A Study for Safety and Efficacy Evaluation of Various Doses of STP705 in Reducing Keloid Recurrence

Keloid Clinical Trial

Official title: A Phase 2, Multi-Center, Randomized, Multiple Arm, Controlled Pilot Study to Evaluate the Safety and Efficacy of Various Doses of STP705 in Reducing Post- Keloidectomy Keloid Recurrence

Status Completed

Clinical Trial Summary

Phase 2, randomized, double-blind, multiple arm, controlled study to evaluate safety & efficacy of various doses of STP705 in reducing post Keloidectomy keloid recurrence.

Clinical Trial Description

The objective of this study isto assess the safety, tolerability, and efficacy of various doses of STP705 and placebo via intradermal injection into the keloid excision site, to prevent the recurrence of keloids following their excision.

A total of up to 60 adult subjects will be enrolled. One eligible qualifying keloid will be excised. The subjects will be randomized to receive STP705, placebo or SOC alone (no injection) for treatment of the keloidectomy excision suture line.

To be eligible, keloid scar(s) must have been present for at least one year with a target keloid area on the trunk or extremity (non-peri-orbital/-anogenital/-scalp), measures ≥0.30cm2, and be suitable for surgical excision which will result in a single wound no greater than 7cm long.

The study is divided into 3 phase: screening phase (4 weeks), Treatment phase (up to 4 weeks +/- allowed windows), Follow up phase (up to 52 weeks +/- allowed windows). ;

Related Conditions & MeSH terms

• Keloid
• Recurrence

• NCT number: NCT04844840
• Study type: Interventional
• Source: Sirnaomics
• Status: Completed
• Phase: Phase 2
• Start date: April 29, 2021
• Completion date: May 17, 2023