Clinical Trial: A Randomized Study to Evaluate the Safety and Efficacy of Various Doses of STP705 in Subjects With Hypertrophic Scar

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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 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.

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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. [ Time Frame: 32 weeks ]
  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. [ Time Frame: 32 weeks ]
  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 [ Time Frame: 32 weeks ]

  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 [ Time Frame: 32 weeks ]
  Within participant treatment difference from baseline will be assessed separately for Site A and Site B.

Original Secondary Outcome: Same as current

Information By: Sirnaomics

Dates:
Date Received: October 31, 2016
Date Started: November 2016
Date Completion: January 2018
Last Updated: November 10, 2016
Last Verified: November 2016