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Evaluating the Effectiveness and Safety of Microneedling With Topical Tranexamic Acid in Treatment of Striae Rubra

NCT07795515 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-31

No results posted yet for this study

Summary

This study aims to evaluate the efficacy and safety of microneedling with topical tranexamic acid versus microneedling with placebo (normal saline) in the treatment of striae rubra.

One side of the affected area (the intervention side) will receive topical tranexamic acid at a concentration of 100 mg/mL (Kapron® ampoules, 500 mg/5 mL; Amoun Pharmaceutical Co.), followed by a microneedling session.

The contralateral side (the control side) will receive a placebo-specifically, 0.9% normal saline-followed by a microneedling session performed in the same manner as on the intervention side.

Treatment sessions will be conducted every three weeks-up to a maximum of five sessions, depending on the patient's clinical improvement-at weeks 0, 3, 6, 9, and 12, for a total treatment duration of 12 weeks

Conditions

  • Striae Rubra

Interventions

DRUG

Topical tranexamic acid

Topical tranexamic acid solution100 mg/mL (ampoule 500 mg/5 mL, Amoun Pharmaceutical Company) Microneedling will then be performed uniformly using multiple passes (horizontal, vertical, and oblique) on both sides of the affected area till erythema with pinpoint bleeding is achieved.

OTHER

normal saline (0.9% NaCl)

normal saline (0.9% NaCl) will be applied to the control side. Microneedling will then be performed uniformly using multiple passes (horizontal, vertical, and oblique) on both sides of the affected area till erythema with pinpoint bleeding is achieved

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2026-12-01
Completion
2027-06-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07795515 on ClinicalTrials.gov