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

N/ANot Yet RecruitingNCT07795515

Sohag University50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Striae Rubra

Interventions

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.

normal saline (0.9% NaCl)OTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients of both gender aged ≥18 years, clinically and dermoscopically diagnosed with bilateral symmetrical striae rubra (present on corresponding anatomical sites on both sides of the body with approximately symmetrical distribution and similar clinical appearance (color, width, and stage of evolution)). and willing to participate and sign informed consent Exclusion Criteria: * • Striae alba. * Pregnancy or lactation. * History of keloids or hypertrophic scars. * Active skin infection in treatment area. * Patients using other modalities of treatment for over the last 3 months. * Patients with bleeding disorders or on anticoagulant therapy. * Patients using drugs that exacerbate the striae as systemic corticosteroids in the preceding 3 months or topical corticosteroid in the preceding one month.

Locations (1)

Faculity of Medicine ,Sohag University

Sohag, Egypt

Outcomes

Primary Outcomes

Change in striae rubra severity assessed by Physician's Global Assessment-based quartile grading scale

Striae rubra severity will be assessed using a Physician's Global Assessment-based quartile grading scale, expressed as percentage response. The scale ranges from 0% to 100%, with higher values indicating a better treatment response. Responses are categorized as poor response (\<25%), mild response (25-50%), moderate response (50-75%), and excellent response (\>75%).

Time frame: At baseline and at weeks 3, 6, 9, and 12

Central Contacts

hager adel

CONTACT

01010207262 hageradel0100@gmail.com

Data from ClinicalTrials.gov

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