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

NCT07189923 | Not Yet Recruiting DMC

• 1 other identifier: IRB-DMC/2025/48
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Acne Scars; Ablative fractional CO₂ laser therapy; Platelet-rich plasma (PRP); Microneedling; Efficacy; Safety; Bangladesh; Goodman and Baron scale

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 30 (prior to Session 2), Day 60 (prior to Session 3), and at the final follow-up visit on Day 150

Study Arms (2)

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.

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.

Procedure: Platelet-Rich Plasma (PRP) With Microneedling

Interventions

Ablative Fractional CO₂ Laser PROCEDURE

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.

Ablative fractional CO2 laser

Platelet-Rich Plasma (PRP) With Microneedling PROCEDURE

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.

Platelet-Rich Plasma (PRP) With Microneedling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Sirajul Islam Medical College: lead
• Dhaka Medical College: collaborator

Study Sites (1)

Dhala Medical College

Dhaka, Bangladesh

Location

Central Study Contacts

Mohammad Jahid Hasan, MBBS, MPH

CONTACT

+8801767818973; dr.jahid61@gmail.com

Tamanna Tabassum, MBBS, MPH

CONTACT

+8801755383138; dr.tabassum1991@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Dermatology and Venereology

Model Details: 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.

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)