Acne ScarsNCT07189923
Comparative Real-world Study on Ablative Fractional CO₂ Laser vs PRP With Microneedling for Acne Scar Treatment.
A study testing Ablative Fractional CO₂ Laser and Platelet-Rich Plasma (PRP) With Microneedling in people with Acne Scars and Ablative Fractional CO₂ Laser Therapy, run by Dr. Sirajul Islam Medical College at 1 site in Bangladesh.
Trial summary
Road traffic accidents (RTAs) remain a major public health concern worldwide and in Bangladesh, contributing significantly to injury, disability, and premature death. In resource limited settings like Bangladesh, it is crucial to understand the factors that influence survival following an RTA in order to develop… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Scars, Ablative Fractional CO₂ Laser Therapy, Platelet-rich Plasma (PRP)
- What is being tested?
- Ablative Fractional CO₂ Laser and Platelet-Rich Plasma (PRP) With Microneedling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Dec 2025to 30 Nov 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age >18 years)
- Both male and female sex
- Patients with grade 2 to grade 4 acne scars, classified on the basis of Goodman's Qualitative classification.
- Patient with equal Goodman's Qualitative scores on both halves of the face.
- No active acne lesions.
- Patients with atrophic scars only.
Who cannot join
- Positive history of keloidal tendency.
- Positive history of bleeding or platelet disorder.
- Positive history of major surgery in past 6 months.
- Presence of any acute infection on face like, herpes, folliculitis.
- Patients of HIV, HBsAg, or any chronic illness.
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site
Dhala Medical College
Dhaka
Md. Mohiuddin Sharif, +8801717539682, mohiuddinsharif.fmc@gmail.com
Fahmida Zebin
About this study
Official title: Efficacy and Safety of Ablative Fractional CO2 Laser and Platelet-rich Plasma (PRP) With Microneedling for Treatment of Acne Scars: a Real-world Comparative Study
Road traffic accidents (RTAs) remain a major public health concern worldwide and in Bangladesh, contributing significantly to injury, disability, and premature death. In resource limited settings like Bangladesh, it is crucial to understand the factors that influence survival following an RTA in order to develop effective prevention strategies and improve patient outcomes. Therefore, this study aims to determine the 30 day survival rate and identify predictors of survival among adult RTA victims treated at a tertiary care hospital in Bangladesh. The observational study will be carried out at Emergency and casualty department of Dhaka Medical College Hospital (DMCH) between October 2025 and March 2026. A total of 204 adults (≥18 years) presenting to the hospital's Casualty Department with RTA related injuries will be included. Informed written consent will be obtained from each patient or their legal guardian prior to enrollment. Data will be collected through structured face to face interviews, review of hospital records, and follow up on the 30th day of accident. The follow-up will be conducted either in person or by telephone. Variables will include patient demographics, accident circumstances, admission characteristics, injury pattern and severity, pre-hospital care, clinical condition at admission, hospital management provided, and treatment outcome. All data will be analyzed using SPSS version 25.0. Kaplan-Meier analysis will estimate survival probabilities, while Cox proportional hazards regression will be used to identify independent predictors of mortality. The findings of this study are expected to generate context-specific, evidence-based insights for strengthening trauma care protocols, gap related to emergency handling of the RTA patients, enhancing pre-hospital emergency services, and informing policy decisions aimed at reducing preventable RTA-related mortality and morbidity in Bangladesh.
Read the detailed description
Study Rationale:
Acne scars, notably atrophic scars, pose significant cosmetic and psychological concerns. Standard treatments include fractional lasers and microneedling-based interventions; however, rigorous comparative data in real-world clinical settings remain scarce. Recent evidence suggests ablative fractional CO2 laser and PRP-enhanced microneedling offer notable benefits. This split-face design allows direct comparison of efficacy, safety, and patient satisfaction between the modalities among Bangladeshi patients.
Study Design:
Type: Phase 3, open-label, randomized, split-face, comparative clinical trial
Planned Sample Size: 116 participants
Setting: Department of Dermatology, Dhaka Medical College Hospital, Bangladesh
Duration: April 2025 to March 2026
Randomization: Side of face assigned to either intervention via coin toss
Blinding: Open-label; outcome assessment by independent dermatologist blinded to intervention side
Eligibility Criteria:
Inclusion:
Age >18 years
Both sexes
Grade 2-4 acne scarring (Goodman \& Baron qualitative grading)
Equal baseline scar grades on both facial halves
Atrophic scars only (no active acne)
Exclusion:
History of keloidal tendency
Bleeding or platelet disorders
Major surgery in past 6 months
Active facial infection (e.g., herpes, folliculitis)
HIV, hepatitis B surface antigen (HBsAg), or chronic illness
Pregnancy
Interventions:
Ablative Fractional CO2 Laser:
Pre-treatment: 2.5% lidocaine + 2.5% prilocaine cream (45 minutes), antiseptic cleansing
Device: SmartXide DOT Fractionated CO2 Laser (15 W, 800 μm spacing, 600 µs dwell, stack 2)
Three sessions, one month apart
PRP with Microneedling:
Pre-treatment: 2.5% lidocaine + 2.5% prilocaine cream (2 hours), antiseptic cleansing
PRP Preparation: 8 mL blood with double spin centrifugation to yield 2 mL PRP, platelet count verified
Intradermal PRP injection (nappage technique), followed by dermapen microneedling (1.5 mm depth, 12-needle cartridge, 4-directional passes)
Three sessions, one month apart
Follow-up and Data Collection:
Baseline, day 30, day 60, final (day 90 post first session)
Outcome measures collected via clinical assessments, standardized photographs, patient questionnaires, and independent dermatologist review
Adverse events monitored throughout
Outcome Measures:
Primary:
Change in Goodman \& Baron quantitative and qualitative acne scar grades at 90 days
Secondary:
Independent dermatologist evaluation (10-point VAS, categorized for analysis)
Patient satisfaction (5-point Likert scale)
Frequency and type of adverse events/side effects
Subgroup analyses by scar severity, skin type, and sex
Statistical Analysis:
All analyses by intention-to-treat
Continuous data: Paired t-tests (within-group), independent t-test or Mann-Whitney U (between modalities)
Qualitative grades: McNemar's test (within-group), chi-square (between modalities)
Categorical responses (dermatologist VAS, satisfaction, side effects): chi-square or Fisher exact
95% confidence intervals, significance level 0.05
Safety Monitoring:
Data and Safety Monitoring Board (DSMB) of independent experts
GCP compliance and interim reviews
Adverse event reporting follows national and institutional guidelines
Ethical Considerations:
Written informed consent (Bengali/English)
Withdrawal permitted at any time without detriment to care
Confidential data handling in accordance with local regulations
Institutional ethics committee approval obtained
Keywords:
Acne scars, fractional CO2 laser, platelet-rich plasma, microneedling, randomized trial, Bangladesh, split-face, dermatology, Goodman and Baron, patient satisfaction, safety
- Being tested
- Ablative Fractional CO₂ Laser, Platelet-Rich Plasma (PRP) With Microneedling
- Keywords
- Acne Scars, Ablative fractional CO₂ laser therapy, Platelet-rich plasma (PRP), Microneedling, Efficacy, Safety, Bangladesh, Goodman and Baron scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablative Fractional CO₂ LaserProcedure or surgery
Participants will receive ablative fractional CO₂ laser therapy on one side of the face using the SmartXide DOT Fractionated CO₂ Laser system. Treatment parameters: 15 W power, 800 µm spacing, 600 µs dwell time, stack level 2. Sessions: 3, each one month apart.
Platelet-Rich Plasma (PRP) With MicroneedlingProcedure or surgery
Participants will receive intradermal autologous PRP injections prepared by double-spin centrifugation from 8 mL of venous blood, followed by microneedling with a Dermapen (12-needle cartridge, 1.5 mm depth). Endpoint: pinpoint bleeding. Sessions: 3, each one month apart.
| Study group | Role | What they receive |
|---|---|---|
| Ablative fractional CO2 laser | Active comparator | Participants will receive ablative fractional CO₂ laser therapy on one side of the face using the SmartXide DOT Fractionated CO₂ Laser system. Treatment parameters include 15 W power, 800 µm spacing, 600 µs dwell time, and stack level 2. A total of three sessions will be administered, each one month apart. Receives: Procedure: Ablative Fractional CO₂ Laser |
| Platelet-Rich Plasma (PRP) With Microneedling | Experimental | Participants will receive intradermal injections of autologous PRP followed by microneedling on the opposite side of the face. PRP will be prepared using a double-spin centrifugation method from 8 mL of venous blood. Microneedling will be performed with a Dermapen (12-needle cartridge, 1.5 mm depth) until pinpoint bleeding is observed. A total of three sessions will be administered, each one month apart. Receives: Procedure: Platelet-Rich Plasma (PRP) With Microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Goodman and Baron Acne Scar Grading (Quantitative and Qualitative)
Improvement in acne scars will be assessed using the Goodman and Baron quantitative global acne scarring grading system and qualitative global acne scarring grading system.
Measured: Day 30 (prior to Session 2), Day 60 (prior to Session 3), and at the final follow-up visit on Day 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne 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
- Model description
- This is a randomized, split-face, open-label trial. Each participant will receive ablative fractional CO₂ laser therapy on one side of the face and platelet-rich plasma (PRP) with microneedling on the other side. The split-face design allows within-participant comparison of the two treatment modalities.
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Sirajul Islam Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Dhaka Medical College
- Responsible party
- Principal investigator, Azmiree Binte Aslam, Dr. Sirajul Islam Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189923
- Sponsor's protocol ID
- IRB-DMC/2025/48
- Status last verified
- Dec 2025
- First submitted
- 16 Sep 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, there is no plan to share individual participant data (IPD) from this study. This decision is based on institutional policy, local regulatory considerations, and the need to protect participant confidentiality. De-identified data may be considered for sharing in the future upon appropriate request and with approval from the study's ethical review committee, but no prospective data sharing plan is in place at present.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ablative Fractional CO2 Laser and Platelet-rich Plasma (PRP) With Microneedling for Treatment of Acne Scars: a Real-world Comparative Study
- ClinicalTrials.gov ID
- NCT07189923
- Acronym / sponsor ID
- IRB-DMC/2025/48
- Keywords
- Acne Scars, Ablative fractional CO₂ laser therapy, Platelet-rich plasma (PRP), Microneedling, Efficacy, Safety, Bangladesh, Goodman and Baron scale
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Dr. Sirajul Islam Medical CollegeUniversity, hospital or other
- Collaborators
- Dhaka Medical College
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 24 Sep 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.
Road traffic accidents (RTAs) remain a major public health concern worldwide and in Bangladesh, contributing significantly to injury, disability, and premature death. In resource limited settings like Bangladesh, it is crucial to understand the factors that influence survival following an RTA in order to develop effective prevention strategies and improve patient outcomes. Therefore, this study aims to determine the 30 day survival rate and identify predictors of survival among adult RTA victims treated at a tertiary care hospital in Bangladesh. The observational study will be carried out at Emergency and casualty department of Dhaka Medical College Hospital (DMCH) between October 2025 and March 2026. A total of 204 adults (≥18 years) presenting to the hospital's Casualty Department with RTA related injuries will be included. Informed written consent will be obtained from each patient or their legal guardian prior to enrollment. Data will be collected through structured face to face interviews, review of hospital records, and follow up on the 30th day of accident. The follow-up will be conducted either in person or by telephone. Variables will include patient demographics, accident circumstances, admission characteristics, injury pattern and severity, pre-hospital care, clinical condition at admission, hospital management provided, and treatment outcome. All data will be analyzed using SPSS version 25.0. Kaplan-Meier analysis will estimate survival probabilities, while Cox proportional hazards regression will be used to identify independent predictors of mortality. The findings of this study are expected to generate context-specific, evidence-based insights for strengthening trauma care protocols, gap related to emergency handling of the RTA patients, enhancing pre-hospital emergency services, and informing policy decisions aimed at reducing preventable RTA-related mortality and morbidity in Bangladesh.
Detailed description
Study Rationale:
Acne scars, notably atrophic scars, pose significant cosmetic and psychological concerns. Standard treatments include fractional lasers and microneedling-based interventions; however, rigorous comparative data in real-world clinical settings remain scarce. Recent evidence suggests ablative fractional CO2 laser and PRP-enhanced microneedling offer notable benefits. This split-face design allows direct comparison of efficacy, safety, and patient satisfaction between the modalities among Bangladeshi patients.
Study Design:
Type: Phase 3, open-label, randomized, split-face, comparative clinical trial
Planned Sample Size: 116 participants
Setting: Department of Dermatology, Dhaka Medical College Hospital, Bangladesh
Duration: April 2025 to March 2026
Randomization: Side of face assigned to either intervention via coin toss
Blinding: Open-label; outcome assessment by independent dermatologist blinded to intervention side
Eligibility Criteria:
Inclusion:
Age >18 years
Both sexes
Grade 2-4 acne scarring (Goodman \& Baron qualitative grading)
Equal baseline scar grades on both facial halves
Atrophic scars only (no active acne)
Exclusion:
History of keloidal tendency
Bleeding or platelet disorders
Major surgery in past 6 months
Active facial infection (e.g., herpes, folliculitis)
HIV, hepatitis B surface antigen (HBsAg), or chronic illness
Pregnancy
Interventions:
Ablative Fractional CO2 Laser:
Pre-treatment: 2.5% lidocaine + 2.5% prilocaine cream (45 minutes), antiseptic cleansing
Device: SmartXide DOT Fractionated CO2 Laser (15 W, 800 μm spacing, 600 µs dwell, stack 2)
Three sessions, one month apart
PRP with Microneedling:
Pre-treatment: 2.5% lidocaine + 2.5% prilocaine cream (2 hours), antiseptic cleansing
PRP Preparation: 8 mL blood with double spin centrifugation to yield 2 mL PRP, platelet count verified
Intradermal PRP injection (nappage technique), followed by dermapen microneedling (1.5 mm depth, 12-needle cartridge, 4-directional passes)
Three sessions, one month apart
Follow-up and Data Collection:
Baseline, day 30, day 60, final (day 90 post first session)
Outcome measures collected via clinical assessments, standardized photographs, patient questionnaires, and independent dermatologist review
Adverse events monitored throughout
Outcome Measures:
Primary:
Change in Goodman \& Baron quantitative and qualitative acne scar grades at 90 days
Secondary:
Independent dermatologist evaluation (10-point VAS, categorized for analysis)
Patient satisfaction (5-point Likert scale)
Frequency and type of adverse events/side effects
Subgroup analyses by scar severity, skin type, and sex
Statistical Analysis:
All analyses by intention-to-treat
Continuous data: Paired t-tests (within-group), independent t-test or Mann-Whitney U (between modalities)
Qualitative grades: McNemar's test (within-group), chi-square (between modalities)
Categorical responses (dermatologist VAS, satisfaction, side effects): chi-square or Fisher exact
95% confidence intervals, significance level 0.05
Safety Monitoring:
Data and Safety Monitoring Board (DSMB) of independent experts
GCP compliance and interim reviews
Adverse event reporting follows national and institutional guidelines
Ethical Considerations:
Written informed consent (Bengali/English)
Withdrawal permitted at any time without detriment to care
Confidential data handling in accordance with local regulations
Institutional ethics committee approval obtained
Keywords:
Acne scars, fractional CO2 laser, platelet-rich plasma, microneedling, randomized trial, Bangladesh, split-face, dermatology, Goodman and Baron, patient satisfaction, safety
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, split-face, open-label trial. Each participant will receive ablative fractional CO₂ laser therapy on one side of the face and platelet-rich plasma (PRP) with microneedling on the other side. The split-face design allows within-participant comparison of the two treatment modalities.
| Arm | Type | Receives |
|---|---|---|
| Ablative fractional CO2 laser | Active comparator | Procedure: Ablative Fractional CO₂ LaserParticipants will receive ablative fractional CO₂ laser therapy on one side of the face using the SmartXide DOT Fractionated CO₂ Laser system. Treatment parameters include 15 W power, 800 µm spacing, 600 µs dwell time, and stack level 2. A total of three sessions will be administered, each one month apart. |
| Platelet-Rich Plasma (PRP) With Microneedling | Experimental | Procedure: Platelet-Rich Plasma (PRP) With MicroneedlingParticipants will receive intradermal injections of autologous PRP followed by microneedling on the opposite side of the face. PRP will be prepared using a double-spin centrifugation method from 8 mL of venous blood. Microneedling will be performed with a Dermapen (12-needle cartridge, 1.5 mm depth) until pinpoint bleeding is observed. A total of three sessions will be administered, each one month apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients (age >18 years)
- Both male and female sex
- Patients with grade 2 to grade 4 acne scars, classified on the basis of Goodman's Qualitative classification.
- Patient with equal Goodman's Qualitative scores on both halves of the face.
- No active acne lesions.
Key exclusion criteria (6 listed)
- Positive history of keloidal tendency.
- Positive history of bleeding or platelet disorder.
- Positive history of major surgery in past 6 months.
- Presence of any acute infection on face like, herpes, folliculitis.
- Patients of HIV, HBsAg, or any chronic illness.
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 |
|---|---|---|
| Ablative Fractional CO₂ LaserParticipants will receive ablative fractional CO₂ laser therapy on one side of the face using the SmartXide DOT Fractionated CO₂ Laser system. Treatment parameters: 15 W power, 800 µm spacing, 600 µs dwell time, stack level 2. Sessions: 3, each one month apart. | Procedure or surgery | Ablative fractional CO2 laser |
| Platelet-Rich Plasma (PRP) With MicroneedlingParticipants will receive intradermal autologous PRP injections prepared by double-spin centrifugation from 8 mL of venous blood, followed by microneedling with a Dermapen (12-needle cartridge, 1.5 mm depth). Endpoint: pinpoint bleeding. Sessions: 3, each one month apart. | Procedure or surgery | Platelet-Rich Plasma (PRP) With Microneedling |
Primary outcome
Change in Goodman and Baron Acne Scar Grading (Quantitative and Qualitative)
Time frame: Day 30 (prior to Session 2), Day 60 (prior to Session 3), and at the final follow-up visit on Day 150
Improvement in acne scars will be assessed using the Goodman and Baron quantitative global acne scarring grading system and qualitative global acne scarring grading system.
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 3 Dec 2025.
- Individual participant dataSharing planned: No. At this time, there is no plan to share individual participant data (IPD) from this study. This decision is based on institutional policy, local regulatory considerations, and the need to protect participant confidentiality. De-identified data may be considered for sharing in the future upon appropriate request and with approval from the study's ethical review committee, but no prospective data sharing plan is in place at present.
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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 study testing Ablative Fractional CO₂ Laser and Platelet-Rich Plasma (PRP) With Microneedling in people with Acne Scars and Ablative Fractional CO₂ Laser Therapy, run by Dr. Sirajul Islam Medical College at 1 site in Bangladesh.
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 6 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: opening soon, as of the sponsor's last update on 3 Dec 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 Bangladesh. 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?
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 Mohammad Jahid Hasan, MBBS, MPH (+8801767818973, dr.jahid61@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Goodman and Baron Acne Scar Grading (Quantitative and Qualitative) (time frame: Day 30 (prior to Session 2), Day 60 (prior to Session 3), and at the final follow-up visit on Day 150). 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 3 Dec 2025.