Atrophic Acne ScarNCT06544993
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
A study testing Meso-botox in people with Atrophic Acne Scar, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophic Acne Scar
- What is being tested?
- Meso-botox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with atrophic post-acne scars.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Reham E El Dawla, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag, Sohag
Magdy M Amin, professor
About this 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.
Read more
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
- Being tested
- Meso-botox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meso-botoxDrug
Also called Micro-Botox
Micro-Botox, is a highly diluted Botulinum toxin type A
| Study group | Role | What they receive |
|---|---|---|
| right side of face | Active comparator | meso-Botox injection Receives: Drug: Meso-botox |
| left side of face | Active comparator | microneedling combined with Botulinum toxin-A Receives: Drug: Meso-botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 May 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrophic Acne ScarStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Nashaat latif, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544993
- Sponsor's protocol ID
- soh-Med-24-07-21MS
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36169570Fabi 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.
PubMed 36857534Jung 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.
PubMed 33686358Ebrahim 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.
PubMed 35942010
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06544993
- Acronym / sponsor ID
- soh-Med-24-07-21MS
- Conditions
- Atrophic Acne Scar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| right side of face | Active comparator | Drug: Meso-botoxmeso-Botox injection |
| left side of face | Active comparator | Drug: Meso-botoxmicroneedling combined with Botulinum toxin-A |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with atrophic post-acne scars.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meso-botoxAlso: Micro-BotoxMicro-Botox, is a highly diluted Botulinum toxin type A | Drug | left side of face, right side of face |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 36169570Mohamed 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.
- Background: PubMed 36857534Fabi 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.
- Background: PubMed 33686358Jung 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.
- Background: PubMed 35942010Ebrahim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reham E El Dawla, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meso-botox in people with Atrophic Acne Scar, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam N Latif, resident (01228732523, mariam_nashaat_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goodman and Baron Qualitative Global Scarring Grading System: (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06544993, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.