Skip to content

Clinical efficacy and safety of botulinum toxin type A in the treatment of Hailey Hailey: a single center, open label, randomized controlled study

Clinical efficacy and safety of botulinum toxin type A in the treatment of Hailey Hailey: a single center, open label, randomized controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102331
Enrollment
Unknown
Registered
2025-05-13
Start date
2025-01-03
Completion date
Unknown
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial benign chronic pemphigus or Haily-Haily disease

Interventions

Experimental group and control group:Type A botulinum toxin injection
control group:Traditional topical medication treatment

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.The participant shall sign the informed consent, commit to adhering to the research procedures, and actively cooperate with the complete implementation of the research process. 2.The clinical presentation and histopathological diagnosis of Hailey-Hailey disease are necessary for patients who are 18 years old and above. 3.In order to ensure the accuracy of screening results, it is recommended that fertile women use contraception for a minimum duration of one month prior to screening and commit to its consistent use throughout the study period, as well as until the specified time after completion of the study. 4.The trial was conducted without the administration of any drugs or treatments that could potentially influence the outcomes. 5.Refrain from participating in any other clinical trials at different research centers throughout the duration of the trial.

Exclusion criteria

Exclusion criteria: 1.The patients who were not able to be followed up with. 2.The patient should not receive Botox-A or its excipients if they have a documented allergy, myotonia, dysphagia, a history of dysphagia, or a previous episode of aspiration pneumonia. 3.Patients suffering from severe systemic or psychiatric disorders who are incapable of completing the questionnaire. 4.Participants were currently receiving systemic or topical corticosteroids, immunosuppressants, calcineurin inhibitors, biologics (excluding emollients or preservatives), or had received them within 7 days prior to the start of the study. 5.Botulinum toxin injections, dynamic phototherapy or laser therapy administered in the previous six months, or systemic aminoglycoside therapy received within the past two weeks. 6.A medical history of dermatological or other relevant conditions that could potentially impact the accuracy of the test results. 7.The participant must not be currently enrolled in any other clinical trial or have been enrolled within 3 months prior to the start of this study. 8.The individual is currently pregnant, lactating, or has intentions to conceive. 9.Additionally, if the study leader deems it inappropriate to conduct the test.

Design outcomes

Primary

MeasureTime frame
IGA75 remission rate (IGA improvement = 75%);

Secondary

MeasureTime frame
Doctor's Global Assessment (PGA);dermatology life quality index;

Countries

China

Contacts

Public ContactYongyong Yuan

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

yyy21203@rjh.com.cn+86 21 6437 0045

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026