Status:
COMPLETED
Study to Evaluate Efficacy of OLX10010 in Reducing Recurrence of Hypertrophic Scarring After Scar Revision Surgery
Lead Sponsor:
Olix Pharmaceuticals, Inc.
Collaborating Sponsors:
Alira Health
Conditions:
Hypertrophic Scar
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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...
Detailed Description
This is a 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:...
Eligibility Criteria
Inclusion
- Healthy males or females, aged 18 to 65, inclusive
- Hypertrophic scar in the abdominal region, from previous surgery or injury, present for ≥ 12 months
- Linear hypertrophic scar equal to or greater than 8 cm in length
- Undergoing elective hypertrophic scar revision surgery
- Serum pregnancy test negative for females of childbearing potential
- Males and females of child-bearing potential (e.g., not post-menopausal for at least one year or surgically sterile) must agree to use effective contraception starting at the Screening Visit and continuing until 14 days after the last dose of OLX10010.
- Properly obtained written informed consent
Exclusion
- BMI greater than 32 kg/m2. Exceptions to this criteria can be granted for patients just over this value per PI's discretion
- Hypertrophic scars outside the abdominal area, including face, neck, back, limbs, and the thoracic region
- Hypertrophic scar secondary to burns
- Active infection near the scar revision surgery
- Clinically significant wound near the scar revision surgery
- Additional scar(s) within 2 cm of the scar revision surgery
- End-stage renal disease or severe renal impairment as indicated by serum creatinine \> 2.5 mg/dL
- Tanning (natural or artificial) within 14 days prior to the screening visit or unwilling to abstain from natural or artificial tanning for four weeks after surgery. Tanning is not recommended for the remainder of the study but will not be an exclusion criteria or reason for early termination.
- Hypertrophic scar treatment within 12 weeks prior to the screening visit, excluding scar revision surgery
- Radiation or chemotherapy within 12 weeks prior to the screening visit
- Treatment with anti-psychotic, anti-cancer, immunosuppressant, or corticosteroids within 12 weeks prior to the screening visit
- Atopic dermatitis, keloid scar, or skin hypersensitivity
- Received elective body sculpting procedures (e.g., CoolSculpting®) for the abdomen within the past 6 months
- Use of tobacco or nicotine-containing products during study participation (Screening Visit through last follow-up visit)
- Female patients who are pregnant or breastfeeding
- Participation in any experimental drug or device study within 30 days prior to the screening visit
- Any clinically significant finding, in the judgement of the treating investigator, that would place the subject at health risk, impact the study, or affect the completion of the study.
Key Trial Info
Start Date :
August 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04877756
Start Date
August 19 2021
End Date
July 12 2023
Last Update
February 21 2024
Active Locations (6)
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1
MedStar Health Research Institute
Washington D.C., District of Columbia, United States, 20010
2
Miami Dermatology & Laser Research, LLC
Miami, Florida, United States, 33173
3
Miami Plastic Surgery
Miami, Florida, United States, 33176
4
Henry Ford Health System
Detroit, Michigan, United States, 48202