Evaluation of the Efficacy and Safety of Microneedling Combined With Botulinum Toxin-A Versus Meso-Botox Injection in the Treatment of Atrophic Acne Scars: A Split-face Comparative Study

Last updated: August 6, 2024
Sponsor: Sohag University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Meso-botox

Clinical Study ID

NCT06544993
soh-Med-24-07-21MS
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Post-acne scars are psychologically disappointing and therapeutically challenging condition. No standard treatment for atrophic acne scars.

Micro-Botox, is a highly diluted BTX-A which could be injected safely intra-dermally. It targets the superficial fibers of facial muscles, sweat, and sebaceous glands inducing pores shrinkage, decreasing the sebum and excessive sweating, in addition to face lifting and reducing fine wrinkles without affecting emotions, this subsequently makes the skin tighter and gives the facial skin a smooth appearance.

Also, BTX-A appears to have an inhibitory effect on fibroblasts and collagen remodeling activity, in addition to releasing muscular tension at scar edges through superficial muscle relaxation. So, it can reduce the tethering and pulling effect of the muscles surrounding the acne scars. Also, it has anti-inflammatory and angiogenesis induction effects. Therefore, micro-Botox is believed to improve acne scars.

Therefore, it will be interesting to compare the efficacy and safety of microneedling combined with BTX-A versus meso-Botox injection in the treatment of atrophic acne scars through a split-face clinical study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with atrophic post-acne scars.

Exclusion

Exclusion Criteria:

  • Pregnancy and lactation. Ongoing infection within the targeted treatment region oractive acne lesions. Skin cancer, or precancerous lesions. History of keloidformation. History of allergy to BTX. Patients with neuromuscular diseases, patientswith pre-existing medical conditions that cause muscle weakness as myastheniagravis.

Patients who underwent Botox injection, during the last 6 months. Patients who were under treatment by systemic retinoids in the previous 6 months.

Patients with a history of chemical peels or laser procedures within 6 months of the study period.

Patients with bleeding disorders.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Meso-botox
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
May 01, 2025

Connect with a study center

  • Sohag university Hospital

    Sohag, Sohag
    Egypt

    Active - Recruiting

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