Post-acne Atrophic ScarsPhase 2NCT06770608
Various Procedural Treatment Options for Post-acne Atrophic Scars
A Phase 2 study testing micro-needling with topical human actrapid insulin and Micro-needling with topical Platelet rich plasma in people with Post-acne Atrophic Scars, run by Sheikh Zayed Medical College at 1 site in Pakistan.
Trial summary
Post acne scars are formed as a result of very inflamed and nodulocystic acne. Most common type of acne scars are atrophic scars and they are further classified on the basis of depth and size of destruction into ice pick, boxcar and rolling scars. Read more about this study
- Who is it for?
- Ages 13 to 50 years
- Conditions the study is for
- Post-acne Atrophic Scars
- What is being tested?
- micro-needling with topical human actrapid insulin and Micro-needling with topical Platelet rich plasma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2025to Apr 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 13 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 13-50 years
- Gender: both male and female
- Type of acne scar: Atrophic acne scar
- Patients not taking prior treatment in last 1-2 months
Who cannot join
- Pregnancy and lactating females
- Bleeding disorders
- Platelet count less than 100000
- Hypersensitivity to insulin, PRP
- Keloidal tendency
- Active herpes simples, warts and molluscum contagiosum
- Unrealistic expectations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Sheikh zayed Medical College and Hospital
Rahim Yar Khan, Punjab Province, 644200
Sheikh zayed Medical college SZMC/H, +92689230168, info@szmc.edu.pk
About this study
Official title: Comparison of Outcome of Microneedling With Autologous Platelet Rich Plasma Verses Microneedling With Topical Insulin in the Treatment of Post-Acne Atrophic Scars
Post acne scars are formed as a result of very inflamed and nodulocystic acne. Most common type of acne scars are atrophic scars and they are further classified on the basis of depth and size of destruction into ice pick, boxcar and rolling scars. Evaulating the most efficacious, safe and affordable treatment option is the need of the hour. This study is going to compare the efficacy of microneedling with autologous platelet rich plasma verses microneedling with topical insulin in the treatment of post-acne atrophic scars as to find out the relatively more effective and safer treatment.
Read the detailed description
Acne vulgaris is a disease involving inflammation or blockage of pilosebaceous units. Post acne scars are formed as a result of very inflamed and nodulocystic acne. There are many procedures to treat post-acne scar including lasers, platelet rich plasma, fillers, chemical peeling, pulsed dye lasers, fractional CO2 lasers, subcision and punch techniques, but almost lead to additional scaring and pigmentation.The major purpose of our study is comparison of outcome of micro-needling and platelet rich plasma as opposed to combining it with topical in atrophic scars due to acne, as topical insulin is natural component of body, cheap, easy to use, minimally invasive and a new therapy for post-acne scars. No local study was found in literature research. Hence, any effect of this potentially very effective therapeutic modality needs to be investigated.
OBJECTIVE: "To compare the outcome of microneedling with autologous platelet rich plasma verses microneedling with topical insulin in the treatment of post-acne atrophic scars".
Material \& Methods: This randomized comarative study will be carried out in Outpatient Dermatology Department, Sheikh Zayed Hospital Rahim Yar Khan, Pakistan. Approval of the study has been taken from ethical review committee of the hospital.Data will be collected on prescribed form. Patient will be selected on basis of inclusion \& exclusion criteria. Informed consent will be taken from selected patients before data collection. Study will includes 60 patients which will be divided into 2 groups A \& B, 30 in each group. Group A will receive micro-needling with topical application of 2ml of human actrapid insulin. Group B will receive micro-needling with topical application of 2ml Platelet rich plasma. Face of the patient will be washed after 30 mints and patients will be strictly instructed regarding sun protection at least 1 day after the procedure. Blood glucose level will be checked prior to and 30 mints following procedure.
At monthly interval for total 4 sessions and follow up visit will be after 2 months of last session.Data will be analyzed by SPSS v25.0.
Chi-square test will be applied for qualitative variables and t-test will be used for quantitative variables.
- Conditions
- Post-acne Atrophic Scars
- Being tested
- micro-needling with topical human actrapid insulin, Micro-needling with topical Platelet rich plasma
- Keywords
- Microneedling, Autologous platelet rich plasma, Topical insulin, Post-acne atrophic scars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro-needling with topical human actrapid insulinProcedure or surgery
Micro-needling with topical application of 2ml of human actrapid insulin once monthly for 4 months
Micro-needling with topical Platelet rich plasmaProcedure or surgery
Micro-needling with topical application of 2ml Platelet rich plasma once monthly for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Micro-needling with topical human actrapid insulin group (Group A) | Active comparator | Patients with post-acne atrophic scars will receive micro-needling with topical application of 2ml of human actrapid insulin Receives: Procedure: micro-needling with topical human actrapid insulin |
| Micro-needling with topical Platelet rich plasma(Group B) | Active comparator | Patients with post-acne atrophic scars will receive micro-needling with topical application of 2ml Platelet rich plasma Receives: Procedure: Micro-needling with topical Platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the outcome of microneedling with autologous platelet rich plasma verses microneedling with topical insulin in the treatment of post-acne atrophic scars
Efficacy will be assesssed clinically at each follow up visit. Final efficacy of each treatment will be determined at last follow up visit( i.e. at 6th month after start of treatment).The final efficacy will be divided into following groups on the basis of clinical resolution of disease: 1.Remission: It is defined as complete resolution of all scar leaving behind normal skin. 2.Improvement: It is defined as a more than 50% healing of scars ,as clinically measured by the surface area from the baseline. 3.No improvement: It is defined as less than a 50% improvement in the healing of scars, as measured clinically by the surface area from the baseline.
Measured: Clinical assessment for efficacy will be done monthly for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-acne Atrophic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohibullah Zahidi, Sheikh Zayed Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770608
- Sponsor's protocol ID
- sheikh-ZMC
- Status last verified
- Dec 2024
- First submitted
- 31 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcome of Microneedling With Autologous Platelet Rich Plasma Verses Microneedling With Topical Insulin in the Treatment of Post-Acne Atrophic Scars
- ClinicalTrials.gov ID
- NCT06770608
- Acronym / sponsor ID
- sheikh-ZMC
- Conditions
- Post-acne Atrophic Scars
- Keywords
- Microneedling, Autologous platelet rich plasma, Topical insulin, Post-acne atrophic scars
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- Jan 2025 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 13 Jan 2025 (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 formed as a result of very inflamed and nodulocystic acne. Most common type of acne scars are atrophic scars and they are further classified on the basis of depth and size of destruction into ice pick, boxcar and rolling scars. Evaulating the most efficacious, safe and affordable treatment option is the need of the hour. This study is going to compare the efficacy of microneedling with autologous platelet rich plasma verses microneedling with topical insulin in the treatment of post-acne atrophic scars as to find out the relatively more effective and safer treatment.
Detailed description
Acne vulgaris is a disease involving inflammation or blockage of pilosebaceous units. Post acne scars are formed as a result of very inflamed and nodulocystic acne. There are many procedures to treat post-acne scar including lasers, platelet rich plasma, fillers, chemical peeling, pulsed dye lasers, fractional CO2 lasers, subcision and punch techniques, but almost lead to additional scaring and pigmentation.The major purpose of our study is comparison of outcome of micro-needling and platelet rich plasma as opposed to combining it with topical in atrophic scars due to acne, as topical insulin is natural component of body, cheap, easy to use, minimally invasive and a new therapy for post-acne scars. No local study was found in literature research. Hence, any effect of this potentially very effective therapeutic modality needs to be investigated.
OBJECTIVE: "To compare the outcome of microneedling with autologous platelet rich plasma verses microneedling with topical insulin in the treatment of post-acne atrophic scars".
Material \& Methods: This randomized comarative study will be carried out in Outpatient Dermatology Department, Sheikh Zayed Hospital Rahim Yar Khan, Pakistan. Approval of the study has been taken from ethical review committee of the hospital.Data will be collected on prescribed form. Patient will be selected on basis of inclusion \& exclusion criteria. Informed consent will be taken from selected patients before data collection. Study will includes 60 patients which will be divided into 2 groups A \& B, 30 in each group. Group A will receive micro-needling with topical application of 2ml of human actrapid insulin. Group B will receive micro-needling with topical application of 2ml Platelet rich plasma. Face of the patient will be washed after 30 mints and patients will be strictly instructed regarding sun protection at least 1 day after the procedure. Blood glucose level will be checked prior to and 30 mints following procedure.
At monthly interval for total 4 sessions and follow up visit will be after 2 months of last session.Data will be analyzed by SPSS v25.0.
Chi-square test will be applied for qualitative variables and t-test will be used for quantitative variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micro-needling with topical human actrapid insulin group (Group A) | Active comparator | Procedure: micro-needling with topical human actrapid insulinPatients with post-acne atrophic scars will receive micro-needling with topical application of 2ml of human actrapid insulin |
| Micro-needling with topical Platelet rich plasma(Group B) | Active comparator | Procedure: Micro-needling with topical Platelet rich plasmaPatients with post-acne atrophic scars will receive micro-needling with topical application of 2ml Platelet rich plasma |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age: 13-50 years
- Gender: both male and female
- Type of acne scar: Atrophic acne scar
- Patients not taking prior treatment in last 1-2 months
Key exclusion criteria (7 listed)
- Pregnancy and lactating females
- Bleeding disorders
- Platelet count less than 100000
- Hypersensitivity to insulin, PRP
- Keloidal tendency
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 |
|---|---|---|
| micro-needling with topical human actrapid insulinMicro-needling with topical application of 2ml of human actrapid insulin once monthly for 4 months | Procedure or surgery | Micro-needling with topical human actrapid insulin group (Group A) |
| Micro-needling with topical Platelet rich plasmaMicro-needling with topical application of 2ml Platelet rich plasma once monthly for 4 months | Procedure or surgery | Micro-needling with topical Platelet rich plasma(Group B) |
Primary outcome
To compare the outcome of microneedling with autologous platelet rich plasma verses microneedling with topical insulin in the treatment of post-acne atrophic scars
Time frame: Clinical assessment for efficacy will be done monthly for 6 months
Efficacy will be assesssed clinically at each follow up visit. Final efficacy of each treatment will be determined at last follow up visit( i.e. at 6th month after start of treatment).The final efficacy will be divided into following groups on the basis of clinical resolution of disease: 1.Remission: It is defined as complete resolution of all scar leaving behind normal skin. 2.Improvement: It is defined as a more than 50% healing of scars ,as clinically measured by the surface area from the baseline. 3.No improvement: It is defined as less than a 50% improvement in the healing of scars, as measured clinically by the surface area from the baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing micro-needling with topical human actrapid insulin and Micro-needling with topical Platelet rich plasma in people with Post-acne Atrophic Scars, run by Sheikh Zayed Medical College at 1 site in Pakistan.
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: opening soon, as of the sponsor's last update on 13 Jan 2025. 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 Pakistan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohibullah, Post graduate resident (+923168716717, mohibzahidi.123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the outcome of microneedling with autologous platelet rich plasma verses microneedling with topical insulin in the treatment of post-acne atrophic scars (time frame: Clinical assessment for efficacy will be done monthly for 6 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 13 Jan 2025.