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| Name | Class |
|---|---|
| Alira Health | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OLX10010 | Drug | Lyophilized cake reconstituted with WFI and injected intradermally |
|
| Measure | Description | Time Frame |
|---|---|---|
| • 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. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| • 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Neumeister, MD | OliX Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Health Research Institute | Washington D.C. | District of Columbia | 20010 | United States | ||
| Miami Dermatology & Laser Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27427487 | Background | 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. |
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2 parallel arms and then a 3rd arm will be enrolled if the endpoints for the first 2 arms aren't met.
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|
| 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) | 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) | 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. | 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. | 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. | Week 24 and Month 12 |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | • Measured by Adverse Events incidence | Week 24 and Month 12 |
| Severity of Treatment-Emergent Adverse Events [Safety and Tolerability] | • Measured by Adverse Events severity | Week 24 and Month 12 |
| Miami |
| Florida |
| 33173 |
| United States |
| Miami Plastic Surgery | Miami | Florida | 33176 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Paddington Testing Co, Inc. | Philadelphia | Pennsylvania | 19103 | United States |
| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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