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Topical Gel

5 Percent TolaSure Topical Gel for Epidermolysis Bullosa Simplex (TAMES Trial)

Phase 1
Waitlist Available
Research Sponsored by BioMendics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, during study (optional, estimated week 3-week 6), end of study (maximum 10 weeks)
Awards & highlights

TAMES Trial Summary

This trial will test a new gel that promises to speed up wound healing in patients with a severe skin condition.

Eligible Conditions
  • Epidermolysis Bullosa Simplex

TAMES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, during study (optional, estimated week 3-week 6), end of study (maximum 10 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, during study (optional, estimated week 3-week 6), end of study (maximum 10 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Secondary outcome measures
Investigator Global Assessment (IGA)
Keratin Aggregate Counts and Cell Morphology Assessment
Patient's-reported Itch Score of Treatment Areas
+3 more
Other outcome measures
Cytokine Content in Suction Blister Fluid
Proportion of Keratinocytes containing Autophagosomes

TAMES Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: 5 Percent TolaSure Topical GelActive Control1 Intervention
5% (w/w) TolaSure Gel
Group II: Topical Vehicle GelPlacebo Group1 Intervention
TolaSure Vehicle Gel

Find a Location

Who is running the clinical trial?

BioMendics, LLCLead Sponsor
2 Previous Clinical Trials
94 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being accepted into the experimental protocol?

"Confirmed. According to clinicaltrials.gov, this medical trial is searching for participants since it was first posted on May 5th 2022 and amended most recently on July 18th of the same year. Only five patients need to be enrolled from one centre location."

Answered by AI

Is the enrollment process for this trial currently open?

"Indeed, the info on clinicaltrials.gov demonstrates that this experiment is recruiting participants at the moment. It was initially made available to potential enrollees on May 5th 2022 and last modified on July 18th 2022. This research requires five volunteers from a single medical centre."

Answered by AI

Is 5 Percent TolaSure Topical Gel a secure substance for human use?

"With limited clinical data backing its safety and efficacy, 5 Percent TolaSure Topical Gel earned a score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Topical TolaSure Targeting Aggregated Mutant Keratin in Severe Epidermolysis Bullosa Simplex
2022. "Safety and Efficacy of Topical TolaSure Targeting Aggregated Mutant Keratin in Severe Epidermolysis Bullosa Simplex". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05062070.
~2 spots leftby Apr 2025
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