Exploratory pilot study to determine the tolerability and effectiveness of Tirbanibulin in the treatment of Actinic Cheilitis

Conditions

Actinic Cheilitis

Brief summary

Complete recovery rate (healing) of Actinic Cheilitis, 8 weeks after the application of Tirbanibulin for 5 days (visit 4, day 56). Complete recovery is defined as an affected area of 0 cm.

Detailed description

Reduction of the affected area by means of the size of the affected lip area in cm² and the reduction of the affected area in % at day 56 compared to baseline (area in cm² at baseline, area in cm² at day 56, reduction of the area in %), Study subject self-assessment (individual and total scores according to the visit schedule as well as the difference of the scores compared to baseline), Local skin reaction score (individual and total scores as per visit schedule as well as the difference of the scores compared to baseline, Oral Health DLQI-Score (individual and total scores as per visit as well as the difference of the scores compared to baseline), Frequency of AEs and SAEs during the duration of the trial (visit 4), Discrepancies in diagnosing Actinic Cheilitis by means of optical coherence tomography, confocal laser scanning microscopy, line-field confocal optical coherence tomography, diagnostic confidence, imaging quality at baseline compared to the final visit.

Related papers

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Interventions

DRUGKlisyri 10 mg/g ointment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Complete recovery rate (healing) of Actinic Cheilitis, 8 weeks after the application of Tirbanibulin for 5 days (visit 4, day 56). Complete recovery is defined as an affected area of 0 cm.	—

Secondary

Measure	Time frame
Reduction of the affected area by means of the size of the affected lip area in cm² and the reduction of the affected area in % at day 56 compared to baseline (area in cm² at baseline, area in cm² at day 56, reduction of the area in %), Study subject self-assessment (individual and total scores according to the visit schedule as well as the difference of the scores compared to baseline), Local skin reaction score (individual and total scores as per visit schedule as well as the difference of the scores compared to baseline, Oral Health DLQI-Score (individual and total scores as per visit as well as the difference of the scores compared to baseline), Frequency of AEs and SAEs during the duration of the trial (visit 4), Discrepancies in diagnosing Actinic Cheilitis by means of optical coherence tomography, confocal laser scanning microscopy, line-field confocal optical coherence tomography, diagnostic confidence, imaging quality at baseline compared to the final visit.	—

Measure

Time frame

Reduction of the affected area by means of the size of the affected lip area in cm² and the reduction of the affected area in % at day 56 compared to baseline (area in cm² at baseline, area in cm² at day 56, reduction of the area in %), Study subject self-assessment (individual and total scores according to the visit schedule as well as the difference of the scores compared to baseline), Local skin reaction score (individual and total scores as per visit schedule as well as the difference of the scores compared to baseline, Oral Health DLQI-Score (individual and total scores as per visit as well as the difference of the scores compared to baseline), Frequency of AEs and SAEs during the duration of the trial (visit 4), Discrepancies in diagnosing Actinic Cheilitis by means of optical coherence tomography, confocal laser scanning microscopy, line-field confocal optical coherence tomography, diagnostic confidence, imaging quality at baseline compared to the final visit.

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Countries

Germany

Outcome results

None listed