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NCT04877756 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Efficacy of OLX10010 in Reducing Recurrence of Hypertrophic Scarring After Scar Revision Surgery
A Phase 2 study, sponsored by Olix Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT04877756 is a Phase 2 study that has completed, run by Olix Pharmaceuticals. The registered enrollment target is 22 participants.
The verdict
NCT04877756, a Phase 2 study, has completed, sponsored by Olix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
Phase 2a, prospective, randomized, double-blind, intra-subject, placebo-controlled, proof of concept study. Approximately twenty subjects will be randomized 1:1 to one of two treatment arms: Arm A: 2.0 mg/cm OLX10010 biweekly (every two weeks) Arm B: 5.0 mg/cm OLX10010 biweekly (every two weeks) Each treatment arm will have approximately 10 subjects. Each subject will receive both active (OLX10010) and control (placebo) treatment post-hypertrophic scar surgery biweekly (every two weeks) for a total of six doses. Dosing will occur post-surgery on Weeks 2, 4, 6, 8, 10, and 12. Post-treatment follow-up visits will occur at Weeks 18 and 24, and a long-term follow-up visit will occur at Month 12. The Patient and Observer Scar Assessment Scale (both physician and patient scales), Stony Brook Scar Evaluation Scale, Vancouver Scar Scale, and a photograph-based visual analog scale by blinded experts will be completed prior to scar revision surgery, at Weeks 2, 8, 12, 18, and 24, and at Month 12. The overall opinion responses on the physician scales of the POSAS at Week 24 will be used for primary endpoint analysis. The total length of the linear hypertrophic scar line will be divided equally for treatment with OLX10010 and placebo, injected intradermally per centimeter (cm). The OLX10010 end and placebo end of the scar line will be separated by a 2 cm or greater distance depending on the scar length. After the Week 24 visit, all data collected will be cleaned and all data management activities will be completed. After the database is frozen/locked, the primary endpoint efficacy analysis will be completed. If at least one of the treatment arms are shown to be appropriate to reduce recurrence of hypertrophic scars, all analyses will be performed. If the efficacy analysis of Arms A and B indicate the study doses are not as effective as expected, the sponsor may decide to add a third arm (Arm C) to explore the weekly dosing regimen. See detailed summary. Subjects in all stud
Interventions
- DRUG OLX10010
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-08-19 |
| Est. Completion | 2023-07-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04877756
The ClinicalTrials.gov registry entry for NCT04877756 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Olix Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which OLX10010 is the first listed.
NCT04877756 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04877756 about?
NCT04877756 is a clinical study titled "Study to Evaluate Efficacy of OLX10010 in Reducing Recurrence of Hypertrophic Scarring After Scar Revision Surgery". Phase 2a, prospective, randomized, double-blind, intra-subject, placebo-controlled, proof of concept study. Approximately twenty subjects will be randomized 1:1 to one of two treatment arms: Arm A: 2.0 mg/cm OLX10010 biweekly (every two weeks) Arm B: 5.0 mg/cm OLX10010 biweekly (every two weeks) Ea...
What is the current status of trial NCT04877756?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2021-08-19. Estimated completion is 2023-07-12.
What interventions are being tested in trial NCT04877756?
The interventions under investigation include: OLX10010 (DRUG).
Who is sponsoring clinical trial NCT04877756?
This trial is sponsored by Olix Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
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