Study to Evaluate Efficacy of OLX10010 in Reducing Recurrence of Hypertrophic Scarring After Scar Revision Surgery
Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
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 and patient scales of the POSAS at Week 24 will be used for
coprimary 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 coprimary 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 study arms will continue in the study until their Month 12 visit. After all
subjects complete that visit, data are collected, and data management activities are
completed, Month 12 data will be analyzed.