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Open-label, prospective study evaluating the efficacy and safety of Tirbanibulin 1% (Klisyri®) in the treatment of superficial basal cell carcinoma

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505971-66-00
Acronym
23-PP-04
Enrollment
55
Registered
2023-10-05
Start date
2023-11-17
Completion date
Unknown
Last updated
2025-07-17

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

Conditions

Superficial Basal cell carcinoma

Brief summary

Complete remission (CR) of BCC at the end of treatment. CR is defined as the absence of evidence of BCC clinically and on LC-OCT.

Detailed description

Type, frequency, severity and time of onset of side effects. Side effects will be classified into grades based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) scale. The intensity of short-term local side effects will be assessed using the LSR score., Complete remission of BCCs after 1, 2, 3, or 4 cycles of treatment., LC-OCT measurement of BCC thickness., TSQM9 score.

Interventions

Sponsors

Centre Hospitalier Universitaire De Nice
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Complete remission (CR) of BCC at the end of treatment. CR is defined as the absence of evidence of BCC clinically and on LC-OCT.

Secondary

MeasureTime frame
Type, frequency, severity and time of onset of side effects. Side effects will be classified into grades based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) scale. The intensity of short-term local side effects will be assessed using the LSR score., Complete remission of BCCs after 1, 2, 3, or 4 cycles of treatment., LC-OCT measurement of BCC thickness., TSQM9 score.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026