphocytic leukemia or multiple myeloma.
  • Have a doctor‑confirmed diagnosis of actinic keratosis (small, rough skin spots that can become cancer) that are grade I or II, with 3 to 9 spots, and/or basal cell carcinoma (a common type of skin cancer) with 1 to 3 lesions that are between 0.5 and 2 cm in size, located on the face, scalp, neck, trunk, or arms/legs.
  • Be able to understand the study information and sign the permission form (informed consent).
  • Be able to return for check‑up visits at 3 months, 6 months, and 12 months after treatment (follow‑up visits).

Who cannot join the trial?

7 criteria

  • Known allergy to 5‑ALA, peanuts, soy, or any part of the study medication (BF‑200 ALA).
  • Having porphyria (a rare condition that makes the skin very sensitive to light) or any other disorder that makes the skin react badly to light.
  • Being pregnant or breastfeeding.
  • Using any cream, gel, or other skin‑applied medication on the area that will be treated within the past 12 weeks or during the study.
  • Having had more than five previous treatments on the same skin area, because that can make the spots hard to treat.
  • Taking part in another clinical study in the last 30 days.
  • Using medicines or substances that can cause a reaction when exposed to light (phototoxic or photoallergic) in the past 8 weeks.
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Investigated drugs

Ameluz is a clear gel that contains a substance called 5‑aminolevulinic acid. When the gel is applied to the skin, the active ingredient is taken up by abnormal skin cells, such as those seen in actinic keratoses and superficial basal cell carcinoma. This helps prepare the targeted cells for a later step in the treatment, making them more sensitive to light. Photodynamic therapy (PDT) is the procedure used with Ameluz. After the gel is applied and allowed to sit on the skin for a short time, a special light source is shone onto the treated area. The light activates the 5‑aminolevulinic acid, causing a reaction that destroys the abnormal cells while sparing most of the surrounding healthy tissue. This combined approach is being studied to see how well it works and how safe it is, especially in patients whose immune systems are suppressed.

What is already known about the treatment

Ameluz 78 mg/g gel - This gel is applied directly to the skin and left on for a short time before being exposed to a special light source, a process called photodynamic therapy. 5‑Aminolevulinic acid, the active ingredient, is already approved and widely studied for treating surface skin cancers and precancerous spots. It works by turning into a light‑sensitive compound inside abnormal skin cells, which then destroys those cells when illuminated. The medication belongs to the class of photosensitizing agents used for topical treatment of actinic keratosis, basal cell carcinoma, and similar skin lesions.

Investigated diseases

  • Actinic keratosis

    A rough, scaly patch that develops on skin exposed to long‑term sunlight. It starts as a small, often painless lesion that may become thicker over months. The area can feel rough when stroked and may appear red or brown. If the lesion continues to grow, the cells become more abnormal. In some cases, the patch can evolve into a skin cancer if left untreated.

  • Cutaneous squamous cell carcinoma

    A malignant tumor that arises from the flat cells in the outer layer of the skin. It usually appears as a firm, red nodule or a scaly ulcer that enlarges slowly. The growth can spread locally, invading deeper skin layers. Over time, the tumor may extend into surrounding tissue. It can also develop new lesions nearby as the disease progresses.

  • Basal cell carcinoma

    A common skin cancer that originates from the basal cells at the bottom of the epidermis. It often looks like a pearly bump, a flat scar‑like patch, or a small ulcer. The lesion typically grows slowly but can become larger and bleed. As it expands, it may infiltrate nearby skin and soft tissue. New lesions may appear in the same area as the disease advances.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2026-526649-85-00Estimated enrolment120 patients

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