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

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

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