Hailey-Hailey DiseaseNCT05007223
Skin Microbiome Profile in Hailey-Hailey Disease
An observational study of Hailey-Hailey Disease, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
"Hailey-Hailey disease is an autosomal dominant disorder caused by a genetic defect in a calcium ATPase (ATP2C1) leading to a defect in keratinocyte adhesion. The characteristic of this disease is the involvement of intertriginous areas of the skin, which are the moist sites including the axillary vault and the… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hailey-Hailey Disease
- What is being tested?
- Doxycycline
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 May 2020to 18 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Hailey Hailey, diagnosis confirmed by histopathology or genetics at Gangnam Severance Hospital, Dermatology Department
Who may be able to join
- 1. Hailey-Hailey disease 1-1. Inclusion Criteria
- Clinically diagnosed with Hailey-Hailey as confirmed by histopathology and/or genetic analysis.
- >19 years old
- Patients who currently have lesions on the axilla and groin
- Patietns who signed the consent form and Informed Consent in Human Material Research
- 2. Normal control 2-1. Inclusion Criteria
- >19 years old
- Persions who signed the consent form and Informed Consent in Human Material Research
Who cannot join
- 1-2. Exclusion Criteria
- Patients who have used systemic steroids or antibiotics within the last 1 month
- Patients who have used local steroids or antibiotics within the last 2 weeks
- Patients who have been diagnosed with skin diseases(such as atopic dermatitis) other than Hailey-Hailey disease
- Patients who are unable to swab or who may have affect a medical condition
- Patients who have difficulty making clear decisions due to lack of decision-making ability
Show all 12Show fewer
- In addition to the above, a person who is considered inappropriate to participate in this study, such as collecting test information, based on the medical judgment of the Principal investigator or Subinvestigator.
- 2-2. Exclusion Criteria
- Persions who have skin diseases(such as atopic dermatitis) or diseases affecting the skin microbes
- Persions who have used systemic steroids or antibiotics within the last 1 month
- Patients who have used local steroids or antibiotics within the last 2 weeks
- In addition to the above, a person who is considered inappropriate to participate in this study, such as collecting test information, based on the medical judgment of the Principal investigator or Subinvestigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization and Analysis of the Skin Microbiome in Hailey-Hailey Disease
"Hailey-Hailey disease is an autosomal dominant disorder caused by a genetic defect in a calcium ATPase (ATP2C1) leading to a defect in keratinocyte adhesion. The characteristic of this disease is the involvement of intertriginous areas of the skin, which are the moist sites including the axillary vault and the inguinal crease. The composition of microbial communities is primarily dependent on the physiology of the skin site and the moist sites have distinct compositions of skin microorganisms. In addition, treatment with doxycycline is often helpful in the management of Hailey-Hailey disease. These findings suggest a role of the skin microbiome in the pathogenesis of Hailey-Hailey disease.
The purpose of this study is to characterize the skin microbiome in patients with Hailey-Hailey disease by the 16S method, to better understand the pathogenesis of the disease and to discover new therapeutic targets in the future.
Read the detailed description
Investigators will look at patients with Hailey-Hailey disease, and healthy controls.
Investigators will look at skin microbiome (Bacterial diversity and the relative abundance of major bacterial taxa) Investigators will assess this in patients with Hailey-Hailey disease before and after doxycycline and compare them to healthy controls.
- Conditions
- Hailey-Hailey Disease
- Being tested
- Doxycycline
- Medical subject headings
- Pemphigus, Benign Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
200mg/day for 28 days(Given doxycycline to patients with Hailey-Hailey disease)
| Study group | Role | What they receive |
|---|---|---|
| 1. Experimental: doxycycline | Given doxycycline and assessment of skin Receives: Drug: Doxycycline | |
| 2. No Intervention: Healthy Controls | Control subjects to assess if there is baseline difference in the skin microbiome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shannon diversity index
- Change in the bacterial diversity index of the skin microbiome in those with and without Hailey-Hailey disease.
- Change in the bacterial diversity index of the skin microbiome before and after the treatment of doxycycline in those with Hailey-Hailey disease
The diversity will be evaluated by assessing the Shannon diversity of the bacterial DNA in the skin microbiome
Measured: 1 year
Secondary outcomes (1)
OTU(Operational Taxonomic Unit)
- Change in the relative abundance of major bacterial taxa of skin microbiome in those with and without Hailey-Hailey disease
- Change in the relative abundance of major bacterial taxa of skin microbiome before and after the treatment of doxycycline in those with Hailey-Hailey disease
The representative Operational Taxonomic Unit (OTU) sequences were assigned to a taxonomy at a confidence threshold of 50% using remote desktop protocol classifier with reference to the Greengenes database. Relative abundance of OTUs based on all unique sequences was measured.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start8 May 2020
- Primary completion18 Sep 2020
- Study completion18 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hailey-Hailey DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Eun Lee, Gangnam Severance Hospital
- Investigators
- Sang Eun Lee, Principal investigator, Department of Dermatology, Gangnam Severance Hospital, Yonsei University College of Medicine,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007223
- Sponsor's protocol ID
- 3-2020-0106
- Status last verified
- Aug 2021
- First submitted
- 5 Aug 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Analysis of the Skin Microbiome in Hailey-Hailey Disease
- ClinicalTrials.gov ID
- NCT05007223
- Acronym / sponsor ID
- 3-2020-0106
- Conditions
- Hailey-Hailey Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 8 May 2020 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 18 Sep 2020 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"Hailey-Hailey disease is an autosomal dominant disorder caused by a genetic defect in a calcium ATPase (ATP2C1) leading to a defect in keratinocyte adhesion. The characteristic of this disease is the involvement of intertriginous areas of the skin, which are the moist sites including the axillary vault and the inguinal crease. The composition of microbial communities is primarily dependent on the physiology of the skin site and the moist sites have distinct compositions of skin microorganisms. In addition, treatment with doxycycline is often helpful in the management of Hailey-Hailey disease. These findings suggest a role of the skin microbiome in the pathogenesis of Hailey-Hailey disease.
The purpose of this study is to characterize the skin microbiome in patients with Hailey-Hailey disease by the 16S method, to better understand the pathogenesis of the disease and to discover new therapeutic targets in the future.
Detailed description
Investigators will look at patients with Hailey-Hailey disease, and healthy controls.
Investigators will look at skin microbiome (Bacterial diversity and the relative abundance of major bacterial taxa) Investigators will assess this in patients with Hailey-Hailey disease before and after doxycycline and compare them to healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Experimental: doxycycline | – | Drug: DoxycyclineGiven doxycycline and assessment of skin |
| 2. No Intervention: Healthy Controls | – | –Control subjects to assess if there is baseline difference in the skin microbiome |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Hailey Hailey, diagnosis confirmed by histopathology or genetics at Gangnam Severance Hospital, Dermatology Department
Key inclusion criteria (8 listed)
- 1. Hailey-Hailey disease 1-1. Inclusion Criteria
- Clinically diagnosed with Hailey-Hailey as confirmed by histopathology and/or genetic analysis.
- >19 years old
- Patients who currently have lesions on the axilla and groin
- Patietns who signed the consent form and Informed Consent in Human Material Research
Key exclusion criteria (12 listed)
- 1-2. Exclusion Criteria
- Patients who have used systemic steroids or antibiotics within the last 1 month
- Patients who have used local steroids or antibiotics within the last 2 weeks
- Patients who have been diagnosed with skin diseases(such as atopic dermatitis) other than Hailey-Hailey disease
- Patients who are unable to swab or who may have affect a medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxycycline200mg/day for 28 days(Given doxycycline to patients with Hailey-Hailey disease) | Drug | 1. Experimental: doxycycline |
Primary outcome
Shannon diversity index
Time frame: 1 year
1. Change in the bacterial diversity index of the skin microbiome in those with and without Hailey-Hailey disease. 2. Change in the bacterial diversity index of the skin microbiome before and after the treatment of doxycycline in those with Hailey-Hailey disease The diversity will be evaluated by assessing the Shannon diversity of the bacterial DNA in the skin microbiome
1 secondary outcome
OTU(Operational Taxonomic Unit)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Eun Lee principal investigator
Department of Dermatology, Gangnam Severance Hospital, Yonsei University College of Medicine,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hailey-Hailey Disease, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shannon diversity index (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.