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

NCT06544993 | Recruiting

• 1 other identifier: soh-Med-24-07-21MS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrophic Acne Scar

Outcome Measures

Primary Outcomes (1)

• Goodman and Baron Qualitative Global Scarring Grading System:

  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.

  6 months

Study Arms (2)

right side of face

ACTIVE COMPARATOR

meso-Botox injection

Drug: Meso-botox

left side of face

ACTIVE COMPARATOR

microneedling combined with Botulinum toxin-A

Drug: Meso-botox

Interventions

Meso-botox DRUG

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

Also known as: Micro-Botox

left side of face; right side of face

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with atrophic post-acne scars.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Sohag, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 36169570 BACKGROUND

• 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.

  PMID: 36857534 BACKGROUND

• 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.

  PMID: 33686358 BACKGROUND

• 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.

  PMID: 35942010 BACKGROUND

Central Study Contacts

Mariam N Latif, resident

CONTACT

01228732523; mariam_nashaat_post@med.sohag.edu.eg

Reham E El Dawla, professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident AT DERMATOLOGY department-sohag general hospital

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: May 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

EG (1)