Skip to content

Evaluation of the efficacy and safety of photodynamic therapy with BF-200 ALA (Ameluz®) in immunosuppressed patients with actinic keratoses and superficial basal cell carcinoma at any location.

Status
Not yet recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526649-85-00
Enrollment
120
Registered
2026-08-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

and basal cell carcinoma (BCC), cutaneous squamous cell carcinoma (cSCC), due to chronic immunosuppression., Immunosuppressed patients with premalignant and malignant skin lesions, such as actinic keratosis (AK)

Brief summary

The complete clearance rate of lesions at 3 months, defined as the complete clinical disappearance of the treated lesion.

Detailed description

Reduction in the AKASI index: analyzed using an independent samples Student’s t-test or the Mann–Whitney U test depending on distribution., Recurrence or persistence at 6–12 months: analyzed using χ²/Fisher’s exact test., ncidence of new actinic keratoses (AK) or non-melanoma skin cancer (NMSC): comparison of proportions between groups.

Interventions

DRUGAmeluz 78 mg/g gel

Sponsors

Dra. Elena González Guerra
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The complete clearance rate of lesions at 3 months, defined as the complete clinical disappearance of the treated lesion.

Secondary

MeasureTime frame
Reduction in the AKASI index: analyzed using an independent samples Student’s t-test or the Mann–Whitney U test depending on distribution., Recurrence or persistence at 6–12 months: analyzed using χ²/Fisher’s exact test., ncidence of new actinic keratoses (AK) or non-melanoma skin cancer (NMSC): comparison of proportions between groups.

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 25, 2026