This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

5-aminolevulinic acid hydrochloride topical

Updated 2 Feb 2023 | Photodamaged skin treatments


Gel containing 5-aminolevulinic acid (as hydrochloride).

Drugs List

  • 5-aminolevulinic acid hydrochloride 78mg/g gel
  • AMELUZ 78mg/g gel
  • Therapeutic Indications


    Treatment of actinic keratoses in combination with photodynamic therapy
    Treatment of nodular basal cell carcinoma (other treatment unsuitable)
    Treatment of superficial basal cell carcinoma (other treatment unsuitable)

    Treatment of mild to moderate actinic keratoses and of field cancerization.

    Treatment of basal cell carcinoma (BCC), superficial and/or nodular, when surgical treatment is unsuitable.


    To be applied before photodynamic therapy.

    Before applying, remove scales and crusts. If an epidermal keratin layer is covering nodular basal cell carcinoma lesions it should also be removed as well as any tumour material exposed. Lesion surfaces should be roughened gently. Care should be taken to avoid bleeding. Carefully wipe off lesions with an ethanol or isopropanol soaked cotton pad to degrease the skin.

    Application of an occlusive dressing and incubation are required before red-light photodynamic therapy. No dressing is required before daylight photodynamic therapy.

    Photodynamic therapy should be employed in accordance with manufacturer's information and local protocol.


    Apply gel to cover the lesions or entire fields with cancerization of about 20cm squared and approximately 5mm of the surrounding area with a film of about 1mm thickness.

    Actinic keratoses (AK) of the face or scalp: One session of photodynamic therapy (with daylight or red-light lamp).
    Actinic keratoses (AK) in the body region trunk, neck or extremities: One session of narrow spectrum red-light photodynamic therapy.
    Basal cell carcinoma (BCC): Two sessions of photodynamic therapy (with red-light lamp) one week apart.


    Children under 18 years
    Hypersensitivity to soya or soya derivative
    Photoactive disorder

    Precautions and Warnings


    Avoid concurrent use of immunosuppressants
    Discontinue UV therapy before starting treatment
    No experience if area to be treated affected by skin disease or tattoos
    Treatment to be initiated and supervised by a specialist
    Contains propylene glycol: may cause irritation
    Contains sodium benzoate - mildly irritant to eyes, skin & mucous membranes
    Contains soya or soya derivative
    Avoid concurrent use of photosensitising agents
    Avoid contact with ears
    Avoid contact with mucous membranes
    Avoid contact with nostrils or mouth
    Avoid use in or near eyes
    Avoid use on bleeding lesions
    If accidental contact with eyes or mucous membranes - rinse with cool water
    Staff & patients: Protective goggles for the lamp spectrum used to be worn
    Discontinue immediately if amnesia occurs
    Evaluate the patient 3 months after treatment
    Monitor basal cell carcinoma closely long term
    Amnesia may occur
    Hypersensitivity may occur before or after illumination
    Advise patient not to take St John's wort concurrently
    Breastfeeding: Do not breastfeed & discard milk for 12 hours after therapy
    Advise patient on appropriate sun protection methods
    Avoid sun exposure for 48 hours after treatment

    Pregnancy and Lactation


    Use 5-aminolevulinic with caution during pregnancy.

    The manufacturer recommends 5-aminolevulinic acid is not used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. Animal studies do not indicate direct/indirect harmful effects regarding reproductive toxicity. At the time of writing there is limited human data available. Risks are unknown.


    Use 5-aminolevulinic with caution during breastfeeding.

    The manufacturer notes that it is unknown whether 5-aminolevulinic acid/metabolites are excreted in human milk. A risk to the breast-fed infant cannot be excluded and breast-feeding should be discontinued for 12 hours after treatment with 5-aminolevulinic acid.

    Side Effects

    Amnesia (transient)
    Back pain
    Blurred vision
    Crusting of skin
    Discharge (application site)
    Dry skin
    Erythema at application site
    Eyelid oedema
    Feeling hot
    Hot flushes
    Hypersensitivity reactions
    Impaired vision
    Inflammation (application site)
    Irritation (localised)
    Local swelling
    Localised exfoliation
    Oedema at application site
    Pain at application site
    Pustular rash
    Sensation of warmth
    Skin discolouration
    Skin discomfort
    Skin reactions
    Skin tightness
    Skin ulcer
    Wound secretion


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: August 2019

    Reference Sources

    Summary of Product Characteristics: Ameluz 78mg/g gel. Biofrontera Pharma GmbH. Revised March 2020.

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.