Facial ScarsNCT06562023
Botulinum Toxin and Mesotherapy on Enhancement of Facial Scarring
A study testing Botulinum Toxin Type A and Mesotherapy in people with Facial Scars, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Most of the body's tissues can undergo wound repair following a disruption of tissue integrity. Upon healing, these wounds result in scar formation. The scars widen when the overlying musculature pulls apart suture lines. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Facial Scars
- What is being tested?
- Botulinum Toxin Type A and Mesotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Nov 2022to 20 Jul 2024
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient suffering from vertical or oblique forehead lacerations caused by trauma.
- Recent and fresh wounds.
- Atrophic scar (linear scar).
Who cannot join
- Infected wound.
- Patient on chemotherapy treatment and history of malignancy.
- Patients suffering from burns on the forehead or complicated lacerations.
- Allergy to drugs used in this study
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Alexandria
About this study
Official title: Botulinum Toxin Versus Mesotherapy on Enhancement of Facial Scarring (A Randomized Controlled Clinical Trial)
Most of the body's tissues can undergo wound repair following a disruption of tissue integrity. Upon healing, these wounds result in scar formation. The scars widen when the overlying musculature pulls apart suture lines. Botulinum Toxin A (BTA) is known to prevent fibroblast proliferation and it also induces temporary muscle paralysis. Also, mesotherapy is the non-invasive transdermal injection which can aid the skin to increase collagen and elastin production. Thus, both techniques are eligible for enhancement of facial scars.
- Conditions
- Facial Scars
- Being tested
- Botulinum Toxin Type A, Mesotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will receive BTA injection within a period of 5 days after primary closure.
MesotherapyOther
Patients will receive mesotherapy growth factor serum with a derma pen within a period of 5 days after primary closure.
| Study group | Role | What they receive |
|---|---|---|
| BTA injection | Experimental | Not described Receives: Other: Botulinum Toxin Type A |
| Mesotherapy | Experimental | Not described Receives: Other: Mesotherapy |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scar appearance
The Vancouver Scar Scale (VSS) will be measured to calculate scar appearance. The VSS evaluates four indicators: vascularity, pigmentation, pliability, and height. It has a score ranging from 0-13.
- Vascularity: Normal 0, Pink 1, Red 2, Purple 3
- Pigmentation: Normal 0, Hypopigmentation 1, Hyperpigmentation 2
- Pliability: Normal 0, Supple 1, Yielding 2, Firm 3, Ropes 4, Contracture 5
- Height: Flat (0), < 2 mm (1), 2-5 mm (2), > 5 mm (3)
Measured: Baseline, 1 month, 3 months, 6 months
Change in wound width
The mean wound width will be measured using a graduated Vernier caliper
Measured: Baseline, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start19 Nov 2022
- Primary completion20 Jul 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial ScarsStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562023
- Sponsor's protocol ID
- 0926-5/2024
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Versus Mesotherapy on Enhancement of Facial Scarring (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06562023
- Acronym / sponsor ID
- 0926-5/2024
- Conditions
- Facial Scars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 19 Nov 2022 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 20 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.
Most of the body's tissues can undergo wound repair following a disruption of tissue integrity. Upon healing, these wounds result in scar formation. The scars widen when the overlying musculature pulls apart suture lines. Botulinum Toxin A (BTA) is known to prevent fibroblast proliferation and it also induces temporary muscle paralysis. Also, mesotherapy is the non-invasive transdermal injection which can aid the skin to increase collagen and elastin production. Thus, both techniques are eligible for enhancement of facial scars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BTA injection | Experimental | Other: Botulinum Toxin Type A |
| Mesotherapy | Experimental | Other: Mesotherapy |
| Control | No intervention | – |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient suffering from vertical or oblique forehead lacerations caused by trauma.
- Recent and fresh wounds.
- Atrophic scar (linear scar).
Key exclusion criteria (4 listed)
- Infected wound.
- Patient on chemotherapy treatment and history of malignancy.
- Patients suffering from burns on the forehead or complicated lacerations.
- Allergy to drugs used in this study
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 |
|---|---|---|
| Botulinum Toxin Type APatients will receive BTA injection within a period of 5 days after primary closure. | Other | BTA injection |
| MesotherapyPatients will receive mesotherapy growth factor serum with a derma pen within a period of 5 days after primary closure. | Other | Mesotherapy |
Primary outcome
Change in scar appearance
Time frame: Baseline, 1 month, 3 months, 6 months
The Vancouver Scar Scale (VSS) will be measured to calculate scar appearance. The VSS evaluates four indicators: vascularity, pigmentation, pliability, and height. It has a score ranging from 0-13. * Vascularity: Normal 0, Pink 1, Red 2, Purple 3 * Pigmentation: Normal 0, Hypopigmentation 1, Hyperpigmentation 2 * Pliability: Normal 0, Supple 1, Yielding 2, Firm 3, Ropes 4, Contracture 5 * Height: Flat (0), < 2 mm (1), 2-5 mm (2), > 5 mm (3)
Change in wound width
Time frame: Baseline, 1 month, 3 months, 6 months
The mean wound width will be measured using a graduated Vernier caliper
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin Type A and Mesotherapy in people with Facial Scars, run by Hams Hamed Abdelrahman 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 3 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: finished, as of the sponsor's last update on 20 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scar appearance (time frame: Baseline, 1 month, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2024.