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

NCT ID: NCT07189923

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-11-30

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.

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 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.

Group Type: ACTIVE_COMPARATOR

Ablative Fractional CO₂ Laser

Intervention Type: 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.

Platelet-Rich Plasma (PRP) With Microneedling

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.

Group Type: EXPERIMENTAL

Platelet-Rich Plasma (PRP) With Microneedling

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dhaka Medical College

OTHER

Sponsor Role: collaborator

Dr. Sirajul Islam Medical College

OTHER

Sponsor Role: lead

Responsible Party

Azmiree Binte Aslam

Assistant Professor, Department of Dermatology and Venereology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dhala Medical College

Dhaka, , Bangladesh

Countries

Bangladesh

Central Contacts

Mohammad Jahid Hasan, MBBS, MPH

Role: CONTACT

dr.jahid61@gmail.com

+8801767818973

Tamanna Tabassum, MBBS, MPH

Role: CONTACT

dr.tabassum1991@gmail.com

+8801755383138

Facility Contacts

Md. Mohiuddin Sharif

Role: primary

mohiuddinsharif.fmc@gmail.com

+8801717539682

Other Identifiers

IRB-DMC/2025/48

Identifier Type: -

Identifier Source: org_study_id