NCT02655861

Brief Summary

This project will follow babies with ichthyosis over time in order to better understand the natural course of ichthyosis in infants and children and to examine how specific genetic mutations affect clinical characteristics.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2019

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

4 years

First QC Date

November 16, 2015

Last Update Submit

July 6, 2020

Conditions

Ichthyosis

Outcome Measures

Primary Outcomes (2)

  • Weight

    To assess growth, birth weight and all weights (in pounds) obtained during hospitalization and clinic visits will be recorded. The primary outcome of the study will be to determine incidence, timing and severity of "growth failure" in neonates with ichthyosis in relation to genotype at the 3 year pediatric visit. Weight of the child will primarily be used to make this determination.

    36 Months

  • Length (Height)

    To assess growth, birth length and all subsequent measures (in inches) obtained during hospitalization and clinic visits will be recorded. The primary outcome of the study will be to determine incidence, timing and severity of "growth failure" in neonates with ichthyosis in relation to genotype at the 3 year pediatric visit. Length of the child will primarily be used to make this determination.

    36 Months

Secondary Outcomes (6)

  • Weight

    Birth (baseline), 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months

  • Length (Height)

    Birth (baseline), 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months

  • Electrolyte Disturbance

    Birth (baseline), 1 month, 2 months, 3 months, 12 months, 24 months, 36 months

  • Systemic Infections

    Birth (baseline), 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, 36 months

  • Complications of Congenital Ichthyosis

    Birth (baseline), 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, 36 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Ear and Eye Conditions

    Birth (baseline), 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, 36 months

Study Arms (1)

Ichthyosis

Other: Observation

Interventions

ObservationOTHER
Ichthyosis

Eligibility Criteria

AgeUp to 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Newborns who present at or within 2 months of birth with a clinical diagnosis of ichthyosis, except for infants with a family history of ichthyosis vulgaris and infants with X-linked ichthyosis.

You may qualify if:

  • One parent must be able to understand and sign an informed consent document.
  • Newborns who present at or within 2 months of birth with a clinical diagnosis of ichthyosis.
  • Families must consent to providing DNA for genetic analysis
  • Families must agree to the intake evaluation followed by 10 follow-up evaluations, which will occur at ages 1, 2, 3, 6, 9, 12, 18, 24, and 36 months.

You may not qualify if:

  • Subjects with non-English speaking parents
  • Patients with a family history of ichthyosis vulgaris
  • Patients with X-linked ichthyosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06519, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva or blood

MeSH Terms

Conditions

Ichthyosis

Interventions

Observation

Condition Hierarchy (Ancestors)

Skin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Brittany Criaglow, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2015

First Posted

January 14, 2016

Study Start

June 1, 2015

Primary Completion

June 5, 2019

Study Completion

June 5, 2019

Last Updated

July 7, 2020

Record last verified: 2020-07

Locations

US(1)