Growth Hormone in EB | NCT05390073

Studies
Growth Hormone in EB

NCT05390073

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

May 25, 2022Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Epidermolysis Bullosa Dystrophica

Interventions

growth hormone level and insulin like growth factor 1

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 25, 2022Estimated

Primary Completion Date

Jun 10, 2022Estimated

Completion Date

Jun 15, 2022Estimated

First Submitted Date

May 20, 2022

First Submission Date that Met QC Criteria

May 24, 2022

First Posted Date

May 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2022

Last Update Posted Date

May 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Growth is extremely affected in epidermolysis bullosa patients

Detailed Description

Studying the role of growth hormone and ILGF-1 in EB may pave the to new therapeutic modality that could improve the growth in those children and avoid the irreversible sequelae that affected subjects experience after adulthood

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
growth hormone level and insulin like growth factor 1	Diagnostic Test	laboratory test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
level of growth hormone and insulin like growth factor 1	laboratory test	2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Children with EB dystrophica

Exclusion Criteria:

Adults with the same disease

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

12 Years

Standard Ages

Child

Study Population

Children with EB dystrophica

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41287410	Derived	El Darouti M, Zaki IS, Mousa N, El Sayed H. Assessment of Growth Hormone and Insulin-Like Growth Factor 1 in Children With Epidermolysis Bullosa Dystrophica. Pediatr Dermatol. 2025 Nov 24. doi: 10.1111/pde.70113. Online ahead of print.

ID	Term
D004820	Epidermolysis Bullosa
D012868	Skin Abnormalities
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities