Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrophic Acne Scar
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Goodman and Baron Qualitative Global Scarring Grading System:
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: Mohamed NE, Shabaan SN, Raouf AH. Microbotox (Mesobotox) versus microneedling as a new therapeutic modality in the treatment of atrophic post-acne scars. J Cosmet Dermatol. 2022 Dec;21(12):6734-6741. doi: 10.1111/jocd.15419. Epub 2022 Oct 14.
citation: Fabi SG, Park JY, Goldie K, Wu W. Microtoxin for Improving Pore Size, Skin Laxity, Sebum Control, and Scars: A Roundtable on Integrating Intradermal Botulinum Toxin Type A Microdoses Into Clinical Practice. Aesthet Surg J. 2023 Aug 17;43(9):1015-1024. doi: 10.1093/asj/sjad044.
citation: Jung JH, Jin SG. Microneedle for transdermal drug delivery: current trends and fabrication. J Pharm Investig. 2021;51(5):503-517. doi: 10.1007/s40005-021-00512-4. Epub 2021 Mar 4.
citation: Ebrahim H, Elardi A, Khater S, Morsi H. Successful Topical Application of Botulinum Toxin After Microneedling Versus Microneedling Alone for the Treatment of Atrophic Post Acne Scars: A Prospective, Split-face, Controlled Study. J Clin Aesthet Dermatol. 2022 Jul;15(7):26-31.