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NCT05593445 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus
A Phase 2 study, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
NCT05593445: Completed Phase 2 study, sponsored by Incyte Corporation.
NCT05593445 is a Phase 2 study that has completed, run by Incyte Corporation. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05593445, a Phase 2 study, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants With Lichen Sclerosus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 12 weeks followed by an open label period (OLE) period of 12 weeks.
Primary Outcome
ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
Interventions
- DRUG Vehicle cream
- DRUG Ruxolitinib cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2022-11-18 |
| Est. Completion | 2023-12-21 |
| Phase | Phase 2 |
What the finished NCT05593445 record still lists
NCT05593445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle cream is the first listed.
NCT05593445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05593445 about?
NCT05593445 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus". The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants With Lichen Sclerosus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 12 weeks followed by an open label period (OLE) period of 12 weeks.
What is the current status of trial NCT05593445?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2022-11-18. Estimated completion is 2023-12-21.
What interventions are being tested in trial NCT05593445?
The interventions under investigation include: Vehicle cream (DRUG), Ruxolitinib cream (DRUG).
Who is sponsoring clinical trial NCT05593445?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05593445's enrollment target sits among peer trials
61 1026th of 2000 higher than 974 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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