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

ConditionStriae Rubra
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSohag University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

• Striae alba.

Pregnancy or lactation.

History of keloids or hypertrophic scars.

Active skin infection in treatment area.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • normal saline (0.9% NaCl)

    Other intervention

    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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Microneedling plus topical tranexamic acidActive comparator 1 intervention
Group B: Microneedling plus topical normal salinePlacebo comparator 1 intervention

Trial outcomes

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%).

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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