Back to resultsA Randomized Study to Evaluate the Safety and Efficacy of Various Doses of STP705 in Subjects With Hypertrophic Scar
Primary Purpose
Hypertrophic Scar
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
STP705
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertrophic Scar
Eligibility Criteria
Inclusion Criteria:
- Subject is able to understand and willing to conform to the study procedures and has signed the informed consent form (ICF).
- Subject is male or female, between the ages of 18 and 60 years, inclusive.
Subject with a hypertrophic scar that meet all of the following criteria:
- linear scar, ≥5 to ≤40 cm in length (Cohort A), ≥5 to ≤50 cm in length (Cohort B), ≥5 to ≤60 cm in length (Cohort C)
- present for minimum 6 months and no greater than 24 months
- located anywhere in the body except on the face or front of neck
- resulting from surgical or traumatic injury
- Subject is judged, by the Investigator, to be healthy as evidenced by lack of clinically significant abnormal findings on medical history, physical examination, electrocardiogram, vital signs, and clinical laboratory tests.
- Subject is willing and able to complete the entire course of the trial and to comply with the trial instructions.
- Subject, if female of child-bearing potential, has a negative serum pregnancy test at screening and a negative urine pregnancy test at prior to treatment and willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) throughout the study.
Exclusion Criteria:
- Subjects identified as having keloid or burn scars
- Subjects who are positive for hepatitis B surface antigen (HbsAg), hepatitis C antibody and HIV.
- Concurrent use of corticosteroids (including inhaled steroids) and COX-2 inhibitors
- Are immuno-compromised (HIV infected, cancer and other disease affecting the basal immune response)
- Clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the Investigator, not stabilized or may otherwise impact the results of the study.
- Known allergy or hypersensitivity to the study drug(s) or one of the ingredients of the formulation.
- Any infection or wound in the area to treat.
- Female subjects who are pregnant or breast-feeding.
- Participation in a clinical study involving administration of an investigational compound within the past 30 days.
- Existence of any surgical, medical or laboratory condition that, in the judgment of the clinical investigator, might interfere with the safety, distribution, metabolism or excretion of the drug.
Sites / Locations
- WCCT Global
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
STP705
Placebo
Arm Description
Each subject will receive both active (STP705) and control (Placebo) intradermal injection twice a week for a total of 4 weeks at 20 μg/cm2/day (in Cohort A), 30 μg/cm2/day (in Cohort B) and 40 μg/cm2/day (in cohort C). The total length of linear hypertrophic scar will be divided equally for treatment with STP705 and placebo. STP705 and Placebo will be injected intradermal every 1 cm length on the hypertrophic scar.
Each subject will receive both active (STP705) and control (Placebo) intradermal injection twice a week for a total of 4 weeks at 20 μg/cm2/day (in Cohort A), 30 μg/cm2/day (in Cohort B) and 40 μg/cm2/day (in cohort C). The total length of linear hypertrophic scar will be divided equally for treatment with STP705 and placebo. STP705 and Placebo will be injected intradermal every 1 cm length on the hypertrophic scar
Outcomes
Primary Outcome Measures
Differences among the 3 dosage Groups in 24 Patients' appearance of the scar from baseline evaluated by Patient and Observer Scar Assessment Scale (POSAS)
Secondary Outcome Measures
Change in appearance of the scar from baseline evaluated by Physician Global Assessment using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS) at T4, T8, FU1, FU2 and FU3 visits.
Physician global assessment will be performed using the overall opinion question of the POSAS scale. Physicians will be asked to rate the severity of the participant's scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within participant treatment difference from baseline will be assessed separately for Site A and Site B.
Change in appearance of the scar from baseline evaluated by Physician Scar Assessment using Complete Patient and Observer Scar Assessment Scale (POSAS) at T4, T8, FU1, FU2 and FU3 visits.
Within participant treatment difference from baseline will be assessed separately for Site A and Site B.
Change in appearance of the scar from baseline evaluated by Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at T4, T8, FU1, FU2 and FU3 visits
Patient global assessment was performed using the overall opinion question of the POSAS scale.
Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin). Within participant treatment difference from baseline will be assessed separately for Site A and Site B.
Change in volume/size of the scar from baseline evaluated by volumetric measurement using 3D camera at T4, T8, FU1, FU2 and FU3 visits
Within participant treatment difference from baseline will be assessed separately for Site A and Site B.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02956317
Brief Title
A Randomized Study to Evaluate the Safety and Efficacy of Various Doses of STP705 in Subjects With Hypertrophic Scar
Official Title
A Randomized, Double-Blind, Within-Subject Placebo Controlled Study to Evaluate the Safety and Efficacy of Various Doses of STP705 Administered as Intradermal Injection in Subjects With Hypertrophic Scar.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sirnaomics
4. Oversight
5. Study Description
Brief Summary
This is a randomized, double-blind, within-subject placebo controlled study to evaluate the safety and efficacy of various doses of STP705 administered as intradermal Injection in subjects with hypertrophic scar. The goals are to determine the recommended Phase 2 dose, the pharmacokinetics and pharmacidynamics parameters, and conduct analysis of biomarkers common to the scar formation pathway.
Detailed Description
This single-center, randomized, double-blind, within-subject placebo controlled study is designed to evaluate the safety and efficacy of various doses of STP705 administered as intradermal injection in subjects with linear hypertrophic scar.
Twenty four subjects will be divided equally among 3 cohorts (20, 30 and 40 μg/cm2/day dose level) of 8 subjects each. Each subject will receive both active (STP705) and control (Placebo) treatment twice a week for a total of 4 weeks. The total length of linear hypertrophic scar will be divided equally for treatment with STP705 and placebo. STP705 and Placebo will be injected intradermal every 1 cm length on the hypertrophic scar.
Subjects will be confined to clinic or research unit for 24 hours post-dosing after the first treatment administration for the serial PK assay and the blood sample will be collected at the following post-dosing times: 30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs, 5hrs, 6 hrs, 8 hrs, 12 hrs, 16 hrs, 24 hrs, 32 hrs and 36 hrs. Post-dosing ECG will be performed 6 hours (±1 hr) after the first study drug administration and vital signs will be monitored every 2h till 12h post-administration. Adverse events and medications will be monitored throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Scar
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STP705
Arm Type
Active Comparator
Arm Description
Each subject will receive both active (STP705) and control (Placebo) intradermal injection twice a week for a total of 4 weeks at 20 μg/cm2/day (in Cohort A), 30 μg/cm2/day (in Cohort B) and 40 μg/cm2/day (in cohort C). The total length of linear hypertrophic scar will be divided equally for treatment with STP705 and placebo. STP705 and Placebo will be injected intradermal every 1 cm length on the hypertrophic scar.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Each subject will receive both active (STP705) and control (Placebo) intradermal injection twice a week for a total of 4 weeks at 20 μg/cm2/day (in Cohort A), 30 μg/cm2/day (in Cohort B) and 40 μg/cm2/day (in cohort C). The total length of linear hypertrophic scar will be divided equally for treatment with STP705 and placebo. STP705 and Placebo will be injected intradermal every 1 cm length on the hypertrophic scar
Intervention Type
Drug
Intervention Name(s)
STP705
Other Intervention Name(s)
COTSIRANIB
Intervention Description
The Cotsiranib drug substance is composed of two siRNA oligonucleotides, targeting TGF-β1 and Cox-2 mRNA respectively, and formulated in nanoparticles with Histidine-Lysine co-Polymer (HKP) peptide at a ratio of 1:4 in mass weight (siRNA:peptide), which is further formulated into a dry powder drug product. The administration route would be intra-dermal injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal Saline
Primary Outcome Measure Information:
Title
Differences among the 3 dosage Groups in 24 Patients' appearance of the scar from baseline evaluated by Patient and Observer Scar Assessment Scale (POSAS)
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
Change in appearance of the scar from baseline evaluated by Physician Global Assessment using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS) at T4, T8, FU1, FU2 and FU3 visits.
Description
Physician global assessment will be performed using the overall opinion question of the POSAS scale. Physicians will be asked to rate the severity of the participant's scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within participant treatment difference from baseline will be assessed separately for Site A and Site B.
Time Frame
32 weeks
Title
Change in appearance of the scar from baseline evaluated by Physician Scar Assessment using Complete Patient and Observer Scar Assessment Scale (POSAS) at T4, T8, FU1, FU2 and FU3 visits.
Description
Within participant treatment difference from baseline will be assessed separately for Site A and Site B.
Time Frame
32 weeks
Title
Change in appearance of the scar from baseline evaluated by Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at T4, T8, FU1, FU2 and FU3 visits
Description
Patient global assessment was performed using the overall opinion question of the POSAS scale.
Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin). Within participant treatment difference from baseline will be assessed separately for Site A and Site B.
Time Frame
32 weeks
Title
Change in volume/size of the scar from baseline evaluated by volumetric measurement using 3D camera at T4, T8, FU1, FU2 and FU3 visits
Description
Within participant treatment difference from baseline will be assessed separately for Site A and Site B.
Time Frame
32 weeks
Other Pre-specified Outcome Measures:
Title
Safety and Tolerability as measured by adverse events (AEs) and clinically relevant changes in laboratory values, vital signs, electrocardiograms (ECGs), and physical examination variables
Time Frame
32 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is able to understand and willing to conform to the study procedures and has signed the informed consent form (ICF).
Subject is male or female, between the ages of 18 and 60 years, inclusive.
Subject with a hypertrophic scar that meet all of the following criteria:
linear scar, ≥5 to ≤40 cm in length (Cohort A), ≥5 to ≤50 cm in length (Cohort B), ≥5 to ≤60 cm in length (Cohort C)
present for minimum 6 months and no greater than 24 months
located anywhere in the body except on the face or front of neck
resulting from surgical or traumatic injury
Subject is judged, by the Investigator, to be healthy as evidenced by lack of clinically significant abnormal findings on medical history, physical examination, electrocardiogram, vital signs, and clinical laboratory tests.
Subject is willing and able to complete the entire course of the trial and to comply with the trial instructions.
Subject, if female of child-bearing potential, has a negative serum pregnancy test at screening and a negative urine pregnancy test at prior to treatment and willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) throughout the study.
Exclusion Criteria:
Subjects identified as having keloid or burn scars
Subjects who are positive for hepatitis B surface antigen (HbsAg), hepatitis C antibody and HIV.
Concurrent use of corticosteroids (including inhaled steroids) and COX-2 inhibitors
Are immuno-compromised (HIV infected, cancer and other disease affecting the basal immune response)
Clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the Investigator, not stabilized or may otherwise impact the results of the study.
Known allergy or hypersensitivity to the study drug(s) or one of the ingredients of the formulation.
Any infection or wound in the area to treat.
Female subjects who are pregnant or breast-feeding.
Participation in a clinical study involving administration of an investigational compound within the past 30 days.
Existence of any surgical, medical or laboratory condition that, in the judgment of the clinical investigator, might interfere with the safety, distribution, metabolism or excretion of the drug.
Facility Information:
Facility Name
WCCT Global
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Randomized Study to Evaluate the Safety and Efficacy of Various Doses of STP705 in Subjects With Hypertrophic Scar
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