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NCT05671263
Genital Lichen Sclerosus - Epidemiology, Comorbidities and the Role of Vulvar and Penile Microbiome
trial in Lichen Sclerosus in 200 participants. Status unknown.
30 December 2023
Quick facts
| Lead sponsor | Region Jönköping County |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 14 January 2022 |
| Primary completion | 30 December 2023 |
| Estimated completion | 30 January 2024 |
| Sites | 1 location across Sweden |
Conditions studied
- Lichen Sclerosus — all drugs for Lichen Sclerosus →
Sponsor
Region Jönköping County — full company profile →
Who can join
18 and older, any sex, with Lichen Sclerosus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In genital LSc, three pathological processes are implicated in disease development: inflammation, sclerosis/fibrosis and neoplasia. The role of genital microbiome is still to be investigated and explained. Genital LSc microbiome studies are missing. The ecological community of microorganisms that are present on our body and of the body itself defines the human skin microbiome. Revealing the genital microbiome may potentially lead to new therapies of genital LSc. The primary aim is to analyze genital microbiome before and after the treatment (topical corticosteroids or topical calcineurin inhibitors or circumcision) in both male and female patients diagnosed with genital LSc as well as to analyze genital microbiome in healthy (non-genital LSc) controls. 2) The secondary aim is to determine incidence and prevalence of male and female genital LSc in Sweden and its association with other diseases. The Study will be divided in two parts 1. PART A: Prospective case control study on the effect of treatment on the genital skin microbiome of patients with genital LSc and on the role of genital microbiome in treatment resistance of genital LSc 2. PART B: Swedish nationwide register-based cohort study to analyse incidence, prevalence and comorbidities of genital LSc
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The vulvar microbiome in lichen sclerosus and high-grade intraepithelial lesions.
Pagan L, Huisman BW, van der Wurff M, Naafs RGC, et al · · 2023 · cited 10× · PMID 38094635 · DOI 10.3389/fmicb.2023.1264768
Verify or expand the search:
- PubMed search for NCT05671263
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Region Jönköping County trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05671263 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Region Jönköping County
- Last refreshed: 9 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05671263.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing