CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 35 enrolled
Drug / intervention
TCP-25 gel 0.86 mg/ml or placebo gel +2 moredrug
Likely dose
TCP-25 gel 0.86 mg/ml or placebo gelfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05378997
NCT05378997Phase 1Completed
CompareCT.gov

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Male and Female Volunteers to Investigate the Safety, Tolerability, and Pharmacokinetics of Ascending Topical Doses of TCP-25 Applied to Epidermal Suction Blister Wounds and in Patients With Non-Healing Leg Ulcers and Patients With Dystrophic Epidermolysis Bullosa

Xinnate AB·interventional·Posted May 18, 2022·Updated Mar 26, 2024

In Brief

A Phase 1 clinical trial evaluating TCP-25 gel 0.86 mg/ml or placebo gel, TCP-25 gel 2.9 mg/ml or placebo gel, and 1 other intervention for Blister and 3 related conditions. Completed, enrolled 35 participants across 1 site.

Detailed Summary

This is a three-part, Phase I, first-in-human study designed to evaluate the safety, tolerability, and potential systemic exposure of multiple topical doses of TCP-25. Part I includes healthy volunteers with acute epidermal wounds formed by the suction blister technique. Part II includes patients with non-healing leg ulcers and Part III patients with dystrophic epidermolysis bullosa (DEB).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlister, Wound of Skin, Epidermolysis Bullosa, Varicose Ulcer of Lower Limb
CountriesSweden
CollaboratorsRegion Skane

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedMay 18, 2022
Enrollment StartApr 7, 2022
Primary CompletionMar 16, 2024
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.1 years ago

Interventions

TCP-25 gel 0.86 mg/ml or placebo geldrug

TCP-25 gel (0.86 mg/mL) applied to two wounds per patient and placebo gel applied to two wounds per patient

TCP-25 gel 2.9 mg/ml or placebo geldrug

TCP-25 gel (2.9 mg/mL) applied to two wounds per patient and placebo gel applied to two wounds per patient

TCP-25 gel 8.6 mg/ml or placebo geldrug

TCP-25 gel (8.6 mg/mL) applied to two wounds per patient and placebo gel applied to two wounds per patient