following a full submission:
5-aminolaevulinic acid (as hydrochloride) (Ameluz®) is accepted for use within NHSScotland.
Indication under review: treatment of actinic keratosis of mild to moderate intensity on the face and scalp (Olsen grade 1 to 2).
In a multi-centre, randomised, observer-blind, controlled phase III study, 5-aminolaevulinic acid gel met pre-specified non-inferiority criteria compared with an alternative topical agent in terms of complete clearance of actinic keratosis lesions, 12 weeks after the last of up to two sessions of photodynamic therapy. The treatment difference was sufficient to demonstrate superiority over the alternative topical agent.
Please see additional notes section below.
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Medicine details
- Medicine name:
- 5-aminolaevulinic acid (Ameluz)
- SMC ID:
- 811/12
- Indication:
For the treatment of actinic keratosis of mild to moderate intensity on the face and scalp.
- Pharmaceutical company
- Biofrontera Bioscience GmbH
- BNF chapter
- Skin
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 10 December 2012
In March 2020 the marketing authorisation for 5-aminolevulinic acid hydrochloride (Ameluz) was extended for the treatment of actinic keratosis of mild to moderate severity and of field cancerization in adults. This change will not be assessed by SMC.