Alacare (5-Aminolevulinic Acid)

What Is Alacare and What Is It Used For?

Alacare belongs to a class of medicines known as photosensitizing agents. It is manufactured by medac GmbH and is approved in the European Union, Australia, and several other countries for the treatment of mild actinic keratoses (AKs). Actinic keratoses are rough, scaly patches of skin that develop after years of chronic ultraviolet (UV) exposure from sunlight. These lesions are classified as pre-cancerous because, if left untreated, a proportion of them can progress to squamous cell carcinoma, a form of skin cancer.

The medicine works through a process called photodynamic therapy (PDT), which combines a light-sensitive chemical (the photosensitizer) with a specific wavelength of light to selectively destroy abnormal cells. The active ingredient, 5-aminolevulinic acid (ALA), is a naturally occurring compound in the human body that plays a key role in the haem biosynthesis pathway. When applied to the skin via the Alacare plaster, ALA is absorbed into the epidermal cells and taken up particularly efficiently by dysplastic (pre-cancerous) cells.

Once inside the cells, ALA is enzymatically converted into protoporphyrin IX (PpIX), a potent photosensitizer. The reason this process is selective is that dysplastic cells have reduced levels of the enzyme ferrochelatase, which normally converts PpIX into haem. As a result, PpIX accumulates to much higher concentrations in abnormal cells compared to healthy surrounding tissue. When the treated area is subsequently exposed to red light at a wavelength of 630 nm, the accumulated PpIX absorbs the light energy and reacts with molecular oxygen to generate reactive oxygen species (ROS), including singlet oxygen. These highly reactive molecules damage cellular membranes, proteins, and DNA, triggering apoptosis (programmed cell death) and necrosis of the targeted abnormal cells.

Alacare is specifically indicated for the treatment of mild actinic keratoses with a maximum diameter of 1.8 cm located on hairless areas of the face and scalp. Each treatment session can address up to 6 lesions simultaneously. The treatment is a single-use procedure, meaning each plaster is used only once, and the clinical response is assessed at a follow-up appointment 3 months after treatment. If the lesion has not cleared completely at the 3-month assessment, alternative treatment approaches should be discussed with the treating dermatologist.

Clinical trials have demonstrated that Alacare PDT achieves complete clearance rates of approximately 82–89% for mild actinic keratoses at 3 months post-treatment. The treatment offers several advantages over other AK therapies: it is well-tolerated, produces excellent cosmetic outcomes with minimal scarring, and the plaster format ensures precise, consistent dosing of the active ingredient directly to each lesion.

What Should You Know Before Using Alacare?

Contraindications

There are several important situations in which Alacare must not be used. Your dermatologist will assess these before prescribing the treatment. Alacare is contraindicated in the following circumstances:

• Hypersensitivity to 5-aminolevulinic acid, porphyrins, or any of the excipients in the plaster formulation.
• Porphyria of any type. Porphyrias are a group of rare inherited or acquired metabolic disorders affecting the haem biosynthesis pathway. Since ALA directly enters this pathway, administering additional ALA to patients with porphyria could trigger acute porphyric attacks with potentially severe consequences including abdominal pain, neurological symptoms, and photosensitivity reactions.
• Photodermatoses or any skin condition caused or aggravated by exposure to light, such as polymorphous light eruption, solar urticaria, or chronic actinic dermatitis.
• Known photosensitivity to sunlight or artificial light sources.

Warnings and Precautions

Before and during treatment with Alacare, several important precautions should be observed to ensure patient safety and optimal treatment outcomes:

• Professional administration only: Alacare PDT must only be administered by a nurse or other healthcare professional who has been trained in photodynamic therapy procedures, under the supervision of a physician. Self-administration at home is not appropriate.
• Sun avoidance: Treated areas and the surrounding skin must be protected from sunlight and strong artificial light for at least 48 hours after treatment. The photosensitizing effect of protoporphyrin IX can persist for up to 48 hours, and sun exposure during this period could cause severe phototoxic skin reactions with intense burning, blistering, and pain.
• Lesion assessment: The clinical response should be evaluated at 3 months after treatment. If the treated lesion is not completely cleared at this follow-up, alternative therapeutic approaches should be considered. Alacare is intended as a single-treatment modality for each lesion.
• Avoid mucous membranes and eyes: The plaster must not be applied to the eyes, inside the nostrils, inside the ears, on the lips, or on any mucosal surfaces. If accidental contact occurs, the area should be thoroughly rinsed with water.
• Immunosuppressed patients: There is limited experience with Alacare PDT in immunocompromised patients (e.g., organ transplant recipients, patients on immunosuppressive therapy). These patients may have an altered response to treatment and should be monitored more closely.
• Thick or hyperkeratotic lesions: Alacare is indicated for mild actinic keratoses only. Thick, heavily crusted, or hyperkeratotic lesions may not respond adequately because the ALA cannot penetrate sufficiently deep into the lesion.

Pregnancy and Breastfeeding

The safety of Alacare during pregnancy has not been adequately studied. There are no controlled clinical trial data from the use of 5-aminolevulinic acid in pregnant women, and animal studies are insufficient to determine the potential effects on pregnancy, embryo-fetal development, parturition, or postnatal development. Therefore, Alacare should not be used during pregnancy unless the treating physician determines that the potential benefit clearly outweighs the potential risk to the developing fetus. In most clinical scenarios, treatment of actinic keratoses can be safely postponed until after delivery.

It is currently unknown whether 5-aminolevulinic acid or its metabolites are excreted in human breast milk. As a precautionary measure, breastfeeding should be discontinued for 48 hours after application of Alacare. Breast milk expressed during this 48-hour period should be discarded. There are no specific data available regarding the effects of Alacare on human fertility.

How Does Alacare Interact with Other Drugs?

The primary concern with drug interactions involving Alacare relates to additive photosensitivity. Since the treatment relies on light-activated destruction of cells, any concurrent medications that increase the skin's sensitivity to light can enhance the risk and severity of phototoxic reactions. This could lead to more extensive tissue damage, greater pain during illumination, and prolonged or more severe post-treatment skin reactions.

If you are taking any photosensitizing medications, inform your dermatologist before the procedure. In many cases, these medications can be temporarily withheld for 24 hours before and 24 hours after the Alacare PDT session, though this should always be done under medical guidance and only if it is safe to temporarily interrupt the medication.

Major Interactions

The following classes of drugs are known to cause significant photosensitization and should ideally be avoided around the time of Alacare treatment:

Minor Interactions

Some medications and topical products may have minor interactions with Alacare that are less clinically significant but should still be mentioned to your healthcare provider:

• Topical retinoids (tretinoin, adapalene): May increase skin sensitivity and irritation at the treatment site. Discontinue topical retinoids on the treatment area for at least 1 week before PDT.
• Chemical peels or laser treatments: Avoid concurrent use of other skin treatments on the same area. Allow adequate healing time between procedures (typically 2–4 weeks).
• Topical corticosteroids: May theoretically reduce the immune-mediated component of the PDT response, though clinical significance is uncertain.

What Is the Correct Dosage of Alacare?

Adults

The treatment procedure is carried out entirely in a clinical setting by trained healthcare professionals. Prior to applying the plaster, the treatment area is cleaned and any crusts or scales on the lesion surface may be gently removed (debrided) to enhance penetration of the active ingredient. The release liner is peeled away from the plaster, and the adhesive side is placed directly onto the actinic keratosis, ensuring the medicated matrix is in full contact with the lesion.

After 4 hours of occlusion, during which the 5-aminolevulinic acid is absorbed and metabolized to protoporphyrin IX within the dysplastic cells, the plaster is carefully removed. The treated area is then immediately exposed to narrow-band red light using an approved medical light source. The illumination delivers a precisely calibrated total light dose of 37 J/cm² over a period of approximately 10 minutes. Both the patient and the treating clinician should wear appropriate eye protection during the illumination phase.

Children

Elderly

Missed Dose

The concept of a missed dose does not apply to Alacare in the traditional sense, as it is a single-use, healthcare-professional-administered treatment. If a scheduled treatment appointment is missed, the patient should contact their dermatologist to reschedule. There is no ongoing dosing regimen to maintain.

If the plaster detaches prematurely during the 4-hour occlusion period, the healthcare team should assess whether sufficient exposure has occurred. If the plaster has been in place for less than approximately 3 hours, the treatment may need to be rescheduled with a new plaster, as inadequate ALA absorption could compromise efficacy.

Overdose

Overdose with Alacare in the conventional pharmacological sense is highly unlikely given its topical, healthcare-administered route of delivery. The plasters contain a fixed dose, and systemic absorption of 5-aminolevulinic acid from the cutaneous route is minimal. No cases of systemic toxicity from Alacare overdose have been reported.

However, if the plaster is left on for significantly longer than the recommended 4 hours, this could lead to excessive accumulation of protoporphyrin IX in the skin, potentially resulting in more severe pain and tissue damage during the illumination phase. If an extended application time occurs, the treating clinician should consider whether to proceed with illumination or postpone treatment. In the event of accidental ingestion, standard supportive measures should be applied, and the patient must be strictly protected from light exposure for at least 48 hours.

What Are the Side Effects of Alacare?

Like all medicines, Alacare can cause side effects, although not everybody gets them. The vast majority of side effects associated with Alacare PDT are local reactions at the treatment site that occur as a direct consequence of the photodynamic process. These are expected pharmacological effects of the treatment rather than true adverse reactions, and they indicate that the therapy is working by destroying the targeted abnormal cells. Side effects may occur during plaster application, during the red light illumination, and/or in the days and weeks following treatment.

The illumination phase is typically the most uncomfortable part of the procedure for patients. Pain and burning sensations during light exposure are very common and can range from mild discomfort to moderate-to-severe pain. Healthcare teams experienced in PDT may offer cooling measures or pain management strategies during this phase. Post-treatment skin reactions generally peak within the first 24–72 hours and gradually resolve over the following 1–2 weeks, though some effects can persist or appear up to 6 weeks after treatment.

It is important to understand that the local skin reactions listed above are largely expected consequences of the photodynamic process and do not necessarily indicate an adverse drug reaction in the traditional sense. The destruction of abnormal cells by reactive oxygen species inevitably produces some degree of inflammation, redness, and discomfort. In most cases, these reactions resolve spontaneously without specific intervention. However, if reactions are severe, persistent, or accompanied by signs of infection (increasing pain, pus, spreading redness, fever), patients should contact their healthcare provider promptly.

How Should You Store Alacare?

Proper storage of Alacare is essential to maintain the stability and efficacy of the active ingredient, 5-aminolevulinic acid. ALA is a light-sensitive compound that can degrade when exposed to light or excessive heat, which would reduce the concentration of the active ingredient and potentially compromise treatment effectiveness. The following storage guidelines should be observed:

• Temperature: Store at or below 25°C (77°F). Do not freeze. Do not store in direct sunlight or near heat sources such as radiators.
• Light protection: Keep the plasters in their original light-protective sachets until immediately before use. The individual aluminium sachets are specifically designed to shield the medicated plasters from light degradation.
• After opening: Once a sachet has been opened, the plaster should be used promptly. If not used immediately, it may be stored for a maximum of 3 months from the date of first opening, provided it is kept in a cool, dark place.
• Expiry date: Do not use Alacare after the expiry date (EXP) stated on the outer carton and individual sachet. The expiry date refers to the last day of the stated month.
• Keep out of reach of children: Store in a secure location inaccessible to children. The plasters are not toys and should not be handled by children.
• Disposal: Do not dispose of unused plasters via household waste or wastewater. Return unused or expired plasters to a pharmacy for appropriate disposal in accordance with local regulations.

In clinical practice, Alacare is typically stored and dispensed by the dermatology clinic or hospital pharmacy rather than by the patient at home. Healthcare facilities should ensure that stock is stored according to these requirements and that stock rotation (first-in, first-out) is practiced to avoid using expired products. The plasters are supplied in pack sizes of 4 or 8 medicated plasters.

What Does Alacare Contain?

Alacare is formulated as a self-adhesive transdermal plaster specifically designed for cutaneous drug delivery to actinic keratosis lesions. Understanding the composition of the product can be helpful for identifying potential allergens, particularly in patients with known sensitivities to adhesives or other plaster components.

Active Ingredient

The active pharmaceutical ingredient is 5-aminolevulinic acid hydrochloride (also known as aminolevulinic acid HCl or ALA HCl). Each individual plaster contains 8 mg of 5-aminolevulinic acid, distributed across the 4 cm² adhesive matrix at a concentration of 2 mg/cm². The hydrochloride salt form is used to enhance the chemical stability and skin penetration characteristics of the molecule.

5-Aminolevulinic acid is a naturally occurring amino acid that serves as the first committed precursor in the porphyrin-haem biosynthesis pathway. It is endogenously produced in virtually all nucleated mammalian cells within the mitochondria, catalysed by the enzyme ALA synthase. When exogenous ALA is applied to the skin, it bypasses the normal regulatory feedback mechanisms of haem synthesis, leading to the accumulation of the photosensitising intermediate protoporphyrin IX.

Excipients and Plaster Components

The Alacare plaster is a multi-layered construction consisting of the following components:

• Backing layer: A skin-coloured, occlusive backing foil that prevents the active ingredient from evaporating or being exposed to light during the application period. The backing foil also serves as the outer surface of the plaster and is designed to be inconspicuous on the skin.
• Adhesive matrix: A self-adhesive polymer matrix that contains the 5-aminolevulinic acid hydrochloride dispersed uniformly throughout. The adhesive ensures firm contact between the medicated matrix and the skin surface for the full 4-hour application period. The matrix is designed to provide controlled, consistent release of the active ingredient into the skin.
• Release liner: A protective peel-off liner that covers the adhesive surface before use. This is removed immediately before application to expose the medicated adhesive matrix.

The excipients in the adhesive matrix include acrylic adhesive polymers and other standard pharmaceutical plaster components. Patients with known sensitivities to acrylic adhesives or medical tapes should inform their dermatologist before treatment, as these individuals may be at increased risk of contact dermatitis or allergic reactions at the application site, independent of the PDT reaction itself.

The plaster is square-shaped with rounded corners, measuring approximately 2 cm × 2 cm (4 cm² total surface area). This size is designed to be large enough to cover individual actinic keratosis lesions up to the maximum indicated diameter of 1.8 cm while minimising exposure of surrounding healthy skin to the photosensitiser.