Study of the Efficacy and Safety of Granexin® Gel to Improve Burn Wound Healing

Phase 2

Withdrawn

• Conditions: Second Degree Burn; Thermal Burn
• Interventions: Drug: Granexin® gel (200 μM); Drug: Vehicle gel

• Registration Number: NCT04684121
• Lead Sponsor: Xequel Bio, Inc.

Brief Summary

To evaluate the efficacy of Granexin® gel to promote accelerated healing of second-degree (deep partial thickness) thermal burns.

Detailed Description

Multi-center, prospective, randomized, double-blind, parallel-group, within-subject Vehicle controlled, safety and efficacy trial involving subjects with two comparable (similar body location, similar burn area and burn severity), noncontiguous deep second-degree thermal burns of less than 20% TBSA. A total of 30 subjects will have two target burns randomly assigned in a ratio of 1:1 to two treatment groups.

* Granexin® gel (200 μM) plus ACTICOAT Flex 3TM

* Vehicle gel plus ACTICOAT Flex 3TM

The study procedures are divided into the following three periods:

* Screening (within 36 hours of the time of injury)

* Treatment (daily for 10 days)

* Follow-up (Day 10 through Month 12)

The anticipated total duration of a given subject's participation in this study is 12 months. Screening can occur up to 36 hours prior to Day 0; Screening and Day 0 may occur on the same day. Treatment period visits occur daily from Day 0 through Day 9, on-site and remotely. During the treatment period, each subject will be treated with Granexin® gel (200 μM) plus ACTICOAT Flex 3TM on one target burn and Vehicle gel plus ACTICOAT Flex 3TM on the second target burn. After Day 9, the subject will return to clinic on Day 10 and be followed-up (on-site or remotely) every other day thereafter until Day 28, with on-site visits on Days 14, 20, and 28. The subject will then return to the clinic for follow-up visits at Months 6, 9, and 12.

Safety will be assessed during the study by monitoring adverse events and measuring vital signs at each on-site visit, electrocardiograms (ECG), and clinical laboratory tests at selected time points before and after treatment with Granexin® gel and Vehicle gel. Concomitant medications will be reviewed at every visit.

Study Timeline

• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-21
• Study First Posted: 2020-12-24
• Study Start: 2022-08-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-19
• Last Update Posted: 2023-06-22
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Granexin gel	Granexin® gel (200 μM)	Within-subject comparison of Granexin® Gel versus vehicle gel (placebo). Granexin® gel 200 μM will be applied daily over ten days. Granexin® will be applied to one of two selected target burns.
Vehicle Gel	Vehicle gel	Within-subject comparison of Granexin® Gel versus vehicle gel (placebo). Vehicle gel will be applied daily over ten days. Vehicle will be applied to one of two selected target burns.

Primary Outcome Measures

Name	Time	Method
Time to re-epithelization	From Day 0 to Month 12	Time (in days) to 100% re-epitheliazation of deep second degree burns as determined through clinical assessments

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects needing additional burn interventions	From Day 0 to Day 28	Determined by the initiation of burn interventions, including surgery and skin grafts
Reduction in scar severity at Month 12	Month 12	Assessed using the Vancouver Scar Scale. The Vancouver Scar Scale has 4 variables: Vascularity, Height (thickness), Pliability, Pigmentation. Each variable has three to six possible scores. The scores for the four components will be added to obtain the total score. The total score ranges from 0 to 13, whereby a score of 0 reflects normal skin.
Time to skin grafting	From Day 0 to Month 12	Determined by time (in days) to skin grafting
Incidence of treatment related adverse events (AEs)	From Day 0 to Month 12	Assessed using Common Terminology Criteria for Adverse Events (CTCAE) v 5.0. Events that are probably, possible, and definitely related will be considered treatment related events.
Proportion of burns that convert from partial thickness burns to full thickness burns	From Day 0 to Day 28	Burn conversion is determined through clinical assessment.
Incidence of infection	From Day 0 to Month 12	Determined by Investigator's assessment of presence or absence of infection