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

Last updated: July 1, 2025
Sponsor: Krystal Biotech, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epidermolysis Bullosa

Treatment

N/A

Clinical Study ID

NCT06563414
NHS
  • Ages > 6
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 40
Study Start date:
August 02, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Krystal Biotech

    Pittsburgh, Pennsylvania 15203
    United States

    Active - Recruiting

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