Clinical Research Directory
Browse clinical research sites, groups, and studies.
Pilot Study of ELK-003 Eye Drops for Treating Ocular Manifestations of Epidermolysis Bullosa
Sponsor: Fundación DEBRA Chile, Niños Piel de Cristal
Summary
This study consists of two phases: an Observational Phase to evaluate the natural history of ocular manifestations in subjects with Dystrophic and Junctional Epidermolysis Bullosa, followed by a Treatment Phase to assess the effects of ELK-003 eye drops. Each subject will serve as their own control by comparing ocular manifestations documented during the Observational Phase to those recorded during the Treatment Phase.
Official title: Pilot, Non-Randomized, Open-Label Study to Determine the Effect of Topical ELK (ELK-003) Eye Drops Applied 6 Times Daily on Ocular Signs and Symptoms in Patients With Junctional and Dystrophic Subtypes of Epidermolysis Bullosa. Estudio Piloto, no Randomizado y Abierto Para Determinar el Efecto de Las Gotas oftalmológicas tópicas ELK Aplicadas 6 Veces al día en Los Signos y síntomas Oculares de Pacientes Con Los Subtipos de la unión y Recesivo distrófico de Epidermólisis Bulosa.
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-05-07
Completion Date
2026-06
Last Updated
2025-12-31
Healthy Volunteers
No
Conditions
Interventions
ELK-003 (Standarized Amniotic Fluid Secretome Eye Drops)
ELK-003 eye drops are a standardized amniotic fluid secretome formulation. It contains essential extracellular matrix proteins, such as collagen type VII and laminin-332, which are critical for maintaining corneal integrity in EB patients. In addition, ELK-003 also includes growth factors that stimulate corneal healing and tissue regeneration. This combination of matrix proteins and growth factors aims to enhance corneal surface stability.
Locations (1)
Fundación DEBRA Chile, Niños Piel de Cristal
Santiago, Huechuraba, Chile