NCT07189923

Comparative Real-world Study on Ablative Fractional CO₂ Laser vs PRP With Microneedling for Acne Scar Treatment.

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Dr. Sirajul Islam Medical College · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Acne Scars
• Ablative Fractional CO₂ Laser Therapy
• Platelet-rich Plasma (PRP)

Interventions

Type	Name	Description
PROCEDURE	Ablative Fractional CO₂ Laser	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.
PROCEDURE	Platelet-Rich Plasma (PRP) With Microneedling	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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-09-30
• Completion: 2026-11-30
• First posted: 2025-09-24
• Last updated: 2025-12-03

Locations

1 site across 1 country: Bangladesh