Topical KB111 for Hailey-Hailey Disease (early phase, kids and adults)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, early-phase trial to evaluate the safety, tolerability, and preliminary efficacy of KB111 applied to Hailey-Hailey disease lesions for 12 weeks. Up to seven participants aged 12 and older will use KB111 at home, with weekly check-ins by a researcher or designee. Efficacy will be explored through clinician assessments, patient impressions of severity, and skin biopsy analyses, along with monitoring for adverse events. A safety follow-up visit occurs four weeks after treatment ends.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The participant must have read, understood, and signed an Institutional Review Board (IRB)- approved Informed Consent Form and must be willing and able to comply with study procedures and instructions
* Aged ≥ 12 years of age at the time of informed consent/assent
* Documented clinical diagnosis of HHD with confirmed ATP2C1 variant by genetic testing
* A negative pregnancy test prior to initial dose for subjects of child-bearing potential
* If taking systemic therapies, subject must be on a stable dosing regimen 1 month prior to Screening and throughout the 12-week treatment period
* An acceptable form of contraception must be taken from the first dose (Week 1) through 3 months after the last dose of IP for subjects of childbearing potential

Exclusion Criteria:

* Participation in another clinical study or treatment with an investigational agent 30 days or 5 half-lives, whichever is longer, prior to initial dosing in Week 1
* Participant who is pregnant or nursing
* Participant who is unwilling to comply with contraception requirements per protocol (for subjects of child-bearing potential)
* Participant who is known to be non-compliant or is unlikely to comply with the requirements of the study protocol, in the opinion of the Investigator
* Presence of any dermatologic or systemic condition that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the Investigator to be incompatible with the study visit schedule or conduct

Where it's running

• Pediatric Skin Research
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Brittani Agostini
• Email: CNE@krystalbio.com
• Phone: 412-586-5830

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Does driving with UVA exposure affect facial skin hydration on the left vs right cheek in Florida drivers

  This observational study tests whether Florida women who drive more show less hydration on their left cheek (exposed to UVA through the driver-side window) compared with their right cheek.

  Recruiting IAS Skin Care · Orlando, Florida · NCT07764809

• Turning anonymous symptom descriptions into structured biological signals with OpenGenome

  This project tries to turn adults' anonymous free-text symptom descriptions submitted to OpenGenome into structured, literature-grounded biological signals using PubMed and ClinicalTrials.gov sources and a constrained reasoning model.

  Recruiting OpenGenome · Friedrichshain, State of Berlin · NCT07578610

• Safety of BG-A3004 in healthy volunteers and people with immune-mediated skin diseases

  This study will test whether single and multiple doses of the experimental drug BG-A3004 are safe and how the body handles it in healthy adults and people with immune-mediated skin diseases.

  Recruiting at 11 sites Phase 1 BeOne Medicines · Beijing, Beijing Municipality and 10 other locations · NCT07412691

• Detailed profiling of chronic inducible urticaria (symptomatic dermographism and cold urticaria)

  This project will test whether detailed biological and skin measurements can find markers to help diagnose and predict treatment response in adults with symptomatic dermographism or cold urticaria.

  Recruiting at 2 sites Centre for Human Drug Research, Netherlands · Leiden, South Holland and 2 other locations · NCT07359430

• Skin reactions from chest implantable port dressings

  This study will see how often dressings on chest implantable ports cause skin reactions in adults starting first-line chemotherapy.

  Recruiting Institut Curie · Paris and 2 other locations · NCT07158879

• Objective measurement of skin pigmentation with colorimetry and multispectral imaging

  We will test whether non-invasive imaging (colorimetry, multispectral imaging, and line-field confocal OCT) can provide reliable, objective skin pigmentation measurements for adults with healthy skin or skin conditions.

  Recruiting Leiden University Medical Center · Leiden, Leiden · NCT07091604

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.