Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-02-25 @ 6:31 PM
Study NCT ID:
NCT04088357
Status:
COMPLETED
Last Update Posted:
2021-06-24
First Post:
2019-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants
Sponsor:
BioMendics, LLC
Organization:
Study Overview
Official Title:
A Phase II, Closed Label, Randomized, Double Blind Study for the Treatment of Acute Induced Wounds With TolaSure Gel, 5% w/w in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
TolaSure is a topical gel for the promotion of accelerated wound healing. This phase II study will primarily assess the efficacy of TolaSure when applied to skin wounds created by punch biopsy in healthy participants. Safety, cutaneous tolerability, wound pain control, and quality of healing will also be assessed. A total of 80 healthy volunteers, males and females ages 18 years or older, will be enrolled. Subjects will be monitored for safety and efficacy until wound closure (estimation about 8 weeks) following topical administration of TolaSure.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: