Scars, HypertrophicNCT04995302
Microneedling Therapy With or Without Amnion Bilayer Sheeting on Scar Tissue
A study testing Microoneedling and Amnion Bilayer and Microoneedling in people with Scars, Hypertrophic and Burn Scar, run by Dr.dr.Irma Bernadette, SpKK (K) at 1 site in Indonesia.
Trial summary
The aim of this study is to compare the outcome of microneedling therapy with or without amnion bilayer sheeting on post-burn hypertrophic scar tissue. A clinical trial will be conducted with 17 samples, from September to December 2021. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Scars, Hypertrophic, Burn Scar
- What is being tested?
- Microoneedling and Amnion Bilayer and Microoneedling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2021to 31 Jan 2022
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Male or female patients, aged 18-50 years old
- Patients with post-burn, mature hypertrophic scars, localized in any areas other than the face, with a minimum of 5 cm in diameter.
- Patients are willing to participate in the study and sign an informed consent form
Who cannot join
- Patients with scars less than 5 cm in diameter
- Patients with scars localized solely in the face
- Hypertrophic scars with keloid
- Patients with comorbidities
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
dr. Cipto Mangunkusumo Hospital
Jakarta, Jakarta Pusat, 10430
Irma B Sitohang, MD, Ph.D, +62818130761, irma_bernadette@yahoo.com
About this study
Official title: The Comparison of Microneedling Therapy With or Without Amnion Bilayer Sheeting on Post-Burn Hypertrophic Scar Tissue
The aim of this study is to compare the outcome of microneedling therapy with or without amnion bilayer sheeting on post-burn hypertrophic scar tissue. A clinical trial will be conducted with 17 samples, from September to December 2021.
Read the detailed description
High degree burn injuries commonly result in abnormal scar formation, and therapy for this hypertrophic scar remains a challenge. For years, microoneedling has been used for treating hypertrophic scars, and an addition of amnion bilayer sheeting is expected to provide a more favorable outcome. This study aims to compare microneedling therapy with or without amnion bilayer sheeting on post-burn hypertrophic scars tissue. This is an interventional study with 17 samples, aged 18-50 years old. Therapeutic outcomes will be evaluated using visual analog scale, degree of erythema, patient's subjective evaluation, dermoscope, biopsy, and skin ultrasound.
- Conditions
- Scars, Hypertrophic, Burn Scar
- Being tested
- Microoneedling and Amnion Bilayer, Microoneedling
- Keywords
- Microneedling, Amnion bilayer, Scar
- Medical subject headings
- Cicatrix, Hypertrophic, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microoneedling and Amnion BilayerProcedure or surgery
Microneedling is conducted following a three-week application of tretinoin cream. Then, scar tissue that has been treated with microneedling is covered with amnion bilayer for 72 hours.
MicrooneedlingProcedure or surgery
Microneedling is conducted following a three-week application of tretinoin cream. Then, scar tissue that has been treated with microneedling is covered with an antibacterial gauze dressing.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling and Amnion Bilayer | Active comparator | Microneedling is a dermaroller procedure that uses small needles to prick the skin. Amnion bilayer is used as an additional therapy after microneedling therapy. Receives: Procedure: Microoneedling and Amnion Bilayer |
| Microneedling | Placebo comparator | Microneedling is a dermaroller procedure that uses small needles to prick the skin. Receives: Procedure: Microoneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Subjective Pain in one month
Using Visual Analog Scale (0-10, 0 indicates no pain and 10 indicates severe pain)
Measured: Baseline, day 7, day 30
Change in Erythema Degree in one month
Using Erythema score (0-4, 0 indicates no erythema and 4 indicates severe erythema)
Measured: Baseline, day 7, day 30
Change in Dermoscopy Evaluation in one month
Qualitative description of blood vessel structure, pigmentation density and erythema
Measured: Baseline, day 7 , day 30
Change in Biopsy Evaluation in one month
Descriptive evaluation using HE staining
Measured: Baseline, Day 7 and day 30
Change in Skin Thickness in one month
Evaluation with USG of epidermal and dermal layer (in pixels)
Measured: Baseline, Day 7 and day 30
Change in Subjective Improvement in one month
Using Patient and Observer Scar Assessment Scale (Patients scored from 1-10 in pain, itch, color, stiffness, thickness and irregularity of their scar, observer gives score on vascularity, pigmentation, thickness, relief, pliability, and surface area)
Measured: Baseline , Day 7 and day 30
Change in Subjective Improvement in one month
Using Modified Vancouver Scar Scale (Evaluating pigmentation (score 0-3), vascularity (0-3), pliability (0-5), height (0-5))
Measured: Baseline , Day 7 and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scars, HypertrophicStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In this study, one scar in one subject, will be divided into two areas, one-half of the scar will receive an intervention of microneedling, and the other half will receive microneedling+amnion bilayer. Hence, one subject will receive both interventions at the same time
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr.dr.Irma Bernadette, SpKK (K), Universitas Indonesia
- Investigators
- Irma B Sitohang, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995302
- Sponsor's protocol ID
- MicroneedlingScar
- Status last verified
- Jul 2021
- First submitted
- 21 Jul 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Microneedling Therapy With or Without Amnion Bilayer Sheeting on Post-Burn Hypertrophic Scar Tissue
- ClinicalTrials.gov ID
- NCT04995302
- Acronym / sponsor ID
- MicroneedlingScar
- Conditions
- Scars, Hypertrophic, Burn Scar
- Keywords
- Microneedling, Amnion bilayer, Scar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)University, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 6 Aug 2021 (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.
The aim of this study is to compare the outcome of microneedling therapy with or without amnion bilayer sheeting on post-burn hypertrophic scar tissue. A clinical trial will be conducted with 17 samples, from September to December 2021.
Detailed description
High degree burn injuries commonly result in abnormal scar formation, and therapy for this hypertrophic scar remains a challenge. For years, microoneedling has been used for treating hypertrophic scars, and an addition of amnion bilayer sheeting is expected to provide a more favorable outcome. This study aims to compare microneedling therapy with or without amnion bilayer sheeting on post-burn hypertrophic scars tissue. This is an interventional study with 17 samples, aged 18-50 years old. Therapeutic outcomes will be evaluated using visual analog scale, degree of erythema, patient's subjective evaluation, dermoscope, biopsy, and skin ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In this study, one scar in one subject, will be divided into two areas, one-half of the scar will receive an intervention of microneedling, and the other half will receive microneedling+amnion bilayer. Hence, one subject will receive both interventions at the same time
| Arm | Type | Receives |
|---|---|---|
| Microneedling and Amnion Bilayer | Active comparator | Procedure: Microoneedling and Amnion BilayerMicroneedling is a dermaroller procedure that uses small needles to prick the skin. Amnion bilayer is used as an additional therapy after microneedling therapy. |
| Microneedling | Placebo comparator | Procedure: MicrooneedlingMicroneedling is a dermaroller procedure that uses small needles to prick the skin. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female patients, aged 18-50 years old
- Patients with post-burn, mature hypertrophic scars, localized in any areas other than the face, with a minimum of 5 cm in diameter.
- Patients are willing to participate in the study and sign an informed consent form
Key exclusion criteria (4 listed)
- Patients with scars less than 5 cm in diameter
- Patients with scars localized solely in the face
- Hypertrophic scars with keloid
- Patients with comorbidities
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 |
|---|---|---|
| Microoneedling and Amnion BilayerMicroneedling is conducted following a three-week application of tretinoin cream. Then, scar tissue that has been treated with microneedling is covered with amnion bilayer for 72 hours. | Procedure or surgery | Microneedling and Amnion Bilayer |
| MicrooneedlingMicroneedling is conducted following a three-week application of tretinoin cream. Then, scar tissue that has been treated with microneedling is covered with an antibacterial gauze dressing. | Procedure or surgery | Microneedling |
Primary outcome
Change in Subjective Pain in one month
Time frame: Baseline, day 7, day 30
Using Visual Analog Scale (0-10, 0 indicates no pain and 10 indicates severe pain)
Change in Erythema Degree in one month
Time frame: Baseline, day 7, day 30
Using Erythema score (0-4, 0 indicates no erythema and 4 indicates severe erythema)
Change in Dermoscopy Evaluation in one month
Time frame: Baseline, day 7 , day 30
Qualitative description of blood vessel structure, pigmentation density and erythema
Change in Biopsy Evaluation in one month
Time frame: Baseline, Day 7 and day 30
Descriptive evaluation using HE staining
Change in Skin Thickness in one month
Time frame: Baseline, Day 7 and day 30
Evaluation with USG of epidermal and dermal layer (in pixels)
Change in Subjective Improvement in one month
Time frame: Baseline , Day 7 and day 30
Using Patient and Observer Scar Assessment Scale (Patients scored from 1-10 in pain, itch, color, stiffness, thickness and irregularity of their scar, observer gives score on vascularity, pigmentation, thickness, relief, pliability, and surface area)
Change in Subjective Improvement in one month
Time frame: Baseline , Day 7 and day 30
Using Modified Vancouver Scar Scale (Evaluating pigmentation (score 0-3), vascularity (0-3), pliability (0-5), height (0-5))
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Irma B Sitohang principal investigator
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microoneedling and Amnion Bilayer and Microoneedling in people with Scars, Hypertrophic and Burn Scar, run by Dr.dr.Irma Bernadette, SpKK (K) at 1 site in Indonesia.
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: status not confirmed, as of the sponsor's last update on 6 Aug 2021. 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 Indonesia. 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. Some participants in this study may receive a placebo. 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 Irma B Sitohang (+62818130761, irma_bernadette@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Subjective Pain in one month (time frame: Baseline, day 7, day 30). The study lists 7 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 6 Aug 2021.