medcelerator · clinician one-pager
Ameluz Red-Light PDT Now FDA-Approved for Superficial Basal Cell Skin Cancer
Ameluz (aminolevulinic acid HCl 10% gel) — red-light PDT for superficial basal cell carcinoma
FDA Approved · United States · September 22, 2026
Condition: Superficial Basal Cell Carcinoma
Who this is for
This is for adults with superficial basal cell carcinoma — and the caregivers helping them — who may be candidates for labelled US Ameluz red-light PDT with a BF-RhodoLED or RhodoLED XL clinic lamp. It explains the 9 Sep 2026 sBCC expansion, Trial 4 clearance numbers, the two-session clinic regimen, photosensitivity and application-site pain honesty, how to ask a dermatologist for a PDT clinic that stocks the lamp, and why authorised is not funded — without treating Ameluz as home DIY gel, confusing this with the older AK-only story as the main door, or importing US tubes. Authorized is not funded.
Next clinical step
This is FDA authorised, not Health Canada authorised. Ask the clinician about US care, a trial, or a Special Access Programme path in United States.
Access doors
ClinicalTrials.gov
US National Library of Medicine registry of clinical studies. Search by condition, drug, NCT number, and location. A listing is not enrolment, eligibility, or funding. Talk with the trial contact and a clinician before assuming a slot exists.
https://clinicaltrials.gov/
FDA Expanded Access (Patient Affairs)
US Food and Drug Administration path for a licensed clinician to request an investigational medical product for a patient with a serious or immediately life-threatening condition when no comparable approved therapy is available. This is a request path, not a labelled indication. Authorized is not funded.
https://www.fda.gov/news-events/public-health-focus/expanded-access
Not medical advice. Authorized is not funded. Full piece: https://medcelerator.com/articles/ameluz-aminolevulinic-acid-sbcc