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

August 6, 2024 updated by: Mariam Nashaat latif, Sohag University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Reham E El Dawla, professor

Study Locations

  • Egypt
      • Sohag, Egypt, Sohag
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: right side of face
meso-Botox injection
Drug: Meso-botox
Micro-Botox, is a highly diluted Botulinum toxin type A
Other Names:
  • Micro-Botox
Active Comparator: left side of face
microneedling combined with Botulinum toxin-A
Drug: Meso-botox
Micro-Botox, is a highly diluted Botulinum toxin type A
Other Names:
  • Micro-Botox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-Med-24-07-21MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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