NCT06729840

Brief Summary

Intralesional injection in treatment of keloid

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2024

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2025

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

December 2, 2024

Last Update Submit

December 9, 2024

Conditions

Scar, Hypertrophic

Keywords

keloids , vitamin D

Outcome Measures

Primary Outcomes (1)

  • Posas score

    patient and observer parameters will be assessed

    One session every two weeks total duration 3 months

Study Arms (3)

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

InjectionDRUG

Vitamin D , botox , tramcinolone intralesionally injected in keloid

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Both sex aged 18-60 having keloid

You may not qualify if:

  • pregnancy , lactation Skin disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university hospital

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Cicatrix, HypertrophicKeloid

Interventions

Injections

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Central Study Contacts

sama alaa, resident doctor

CONTACT

01027748791samaalaa.867@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant doesnot know injected substance
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 3 groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sohag

Study Record Dates

First Submitted

December 2, 2024

First Posted

December 11, 2024

Study Start

December 1, 2024

Primary Completion

April 1, 2025

Study Completion

May 2, 2025

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)