Intralesional Treatment of Keloids | NCT06729840

Studies
Intralesional Treatment of Keloids

NCT06729840

Sponsor

Sohag University

Status

Recruiting

Last Update Posted

Dec 11, 2024Actual

Enrollment

45Estimated

Phase

Phase 3

Conditions

Scar, Hypertrophic

Interventions

Injection

Countries

Egypt

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2024Estimated

Primary Completion Date

Apr 1, 2025Estimated

Completion Date

May 2, 2025Estimated

First Submitted Date

Dec 2, 2024

First Submission Date that Met QC Criteria

Dec 9, 2024

First Posted Date

Dec 11, 2024Actual

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

Dec 9, 2024

Last Update Posted Date

Dec 11, 2024Actual

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

Intralesional injection in treatment of keloid

Detailed Description

Our study will include 45 patient diveded into three groups , follow up will done before each session , 3month after the last session using photographing assessment , scoring , dermoscope

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Active Comparator	Will include 15 patients will injected with vitamin D	Drug: Injection
Group 2	Active Comparator	Will include 15 patients will injected with botulinum toxin type A	Drug: Injection
Group 3	Active Comparator	Will include 15 patients will injected with triamcinolone acetonide	Drug: Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Injection	Drug	Vitamin D , botox , tramcinolone intralesionally injected in keloid	Group 1 Group 2 Group 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Posas score	patient and observer parameters will be assessed	One session every two weeks total duration 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Both sex aged 18-60 having keloid

Exclusion Criteria:

pregnancy , lactation Skin disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
sama alaa, resident doctor	Contact	01027748791		samaalaa.867@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag university hospital	Recruiting	Sohag			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 14, 2026

Condition Browse Module

MeSH Terms

ID	Term
D017439	Cicatrix, Hypertrophic
D007627	Keloid

Ancestor Terms

ID	Term
D002921	Cicatrix
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007267	Injections

Ancestor Terms

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided