New eye drops aim to soothe blistering eye pain in rare skin disease
NCT ID NCT06713434
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests whether ELK-003 eye drops can safely reduce eye symptoms in people with two types of epidermolysis bullosa (EB), a rare condition causing fragile skin and blisters. About 20 participants will first be observed without treatment, then receive the eye drops six times daily. The goal is to see if the drops decrease painful corneal abrasions and other eye problems.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Confirmed diagnosis of Recessive Dystrophic and Junctional Epidermolysis bullosa * Frequent history of corneal abrasions (one or more abrasions every 3 months) * Age: older than 2 years at the time of joining the clinical trial * Patients and/or parent/legal guardian has given written informed consent in writing Exclusion Criteria: * Acute eye infection at time of enrollment * Patients with severe vision loss (\<20/200) or severe corneal opacification. * Contact lens wear or nocturnal eye ointment * Hypersensitivity to fluorescein (ocular stain used in slit lamp study) * History of alcohol abuse or drug addiction * Patient who reports difficulty to attend the 4 in-person controls * Patients who are suffering from cancer * Patients with any medical condition or situation which in the opinion of the investigators could put the patient at risk, or could interfere with the patient's participation in the study * Pregnant or breastfeeding women (a pregnancy test will be performed using a urine sample for female patients who have had menarche).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fundación DEBRA Chile, Niños Piel de Cristal
Santiago, Huechuraba, 8580670, Chile
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