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A Multi-center, Prospective Evaluation of Infants and Children With Congenital Ichthyosis

N/A
Waitlist Available
Led By Brittany Criaglow, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up birth (baseline), 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, 36 months
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Ichthyosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~birth (baseline), 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and birth (baseline), 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Complications of Congenital Ichthyosis
Developmental Delays
Electrolyte Disturbance
+3 more
Other study objectives
Ear and Eye Conditions

Side effects data

From 2022 Phase 3 trial • 727 Patients • NCT02085408
94%
White blood cell decreased
93%
Platelet count decreased
89%
Neutrophil count decreased
89%
Anemia
26%
Aspartate aminotransferase increased
22%
Alanine aminotransferase increased
19%
Creatinine increased
17%
Blood bilirubin increased
13%
Alkaline phosphatase increased
11%
Hypomagnesemia
9%
Febrile neutropenia
7%
Lymphocyte count decreased
4%
Lung infection
4%
Fatigue
4%
Hyperglycemia
4%
Urinary tract infection
4%
Diarrhea
2%
Investigations - Other, specify
2%
Colitis
2%
Hypoxia
2%
Pneumonitis
2%
Dyspnea
2%
Infections and infestations - Other
2%
Hyponatremia
2%
Hypokalemia
2%
Generalized muscle weakness
2%
Skin infection
2%
Eye disorders - Other, specify
2%
Pharyngitis
2%
Leukocytosis
2%
Thromboembolic event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm F (Maintenance: Decitabine)
Arm B (Induction: Clofarabine)
Arm A (Induction: Daunorubicin + Cytarabine)
Arm C (Consolidation: Cytarabine)
Arm D (Consolidation: Clofarabine)
Arm E (Maintenance: Observation)
Arm G (Transplant)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: IchthyosisExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,453 Total Patients Enrolled
1 Trials studying Ichthyosis
44 Patients Enrolled for Ichthyosis
Foundation for Ichthyosis & Related Skin Types (FIRST)UNKNOWN
Brittany Criaglow, MDPrincipal InvestigatorYale University
~2 spots leftby Jan 2026