Hypertrophic ScarPhase 2NCT04877756
Study to Evaluate Efficacy of OLX10010 in Reducing Recurrence of Hypertrophic Scarring After Scar Revision Surgery
A Phase 2 study testing OLX10010 in people with Hypertrophic Scar, run by Olix Pharmaceuticals, Inc. at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertrophic Scar
- What is being tested?
- OLX10010
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 6 sitesUnited States
- Study dates
- 19 Aug 2021to 12 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Henry Ford Health System
Detroit, Michigan, 48202
Miami Dermatology & Laser Research, LLC
Miami, Florida, 33173
Miami Plastic Surgery
Miami, Florida, 33176
Paddington Testing Co, Inc.
Philadelphia, Pennsylvania, 19103
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: Phase 2a Prospective, Randomized, Double-blind, Intra-subject, Placebo-controlled, Proof of Concept Study to Evaluate the Efficacy of OLX10010 as an Adjunct Therapy to Reduce the Recurrence of Hypertrophic Scars 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) 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.
Read more
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 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.
Read the 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:
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 distance of 2 cm or greater 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:
Arm C: 2.0 mg/cm OLX10010 weekly If added, Arm C will enroll 10 subjects. Each subject will receive both active (OLX10010) and control (placebo) treatment post-hypertrophic scar surgery weekly for a total of 11 doses. Dosing will occur post-surgery on Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12. Post-treatment follow-up visits will occur on 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 two blinded independent assessors 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. After all subjects in Arm C complete Week 24, all data are collected, and all data management activities are completed, a new database freeze/lock will be performed. Arm C data will be analyzed.
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.
- Conditions
- Hypertrophic Scar
- Being tested
- OLX10010
- Keywords
- scar revision surgery, OLX10010, siRNA
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLX10010Drug
Also called a cell penetrating asymmetric small interference RNA (cp-asiRNA), targeting a gene involved in formation of fibrosis
Lyophilized cake reconstituted with WFI and injected intradermally
| Study group | Role | What they receive |
|---|---|---|
| Arm A 2.0 mg/cm OLX10010 biweekly | Experimental | Arm A- half the scar treated with 2.0 mg/cm of OLX10010 biweekly, other half treated with OLX Placebo Receives: Drug: OLX10010 |
| Arm B 5.0 mg/cm OLX10010 biweekly | Experimental | Arm B- half the scar treated with 5.0 mg/cm of OLX10010 biweekly, other half treated with OLX Placebo Receives: Drug: OLX10010 |
| Arm C 2.0 mg/cm OLX10010 weekly | Experimental | Arm C- half the scar treated with 2.0 mg/cm of OLX10010 weekly, other half treated with OLX Placebo Receives: Drug: OLX10010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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
- The change of recurrence of hypertrophic scar will be measured by Observer Scar Assessment Scale to rate Vascularity, pigmentation, thickness, relief, pliability, and surface area on a ten point scale with 1 representing normal sensation or skin and 10 indicating the worst imaginable sensation or skin.
Measured: Week 24
Secondary outcomes (8)
• Change in the recurrence of hypertrophic scar after scar revision surgery measured by patient scar assessment using the overall opinion score on the Patient Scar Assessment Scale at Week 24
- The change of recurrence of hypertrophic scar will be measured by Patient Scar Assessment Scale to rate Vascularity, pigmentation, thickness, relief, pliability, and surface area on a ten point scale with 1 representing normal sensation or skin and 10 indicating the worst imaginable sensation or skin.
Measured: Week 24
• Recurrence of hypertrophic scar after scar revision surgery at Weeks 2, 8, 12, 18, and 24 and Month 12 according to Physician
- Physician scar assessment: Using Total Observer Score from Observer Scar Assessment Scale which is generated by adding all values rated on the scale for that timepoint. Possible scores will be 6 (normal) up to 60 (worst possible)
Measured: Week 24 and Month 12
• Recurrence of hypertrophic scar after scar revision surgery at Weeks 2, 8, 12, 18, and 24 and Month 12 according to Patient
- Patient scar self-assessment: Using Total Patient Score from Patient Scar Assessment Scale which is generated by adding all values rated on the scale for that timepoint. Possible scores will be 6 (normal) up to 60 (worst possible)
Measured: Week 24 and Month 12
• Scar severity
- Vancouver Scar Scale (VSS) which consists of four variables: vascularity, height (thickness), pliability, and pigmentation. Each variable has four to six possible scores. A total score ranges from 0 to 13, whereby a score of 0 reflects normal skin.
Measured: Week 24 and Month 12
• Assessment of Blinded Photographs by Two Independent Assessors:
The visual analog scale is a photograph-based scale derived from evaluating standardized digital photographs. Two independent assessors, blinded to study arm and timepoint, assess the overall improvement of scar appearance (from 0 as the worst to 10 as the best) by reviewing blinded photographs. Each independent assessor completes the 10 cm VAS for both ends (OLX10010 and placebo) of the scar. Mean values of VAS scores assessed by two independent assessors will be used for efficacy analysis.
Measured: Week 24 and Month 12
• Scar variations
- Stony Brook Scar Evaluation Scale (SBSES) assesses the individual attributes like width, height, color, suture marks, and overall appearance with a binary response (0 or 1) for each. The total score range is from 0 (worst) to 5 (best) scar.
Measured: Week 24 and Month 12
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- Measured by Adverse Events incidence
Measured: Week 24 and Month 12
Severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
- Measured by Adverse Events severity
Measured: Week 24 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start19 Aug 2021
- Primary completion11 Jan 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 parallel arms and then a 3rd arm will be enrolled if the endpoints for the first 2 arms aren't met.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alira Health
- Responsible party
- Sponsor
- Investigators
- Alexander Neumeister, MD, Study director, OliX Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877756
- Sponsor's protocol ID
- OLX10010-02
- Status last verified
- Feb 2024
- First submitted
- 22 Apr 2021
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hwang J, Chang C, Kim JH, Oh CT, Lee HN, Lee C, Oh D, Lee C, Kim B, Hong SW, Lee DK. Development of Cell-Penetrating Asymmetric Interfering RNA Targeting Connective Tissue Growth Factor. J Invest Dermatol. 2016 Nov;136(11):2305-2313. doi: 10.1016/j.jid.2016.06.626. Epub 2016 Jul 15.
PubMed 27427487
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Prospective, Randomized, Double-blind, Intra-subject, Placebo-controlled, Proof of Concept Study to Evaluate the Efficacy of OLX10010 as an Adjunct Therapy to Reduce the Recurrence of Hypertrophic Scars After Scar Revision Surgery
- ClinicalTrials.gov ID
- NCT04877756
- Acronym / sponsor ID
- OLX10010-02
- Conditions
- Hypertrophic Scar
- Keywords
- scar revision surgery, OLX10010, siRNA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Olix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Alira Health
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
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:
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 distance of 2 cm or greater 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:
Arm C: 2.0 mg/cm OLX10010 weekly If added, Arm C will enroll 10 subjects. Each subject will receive both active (OLX10010) and control (placebo) treatment post-hypertrophic scar surgery weekly for a total of 11 doses. Dosing will occur post-surgery on Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12. Post-treatment follow-up visits will occur on 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 two blinded independent assessors 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. After all subjects in Arm C complete Week 24, all data are collected, and all data management activities are completed, a new database freeze/lock will be performed. Arm C data will be analyzed.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 2 parallel arms and then a 3rd arm will be enrolled if the endpoints for the first 2 arms aren't met.
| Arm | Type | Receives |
|---|---|---|
| Arm A 2.0 mg/cm OLX10010 biweekly | Experimental | Drug: OLX10010Arm A- half the scar treated with 2.0 mg/cm of OLX10010 biweekly, other half treated with OLX Placebo |
| Arm B 5.0 mg/cm OLX10010 biweekly | Experimental | Drug: OLX10010Arm B- half the scar treated with 5.0 mg/cm of OLX10010 biweekly, other half treated with OLX Placebo |
| Arm C 2.0 mg/cm OLX10010 weekly | Experimental | Drug: OLX10010Arm C- half the scar treated with 2.0 mg/cm of OLX10010 weekly, other half treated with OLX Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OLX10010Also: a cell penetrating asymmetric small interference RNA (cp-asiRNA), targeting a gene involved in formation of fibrosisLyophilized cake reconstituted with WFI and injected intradermally | Drug | Arm A 2.0 mg/cm OLX10010 biweekly, Arm B 5.0 mg/cm OLX10010 biweekly, Arm C 2.0 mg/cm OLX10010 weekly |
Primary outcome
• 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
Time frame: Week 24
• The change of recurrence of hypertrophic scar will be measured by Observer Scar Assessment Scale to rate Vascularity, pigmentation, thickness, relief, pliability, and surface area on a ten point scale with 1 representing normal sensation or skin and 10 indicating the worst imaginable sensation or skin.
8 secondary outcomes
• Change in the recurrence of hypertrophic scar after scar revision surgery measured by patient scar assessment using the overall opinion score on the Patient Scar Assessment Scale at Week 24
Time frame: Week 24
• Recurrence of hypertrophic scar after scar revision surgery at Weeks 2, 8, 12, 18, and 24 and Month 12 according to Physician
Time frame: Week 24 and Month 12
• Recurrence of hypertrophic scar after scar revision surgery at Weeks 2, 8, 12, 18, and 24 and Month 12 according to Patient
Time frame: Week 24 and Month 12
• Scar severity
Time frame: Week 24 and Month 12
• Assessment of Blinded Photographs by Two Independent Assessors:
Time frame: Week 24 and Month 12
• Scar variations
Time frame: Week 24 and Month 12
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Week 24 and Month 12
Severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Week 24 and Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Background: PubMed 27427487Hwang J, Chang C, Kim JH, Oh CT, Lee HN, Lee C, Oh D, Lee C, Kim B, Hong SW, Lee DK. Development of Cell-Penetrating Asymmetric Interfering RNA Targeting Connective Tissue Growth Factor. J Invest Dermatol. 2016 Nov;136(11):2305-2313. doi: 10.1016/j.jid.2016.06.626. Epub 2016 Jul 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Neumeister, MD study director
OliX Pharmaceuticals
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OLX10010 in people with Hypertrophic Scar, run by Olix Pharmaceuticals, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• 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 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04877756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.