A Phase II, Placebo Controlled, Clinical Trial of Topical TolaSure Targeting Aggregated Mutant Keratin in Epidermolysis Bullosa Simplex

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

September 30, 2026

Conditions
Epidermolysis Bullosa Simplex
Interventions
DRUG

5% TolaSure Topical Gel

TolaSure Topical Gel is applied once-daily to designated treatment areas for up to 4 months (Part 2 End of Study).

DRUG

Topical Placebo Gel

Topical Placebo Gel is applied once-daily to designated treatment areas for up to 2 months (Part 1 End of Study).

Trial Locations (2)

60611

RECRUITING

NU Dermatolgy CTU, Chicago

94304

RECRUITING

Stanford University School of Medicine, Dermatology Department, Palo Alto

All Listed Sponsors
collaborator

Northwestern University Feinberg School of Medicine

OTHER

collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

collaborator

Stanford University

OTHER

collaborator

Lucile Packard Children's Hospital

OTHER

lead

BioMendics, LLC

INDUSTRY

NCT07027345 - A Phase II, Placebo Controlled, Clinical Trial of Topical TolaSure Targeting Aggregated Mutant Keratin in Epidermolysis Bullosa Simplex | Biotech Hunter | Biotech Hunter