Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648447
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses with Downward-directed Proliferation Patterns
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses with Downward-directed Proliferation Patterns
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Tir2401
Brief Summary:
The aim of this study is to observe the influence of tirbanibulin on proliferation patterns of actinic keratoses efficacy on proliferation score according to Schmitz et al For this purpose tirbanibulin is applied in-label proliferation is measured by LC-OCT at different time points and dermatohistopathology is performed optionally at the end Local skin reactions to the product will also be recorded tolerability
Detailed Description:
Actinic keratoses AK are premalignant skin changes of a cutaneous squamous cell carcinoma SCC which are often triggered by UV exposure Clinically they appear as small rough reddish sandpaper-like patches occasionally also as hyperkeratotic lesions They are one of the most common reasons for dermatological consultations and their incidence has been steadily increasing in recent years due to changes in leisure habits with increased UV exposure and demographic changes in the population such as those observed in Germany
While the mortality rate of squamous cell carcinoma of the skin is low the persistence and recurrence of AK which requires frequent treatment is a challenge for both patients and healthcare systems
There are numerous treatment options for AK ranging from surgical and cryosurgical interventions to ablative laser treatments topical and photodynamic therapies These treatments can generally be categorized as lesion- or field-oriented
Some AK show resistance to conventional therapies This could possibly be due to different proliferation patterns of AK Schmitz et al established the PRO score an instrument that describes the proliferation behavior of AK in a three-stage scale This histological score is well validated and is increasingly used in histological diagnostics New imaging techniques such as confocal line-field optical coherence tomography LC-OCT enable real-time assessment of histological parameters without the need for biopsies In LC-OCT it is possible to detect the PRO Score of an AK in a few seconds
Clinical parameters such as the Olsen grade on the other hand record the visible or palpable hyperkeratosis of an AK However the significance of hyperkeratosis for the risk of progression of AK to SCC is only of minor importance Histological diagnostics and LC-OCT therefore make it possible to determine this risk more precisely
Similarly clinical scores such as the Olsen garde do not indicate which AKs are refractory to therapy and which respond to therapy One reason for this could be the proliferation behavior of the individual AK Tirbanibulin which primarily targets this cell proliferation is a promising agent for the treatment of highly proliferative AK PRO II and III One aim is to observe its effects on basal proliferation after treatment which can be assessed in real time using LC-OCT This non-invasive method provides rapid evaluations within minutes In addition to efficacy in proliferative AK evaluation of the tolerability of tirbanibulin is crucial to contextualize its role in therapy It is therefore of interest to determine whether increased skin reactions in proliferative AK correlate with improved clearance rates
Tirbanibulin is a method frequently used in practice for the treatment of actinic keratoses The application is quick with only 5 consecutive applications results in only a minor local reaction and is nevertheless effective In this study various parameters such as local tolerance the Olsen grade and the PRO score will be monitored using LC-OCT Patients with clinically confirmed AK for whom in-label therapy with tirbanibulin is planned anyway will be included
While the mortality rate of squamous cell carcinoma of the skin is low the persistence and recurrence of AK which requires frequent treatment is a challenge for both patients and healthcare systems
There are numerous treatment options for AK ranging from surgical and cryosurgical interventions to ablative laser treatments topical and photodynamic therapies These treatments can generally be categorized as lesion- or field-oriented
Some AK show resistance to conventional therapies This could possibly be due to different proliferation patterns of AK Schmitz et al established the PRO score an instrument that describes the proliferation behavior of AK in a three-stage scale This histological score is well validated and is increasingly used in histological diagnostics New imaging techniques such as confocal line-field optical coherence tomography LC-OCT enable real-time assessment of histological parameters without the need for biopsies In LC-OCT it is possible to detect the PRO Score of an AK in a few seconds
Clinical parameters such as the Olsen grade on the other hand record the visible or palpable hyperkeratosis of an AK However the significance of hyperkeratosis for the risk of progression of AK to SCC is only of minor importance Histological diagnostics and LC-OCT therefore make it possible to determine this risk more precisely
Similarly clinical scores such as the Olsen garde do not indicate which AKs are refractory to therapy and which respond to therapy One reason for this could be the proliferation behavior of the individual AK Tirbanibulin which primarily targets this cell proliferation is a promising agent for the treatment of highly proliferative AK PRO II and III One aim is to observe its effects on basal proliferation after treatment which can be assessed in real time using LC-OCT This non-invasive method provides rapid evaluations within minutes In addition to efficacy in proliferative AK evaluation of the tolerability of tirbanibulin is crucial to contextualize its role in therapy It is therefore of interest to determine whether increased skin reactions in proliferative AK correlate with improved clearance rates
Tirbanibulin is a method frequently used in practice for the treatment of actinic keratoses The application is quick with only 5 consecutive applications results in only a minor local reaction and is nevertheless effective In this study various parameters such as local tolerance the Olsen grade and the PRO score will be monitored using LC-OCT Patients with clinically confirmed AK for whom in-label therapy with tirbanibulin is planned anyway will be included
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None