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OLX10010 for Hypertrophic Scar

Phase 2

Waitlist Available

Research Sponsored by Olix Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24 and month 12

Awards & highlights

Study Summary

This trial is a prospective, randomized, double-blind, intra-subject, placebo-controlled, proof of concept study to test the efficacy of two doses of a new treatment for hypertrophic scars. The study will involve approximately 20 subjects who will be randomized 1:1 to one of two treatment arms. Each subject will receive both active treatment and control (placebo) treatment post-hypertrophic scar surgery for a total of six doses. Dosing will occur every two weeks for a total of 12 weeks. Post-treatment follow-up visits will occur at Weeks 18 and 24, and a long-term follow-up visit will occur at

Eligible Conditions

Hypertrophic Scars

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24 and month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24 and month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 and month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

• Change in recurrence of hypertrophic scar after scar revision surgery measured by physician scar assessment using the overall opinion score on the Observer Scar Assessment Scale at Week 24

Secondary outcome measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Severity of Treatment-Emergent Adverse Events [Safety and Tolerability]

• Assessment of Blinded Photographs by Two Independent Assessors

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C 2.0 mg/cm OLX10010 weeklyExperimental Treatment1 Intervention

Arm C- half the scar treated with 2.0 mg/cm of OLX10010 weekly, other half treated with OLX Placebo

Group II: Arm B 5.0 mg/cm OLX10010 biweeklyExperimental Treatment1 Intervention

Arm B- half the scar treated with 5.0 mg/cm of OLX10010 biweekly, other half treated with OLX Placebo

Group III: Arm A 2.0 mg/cm OLX10010 biweeklyExperimental Treatment1 Intervention

Arm A- half the scar treated with 2.0 mg/cm of OLX10010 biweekly, other half treated with OLX Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

OLX10010

2018

Completed Phase 2

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Olix Pharmaceuticals, Inc.Lead Sponsor

3 Previous Clinical Trials

110 Total Patients Enrolled

Alira HealthUNKNOWN

3 Previous Clinical Trials

388 Total Patients Enrolled

Alexander Neumeister, MDStudy DirectorOliX Pharmaceuticals

3 Previous Clinical Trials

68 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical research currently seeking participants?

"The information available from clinicaltrials.gov shows that patient recruitment for this research is ongoing, with the study first posted on July 21st 2021 and last revised on March 10th 2022."

Answered by AI

To what end is this research endeavor striving?

"The primary efficacy measure of this trial, to be assessed at Week 24, is the reduction in recurrence of hypertrophic scar after scar revision surgery. This will be evaluated by patient self-assessment using the Overall Opinion Score on the Patient Scar Assessment Scale. Secondary outcomes include a reoccurence assessment based on Total Patient Scores from PSSS ranging between 6 (normal) and 60 (worst), as well as scar variations evaluated through SBSES with 0 being worst and 5 best score, followed by VSS's severity evaluation scored between 0 for normal skin and 13 for worst possible outcome."

Answered by AI

How can I apply to partake in this clinical study?

"This medical experiment is looking to enrol 30 individuals with hypertrophic scarring, ranging in age from 18 years old up to 65. These participants must have a linear hypertrophic scar that measures 8 cm or more and should not be post-menopausal nor surgically sterile (if they are of child bearing potential). Additionally, the patient's serum pregnancy test needs to come back negative for females who could potentially bear children and informed consent must be properly obtained."

Answered by AI

Could individuals aged 40 or above partake in this experiment?

"According to the requirements, only individuals aged 18-65 can take part in this study. Conversely, there are 175 trials for minors and 981 trials available for seniors."

Answered by AI

Has OLX10010 passed governmental certification to be used therapeutically?

"The safety of OLX10010 was appraised as a 2 since this is an experimental Phase 2 trial with some evidence supporting its security, but no data confirming that it's efficacious."

Answered by AI

In how many locales has this trial been initiated?

"At this time, the trial is running from 6 distinct clinical sites. These are located in Cleveland, Miami and Washington DC as well as 3 other cities. To reduce any travel hassles associated with enrolling it is recommended that patients select a centre close to them."

Answered by AI

How many participants has the clinical trial enrolled thus far?

"To begin the experiment, a minimum of 30 individuals must meet certain eligibility requirements and enroll. Those looking to take part in this research may do so by visiting University Hospitals Cleveland Medical Center or Miami Dermatology & Laser Research, LLC."

Answered by AI