Recruiting

Observational Study

Sponsor:

Krystal Biotech, Inc.

Code:

NCT06563414

Conditions

Epidermolysis Bullosa Dystrophica

Epidermolysis Bullosa Dystrophica, Recessive

Epidermolysis Bullosa Dystrophica Dominans

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief 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).

Conditions

Epidermolysis Bullosa Dystrophica

Epidermolysis Bullosa Dystrophica, Recessive

Epidermolysis Bullosa Dystrophica Dominans

Study ID

NCT06563414

Start date

Aug 2, 2024

Status verified date

Jul, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Corneal abrasion frequency [ Time Frame: Baseline through up to 1 year ]

Central Contacts and Locations

Central contacts

David Chien, MD

412-586-5830dchien@krystalbio.com

Brittani Agostini, RN, CCRC

412-586-5830bagostini@krystalbio.com

Locations

Krystal Biotech

Recruiting

Pittsburgh, Pennsylvania, United States, 15203

Contacts

Brittani Agostini

412-586-5830debeyestudy@krystalbio.com

More Information

Sponsor

Krystal Biotech, Inc.

Last update posted

Jul 2, 2025

Last verified

Jul, 2025

Keywords

  • Dystrophic Epidermolysis Bullosa
  • DEB
  • Corneal Abrasions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Krystal Biotech, Inc. on 2025-07-02.