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

NCT07795515 | Not Yet Recruiting

• 1 other identifier: Soh-Med-26-8-5MS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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%).

  At baseline and at weeks 3, 6, 9, and 12

Study Arms (2)

Microneedling plus topical tranexamic acid

ACTIVE COMPARATOR

Participants will receive microneedling followed by topical application of tranexamic acid to the affected striae rubra areas every 3 weeks for a maximum of five sessions.

Drug: Topical tranexamic acid

Microneedling plus topical normal saline

PLACEBO COMPARATOR

Participants will receive microneedling followed by topical application of normal saline to the affected striae rubra areas every 3 weeks for a maximum of five sessions

Other: normal saline (0.9% NaCl)

Interventions

Topical tranexamic acid DRUG

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.

Microneedling plus topical tranexamic acid

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

Microneedling plus topical normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculity of Medicine ,Sohag University

Sohag, Egypt

Location

MeSH Terms

Interventions

Tranexamic Acid; Saline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

hager adel

CONTACT

01010207262; hageradel0100@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology Resident, Sohag General Hospital

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-08

Locations

EG (1)