Hypertrophic ScarsNCT04389619
Fractional Microneedling RF vs Intralesional Steroid With & Without Microneedling in Hypertrophic Scars
A study testing Fractional Microneedling Radiofrequency and Intralesional Steroid Injection with and without Microneedling in people with Hypertrophic Scars, run by Cairo University at 1 site in Egypt.
Trial summary
Comparing between the effect of Fractional Microneedling Radiofrequency Versus Intralesional Steroid Injection with and without Microneedling on Tissue levels of PDGF \& CTGF in Hypertrophic Scars Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertrophic Scars
- What is being tested?
- Fractional Microneedling Radiofrequency and Intralesional Steroid Injection with and without Microneedling
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2020to Dec 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with mature hypertrophic scars.
- Patients with age above 18 years.
- Both males and females.
- Patients with two separate lesions, each 3 cm length at least OR a large sized lesion 10 cm length at least.
Who cannot join
- Patients with unrealistic expectations.
- Patients with active skin infections or autoimmune diseases.
- Non-compliant patients.
- Patients who had received any form of treatment for scars during the last six months.
- Recent use of isotretinoin within six months prior to the procedures.
- Patient with known allergy to lidocaine.
- Pregnancy \& Lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Fractional Microneedling Radiofrequency Versus Intralesional Steroid Injection With and Without Microneedling on Tissue Levels of PDGF & CTGF in Hypertrophic Scars: a Randomized Comparative Clinical Trial.
Comparing between the effect of Fractional Microneedling Radiofrequency Versus Intralesional Steroid Injection with and without Microneedling on Tissue levels of PDGF \& CTGF in Hypertrophic Scars
Read the detailed description
In each patient, each one of the two scars, or each side of a large scar will be assigned to one of the following treatment methods: 1-Fractional microneedling radiofrequency 2-Intralesional steroids injection. Scars treated with intralesional steroids will be subgrouped into two groups, one group treated with only intralesional steroids and the other group treated with intralesional steroids and followed by microneedling. Fractional microneedling radiofrequency parameters; Power: 6 v, Exposure time: 800 ms. Depth: 2.5 mm (using non-insulated micro-needles), Frequency: 2 Hz. For intralesional steroids injection, Triamcinolone acetonide will be injected in concentration 1:2 (20 mg/dl) using insulin syringe. Microneedling will be done using the same tip of the fractional microneedling radiofrequency at same depth. All patients will receive 5 treatment sessions 4 weeks apart.
- Conditions
- Hypertrophic Scars
- Being tested
- Fractional Microneedling Radiofrequency, Intralesional Steroid Injection with and without Microneedling
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional Microneedling RadiofrequencyDevice
In every patient, each one of the two scars, or each side of a large scar will be assigned to fractional microneedling radiofrequency. Fractional microneedling radiofrequency parameters; Power: 6 v, Exposure time: 800 ms. Depth: 2.5 mm (using non-insulated micro-needles), Frequency: 2 Hz for 5 treatment sessions 4 weeks apart.
Intralesional Steroid Injection with and without MicroneedlingProcedure or surgery
In every patient, each one of the two scars, or the other side of a large scar will be assigned to intralesional steroids injection, Triamcinolone acetonide will be injected in concentration 1:2 (20 mg/dl) using insulin syringe. o Scars treated with intralesional steroids will be subgrouped into two groups, one group treated with only intralesional steroids and the other group treated with intralesional steroids and followed by microneedling. Microneedling will be done using the same tip of the fractional microneedling radiofrequency at same depth. Patients will receive 5 treatment sessions 4 weeks apart.
| Study group | Role | What they receive |
|---|---|---|
| Fractional Microneedling Radiofrequency | Experimental | In every patient, each one of the two scars, or each side of a large scar will be assigned to fractional microneedling radiofrequency parameters; Power: 6 v, Exposure time: 800 ms. Depth: 2.5 mm (using non-insulated micro-needles), Frequency: 2 Hz for 5 treatment sessions 4 weeks apart. Receives: Device: Fractional Microneedling Radiofrequency |
| Intralesional Steroid Injection with and without Microneedling | Active comparator | In every patient, each one of the two scars, or the other side of a large scar will be assigned to intralesional steroids injection, Triamcinolone acetonide will be injected in concentration 1:2 (20 mg/dl) using insulin syringe. Microneedling will be done using the same tip of the fractional microneedling radiofrequency at same depth. Patients will receive 5 treatment sessions 4 weeks apart. Receives: Procedure: Intralesional Steroid Injection with and without Microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculation of patient and observer scar assessment scale (POSAS) to assess change of hyertrophic scars
Calculation of patient and observer scar assessment scale (POSAS) before every session and one month after the last session to clinically assess change of hyertrophic scars
Measured: 6 months
Photographic documentation will be performed to assess change of hypertrophic scar(s)
Photographic documentation will be performed by obtaining digital photographs for hypertrophic scar(s) before every session and one month after the last session.
Measured: 6 months
Measurement of tissue levels of both platelet derived growth factor (PDGF) & connective tissue growth factor (CTGF) to assess change of hypertrophic scars
Measurement of tissue levels of both PDGF \& CTGF to assess change of hypertrophic scars. Tissue levels of both PDGF \& CTGF will be measured by PCR in biopsies obtained from the scar areas before the treatment sessions and one month after the last session
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 posted15 May 2020
- Study start10 May 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Fathy Elmasry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389619
- Sponsor's protocol ID
- Dermatology 13
- Status last verified
- May 2020
- First submitted
- 12 May 2020
- Last updated
- 15 May 2020
- 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 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fractional Microneedling Radiofrequency Versus Intralesional Steroid Injection With and Without Microneedling on Tissue Levels of PDGF & CTGF in Hypertrophic Scars: a Randomized Comparative Clinical Trial.
- ClinicalTrials.gov ID
- NCT04389619
- Acronym / sponsor ID
- Dermatology 13
- Conditions
- Hypertrophic Scars
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 May 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 May 2020 (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.
Comparing between the effect of Fractional Microneedling Radiofrequency Versus Intralesional Steroid Injection with and without Microneedling on Tissue levels of PDGF \& CTGF in Hypertrophic Scars
Detailed description
In each patient, each one of the two scars, or each side of a large scar will be assigned to one of the following treatment methods: 1-Fractional microneedling radiofrequency 2-Intralesional steroids injection. Scars treated with intralesional steroids will be subgrouped into two groups, one group treated with only intralesional steroids and the other group treated with intralesional steroids and followed by microneedling. Fractional microneedling radiofrequency parameters; Power: 6 v, Exposure time: 800 ms. Depth: 2.5 mm (using non-insulated micro-needles), Frequency: 2 Hz. For intralesional steroids injection, Triamcinolone acetonide will be injected in concentration 1:2 (20 mg/dl) using insulin syringe. Microneedling will be done using the same tip of the fractional microneedling radiofrequency at same depth. All patients will receive 5 treatment sessions 4 weeks apart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional Microneedling Radiofrequency | Experimental | Device: Fractional Microneedling RadiofrequencyIn every patient, each one of the two scars, or each side of a large scar will be assigned to fractional microneedling radiofrequency parameters; Power: 6 v, Exposure time: 800 ms. Depth: 2.5 mm (using non-insulated micro-needles), Frequency: 2 Hz for 5 treatment sessions 4 weeks apart. |
| Intralesional Steroid Injection with and without Microneedling | Active comparator | Procedure: Intralesional Steroid Injection with and without MicroneedlingIn every patient, each one of the two scars, or the other side of a large scar will be assigned to intralesional steroids injection, Triamcinolone acetonide will be injected in concentration 1:2 (20 mg/dl) using insulin syringe. Microneedling will be done using the same tip of the fractional microneedling radiofrequency at same depth. Patients will receive 5 treatment sessions 4 weeks apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with mature hypertrophic scars.
- Patients with age above 18 years.
- Both males and females.
- Patients with two separate lesions, each 3 cm length at least OR a large sized lesion 10 cm length at least.
Key exclusion criteria (7 listed)
- Patients with unrealistic expectations.
- Patients with active skin infections or autoimmune diseases.
- Non-compliant patients.
- Patients who had received any form of treatment for scars during the last six months.
- Recent use of isotretinoin within six months prior to the procedures.
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 |
|---|---|---|
| Fractional Microneedling RadiofrequencyIn every patient, each one of the two scars, or each side of a large scar will be assigned to fractional microneedling radiofrequency. Fractional microneedling radiofrequency parameters; Power: 6 v, Exposure time: 800 ms. Depth: 2.5 mm (using non-insulated micro-needles), Frequency: 2 Hz for 5 treatment sessions 4 weeks apart. | Device | Fractional Microneedling Radiofrequency |
| Intralesional Steroid Injection with and without MicroneedlingIn every patient, each one of the two scars, or the other side of a large scar will be assigned to intralesional steroids injection, Triamcinolone acetonide will be injected in concentration 1:2 (20 mg/dl) using insulin syringe. o Scars treated with intralesional steroids will be subgrouped into two groups, one group treated with only intralesional steroids and the other group treated with intralesional steroids and followed by microneedling. Microneedling will be done using the same tip of the fractional microneedling radiofrequency at same depth. Patients will receive 5 treatment sessions 4 weeks apart. | Procedure or surgery | Intralesional Steroid Injection with and without Microneedling |
Primary outcome
Calculation of patient and observer scar assessment scale (POSAS) to assess change of hyertrophic scars
Time frame: 6 months
Calculation of patient and observer scar assessment scale (POSAS) before every session and one month after the last session to clinically assess change of hyertrophic scars
Photographic documentation will be performed to assess change of hypertrophic scar(s)
Time frame: 6 months
Photographic documentation will be performed by obtaining digital photographs for hypertrophic scar(s) before every session and one month after the last session.
Measurement of tissue levels of both platelet derived growth factor (PDGF) & connective tissue growth factor (CTGF) to assess change of hypertrophic scars
Time frame: 6 months
Measurement of tissue levels of both PDGF \& CTGF to assess change of hypertrophic scars. Tissue levels of both PDGF \& CTGF will be measured by PCR in biopsies obtained from the scar areas before the treatment sessions and one month after the last session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
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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 Fractional Microneedling Radiofrequency and Intralesional Steroid Injection with and without Microneedling in people with Hypertrophic Scars, run by Cairo 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 4 inclusion and 7 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 15 May 2020. 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?
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?
Calculation of patient and observer scar assessment scale (POSAS) to assess change of hyertrophic scars (time frame: 6 months). The study lists 3 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 15 May 2020.