Striae Rubra
Conditions
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
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.
OTHERnormal 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
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in striae rubra severity assessed by Physician's Global Assessment-based quartile grading scale | At baseline and at weeks 3, 6, 9, and 12 | 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%). |
Countries
Egypt
Contacts
CONTACThager adel
Outcome results
None listed