NCT05897918

Brief Summary

Our aim is to evaluate the efficacy of 10% topical tranexamic acid with microneedling in treatment of facial erythema

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

2 years

First QC Date

June 1, 2023

Last Update Submit

June 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • change in facial erythema

    method of measurement by clinician erythema assessment score Description Score Clear skin with no signs of erythema 0 Almost clear; slight redness 1 Mild erythema, definite redness 2 Moderate erythema; marked redness 3 Severe erythema; fiery redness 4 by clinician erythema assesment score

    after 6 week of end point

Study Arms (1)

single group

OTHER
Drug: Tranexamic Acid 500 MG

Interventions

Each patient received treatment on both sides of the face, one side treated by micro needling with 10% topical tranexamic acid, and othert side treated by 10% topical tranexamic acid alone every 2 weeks for 3 sessions

single group

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female Patients clinical diagnosis with persistent facial erythema and telangiectasia. Co-operative patient and patients willing for the procedure

You may not qualify if:

  • active infection at the local site or recurrent herpes. bleeding disorders or anticoagulant medications scar and keloid formation. unrealistic expectations. Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azhar University

Asyut, Egypt

Location

Related Links

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
qena

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 9, 2023

Study Start

August 1, 2020

Primary Completion

August 1, 2022

Study Completion

August 30, 2022

Last Updated

June 12, 2023

Record last verified: 2023-06

Locations