Recruiting

NCT Number: NCT06544993

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Atrophic Acne Scar

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag university Hospital

Sohag, Egypt

Location status: Recruiting

Location contact

Magdy M Amin, professor

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with atrophic post-acne scars.

Exclusion criteria

Pregnancy and lactation. Ongoing infection within the targeted treatment region or active acne lesions. Skin cancer, or precancerous lesions. History of keloid formation. History of allergy to BTX. Patients with neuromuscular diseases, patients with pre-existing medical conditions that cause muscle weakness as myasthenia gravis.

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.

Treatment and study plan

Meso-botox

Drug

Micro-Botox, is a highly diluted Botulinum toxin type A

Other names: Micro-Botox

Primary outcomes

Goodman and Baron Qualitative Global Scarring Grading System:

Time frame: 6 months

Acne scarring severity will be graded before and after treatment. Grade 1 (macular) erythematous, hyper/hypopigmented flat marks; Grade 2 (mild) mild atrophy or hypertrophic scars that may not be obvious at a distance of 50cm or greater & may be covered adequately by makeup or beard hair in men; Grade 3 (moderate) moderate atrophy or hypertrophic scarring obvious at a distance of 50cm or greater, not covered by makeup or beard hair but can be flattened by manual stretching of the skin; and Grade 4 (severe) severe atrophy or hypertrophic scarring not flattened by manual stretching of the skin.

Study contacts

Contact information is provided by the study sponsor or research team.

Mariam N Latif, resident

CONTACT

[email protected]

01228732523

Reham E El Dawla, professor

CONTACT

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Aug 9, 2024
Registry last updated: Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting