NCT02222038

Brief Summary

The purpose of this study is to investigate the genetic architecture of Linear Localized Scleroderma (LLS) (linear morphea) by whole exome sequencing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2014

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

3.2 years

First QC Date

July 21, 2014

Last Update Submit

November 9, 2020

Conditions

Morphea

Outcome Measures

Primary Outcomes (1)

  • number of key genes /number of mutations in LLS (localized linear scleroderma)

    24-30 months

Secondary Outcomes (1)

  • the investigation of the protein network of the identified key genes in order to assess their biological function and their relevance in the pathogenesis of LLS.

    24-30 months

Study Arms (1)

skin biopsy

OTHER

4mm punch biopsy

Other: skin biopsy

Interventions

skin biopsyOTHER
skin biopsy

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects ≥ 5 years of age with well phenotyped LLS
  • Affecting their head and / or face "termed " en coup de sabre " type LLS or Hemiatrophia faciei or Parry-Romberg syndrome, with or without therapy
  • Affecting any site of the body except the head or face, with or without therapy

You may not qualify if:

  • Patients with signs of systemic scleroderma
  • Patients with localized scleroderma (morphea) other than the linear type ("plaque-type", "morphea profunda", "generalized morphea") Patients with diagnosed gadolinium induced scleroderma Patients with post-irradiation scleroderma Patients with missing consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Children's Hospital, Department of Pediatric Dermatology

Zurich, 8032, Switzerland

Location

University Hospital, Department of Dermatology

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Scleroderma, Localized

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Lisa Weibel, MD

    Department Pediatric Dermatology University Children's Hospital Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2014

First Posted

August 21, 2014

Study Start

August 1, 2014

Primary Completion

October 1, 2017

Study Completion

October 31, 2017

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations

CH(2)