NCT06563414Recruiting

A Natural History Study of Corneal Abrasions in Patients With Dystrophic Epidermolysis Bullosa (DEB)

Krystal Biotech, Inc.

Start Date

8/2/2024

Completion Date

12/1/2025

Summary

This study is a non-interventional, observational study that will evaluate the natural history of corneal abrasions in patients with Dystrophic Epidermolysis Bullosa (DEB).

Detailed Description

The objective of this study is to characterize the natural history of corneal abrasions in patients with Dystrophic Epidermolysis Bullosa (DEB). Patients will be followed via remote weekly symptom diaries and monthly questionnaires to assess corneal abrasion symptoms, frequency, and duration.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: 1. The subject or their respective legal guardian must have read, understood, and signed an Institutional Review Board (IRB) approved Informed Consent/Assent Form and must be able to and willing to follow study procedures and instructions. 2. Age 6 months or older at time of Informed Consent/Assent. 3. Prior genetic diagnosis of DEB due to mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

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Conditions

Epidermolysis Bullosa DystrophicaEpidermolysis Bullosa Dystrophica, RecessiveEpidermolysis Bullosa Dystrophica Dominans

Locations

Krystal Biotech

Pittsburgh, Pennsylvania 15203

United States