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NCT05048238 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus
A Phase 1 study of Cutaneous Lupus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
- 2
- Study locations
NCT05048238: Completed Phase 1 study of Cutaneous Lupus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05048238 is a Phase 1 study of Cutaneous Lupus that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 7 participants, below the 671-participant average among 3 other Cutaneous Lupus trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05048238, a Phase 1 study of Cutaneous Lupus, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a single-arm, multi-site, proof-of-concept study that will evaluate the treatment of 10 participants with cutaneous lupus erythematosus (CLE) with Tofacitinib.
Primary Outcome
At Day 0 and Day 25, skin was exposed to 10-80 mJ/cm2 UVB irradiation. At Day 1 and Day 26, erythema levels were measured with a Chroma Meter at each dose site and in an unexposed section. Skin biopsies at Day 1 and Day 26 were taken at the unexposed site and at the minimal erythema dose (MED) at Day 1. The percentage of apoptotic epidermal cells were determined in each skin biopsy sample by TUNEL staining. The percentage of UVB-induced apoptotic cells is defined as the difference between the pe
Conditions Studied
Interventions
- DRUG Tofacitinib
Study Locations (2)
Massachusetts
- University of Massachusetts Medical School - Worcester
Michigan
- University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2022-09-30 |
| Est. Completion | 2024-02-29 |
| Phase | Phase 1 |
What the finished NCT05048238 record still lists
NCT05048238 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 671-participant average among 3 other Cutaneous Lupus trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Cutaneous Lupus appearing as the primary indexed condition, and to 1 intervention - of which Tofacitinib is the first listed.
NCT05048238 reports a single indexed study location in Massachusetts, Michigan.
Frequently Asked Questions
What is clinical trial NCT05048238 about?
NCT05048238 is a clinical study titled "Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus". This is a single-arm, multi-site, proof-of-concept study that will evaluate the treatment of 10 participants with cutaneous lupus erythematosus (CLE) with Tofacitinib.
What is the current status of trial NCT05048238?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2022-09-30. Estimated completion is 2024-02-29.
What conditions does trial NCT05048238 study?
This clinical trial studies the following conditions: Cutaneous Lupus.
What interventions are being tested in trial NCT05048238?
The interventions under investigation include: Tofacitinib (DRUG).
Who is sponsoring clinical trial NCT05048238?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05048238 being conducted?
This trial has 2 study locations across Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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