ScarsNCT06021275
Microneedling With Regular Insulin Versus Microneedling Alone in Treatment of Atrophic Scars
A study testing Microneedling with topical application of regular insulin and Microneedling with topical application of saline in people with Scars and Insulin, run by Alexandria University at 1 site in Egypt.
Trial summary
Recently, few studies have attempted to test the regenerative effects of human insulin application by microneedling on atrophic scars versus other topical preparations. However, the scars were limited etiologically to acne scars. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- What is being tested?
- Microneedling with topical application of regular insulin and Microneedling with topical application of saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to Dec 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 12 to 60 years
- Atrophic scars (traumatic or surgical)
- Completely healed scars
Who cannot join
- Patients with a tendency or history of hypertrophic or keloidal scars
- Patients who received treatment for their scar in the past 3 months
- Diabetic patients or those with a history of Dysglycemia
- Pregnant, or lactating females
- Patients with active infection at the site of scar
- Patients currently receiving isotretinoin treatment or in the past month
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University, Faculty of Medicine
Alexandria
Dalia I Halwag, PhD, MD, +0201224489473, daliahalwag@gmail.com
About this study
Recently, few studies have attempted to test the regenerative effects of human insulin application by microneedling on atrophic scars versus other topical preparations. However, the scars were limited etiologically to acne scars. In addition, a lack of inclusion of a control group instead of comparing topical preparations with insulin was also a limitation to these studies. A control group consisting of microneedling alone would have served as a better comparison in order to determine whether the effects of microneedling are augmented by topical protein-rich preparations.
- Being tested
- Microneedling with topical application of regular insulin, Microneedling with topical application of saline
- Keywords
- Insulin, scars
- Medical subject headings
- Cicatrix, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedling with topical application of regular insulinOther
Microneeling preformed onto the scar In one group insulin will be applied while saline will be used in the second group
Microneedling with topical application of salineOther
Microneeling preformed onto the scar In one group insulin will be applied while saline will be used in the second group
| Study group | Role | What they receive |
|---|---|---|
| Microneedling with topical application of regular insulin | Active comparator | Not described Receives: Other: Microneedling with topical application of regular insulin |
| Microneedling only | Active comparator | Not described Receives: Other: Microneedling with topical application of saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Scar
According the different scar assessment scores (e.g.POSAS score - The Patient and Observer Scar Assessment Scale score, range from 6 to 60, the higher the score the worse the scar, lowering in the score denotes improvement )
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 Oct 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Ibrahim Halwag, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021275
- Sponsor's protocol ID
- Scar 1
- Status last verified
- Jul 2024
- First submitted
- 27 Aug 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol after finishing all the research and publishing the research
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedling With Regular Insulin Versus Microneedling Alone in Treatment of Atrophic Scars
- ClinicalTrials.gov ID
- NCT06021275
- Acronym / sponsor ID
- Scar 1
- Keywords
- Insulin, scars
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Sep 2023 (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.
Recently, few studies have attempted to test the regenerative effects of human insulin application by microneedling on atrophic scars versus other topical preparations. However, the scars were limited etiologically to acne scars. In addition, a lack of inclusion of a control group instead of comparing topical preparations with insulin was also a limitation to these studies. A control group consisting of microneedling alone would have served as a better comparison in order to determine whether the effects of microneedling are augmented by topical protein-rich preparations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microneedling with topical application of regular insulin | Active comparator | Other: Microneedling with topical application of regular insulin |
| Microneedling only | Active comparator | Other: Microneedling with topical application of saline |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients aged 12 to 60 years
- Atrophic scars (traumatic or surgical)
- Completely healed scars
Key exclusion criteria (6 listed)
- Patients with a tendency or history of hypertrophic or keloidal scars
- Patients who received treatment for their scar in the past 3 months
- Diabetic patients or those with a history of Dysglycemia
- Pregnant, or lactating females
- Patients with active infection at the site of scar
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 |
|---|---|---|
| Microneedling with topical application of regular insulinMicroneeling preformed onto the scar In one group insulin will be applied while saline will be used in the second group | Other | Microneedling with topical application of regular insulin |
| Microneedling with topical application of salineMicroneeling preformed onto the scar In one group insulin will be applied while saline will be used in the second group | Other | Microneedling only |
Primary outcome
Change in Scar
Time frame: 4 months
According the different scar assessment scores (e.g.POSAS score - The Patient and Observer Scar Assessment Scale score, range from 6 to 60, the higher the score the worse the scar, lowering in the score denotes improvement )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No. Study protocol after finishing all the research and publishing the research
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling with topical application of regular insulin and Microneedling with topical application of saline in people with Scars and Insulin, run by Alexandria 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 3 inclusion and 6 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 30 Jul 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 Dalia I Halwag, PhD, MD (+00201224489473, daliahalwag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Scar (time frame: 4 months). 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 30 Jul 2024.