Skin Microbiome Profile in Hailey-Hailey Disease
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|ClinicalTrials.gov Identifier: NCT05007223|
Recruitment Status : Completed
First Posted : August 16, 2021
Last Update Posted : August 16, 2021
"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.
|Condition or disease||Intervention/treatment|
|Hailey-Hailey Disease||Drug: Doxycycline|
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 Type :||Observational|
|Actual Enrollment :||18 participants|
|Official Title:||Characterization and Analysis of the Skin Microbiome in Hailey-Hailey Disease|
|Actual Study Start Date :||May 8, 2020|
|Actual Primary Completion Date :||September 18, 2020|
|Actual Study Completion Date :||September 18, 2020|
1. Experimental: doxycycline
Given doxycycline and assessment of skin
200mg/day for 28 days(Given doxycycline to patients with Hailey-Hailey disease)
2. No Intervention: Healthy Controls
Control subjects to assess if there is baseline difference in the skin microbiome
- Shannon diversity index [ Time Frame: 1 year ]
- 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
- OTU(Operational Taxonomic Unit) [ Time Frame: 1 year ]
- 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.
Biospecimen Retention: Samples Without DNA
- Case (HHD) 1) Axillar active lesion 2) Axillar healed lesion 3) Inguinal active lesion 4) Inguinal healed lesion
- Control (NC) 1) Axillar area 2) Inguinal area
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05007223
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Principal Investigator:||Sang Eun Lee||Department of Dermatology, Gangnam Severance Hospital, Yonsei University College of Medicine,|