Treatment of Acne Scars With Fractional CO2 Laser Versus Radio-frequency Microneedling

Study Overview
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Brief Summary
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The study is a prospective, randomized, controlled, intra-person split-face trial with blinded evaluations. The objective is to compare efficacy and adverse effects of ablative fractional CO2 laser resurfacing versus radio-frequency microneedling for treatment of atrophic acne scars in the facial area. Two comparable areas with acne scars on each side of the face are treated. One area will be treated with fractional CO2 laser and the other area with radio-frequency microneedling. Outcome measures will be assessed by blinded investigators and included subjects at baseline before treatment and at follow-up visits 2-4 days and 1 and 3 months post-treatment. On-site assessment and OCT will be performed at the time of the visits. OCT scans will be offered to the subjects and are optional. Clinical photos are used for documentation. 15 participants will be recruited. The participants will be recruited to enter the trial in the clinic by investigators at the Department of Dermatology, Bispebjerg Hospital, and must meet the inclusion criteria (at least 18 years of age, acne scars in the facial area, comparable atrophic acne scars on each side of the face, fitzpatrick skintype I-III) to be eligible to enter the study. No personal remuneration will be awarded the investigators. None of the collaborators have any personal economic interest in the study. Participants will not receive remuneration. All treatments are performed at the Department of Bispebjerg Hospital and patients are covered by the Hospital's patient insurance. The declaration of Helsinki will be respected as well as the standards of good clinical research. Respect for privacy as well as physically and mentally integrity of the participants will be maintained. The study will be performed in accordance with Danish Health care authorities.

Official Title
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Treatment of Acne Scars With Fractional CO2 Laser Versus Radio-frequency Microneedling: A Randomized Controlled Trial

Conditions
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Acne Scars - Mixed Atrophic and Hypertrophic

Intervention / Treatment
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* Device: Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Acne scars in the facial area (predominantly rolling scars) Comparable atrophic acne scars on each side of the face Fitzpatrick skintype I-III Exclusion Criteria: Pregnant or nursing women Treatment with isotretinoin within the last 6 months Current treatment with NSAID and prednisolone Known tendencies to produce hypertrophic scars or keloids Infection in the treatment area Considered unable to follow the study protocol, e.g. alcohol dependence syndrome

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intra-person split-face trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ablative fractional CO2 laser resurfacing<br>One fractional CO2 laser treatment are performed of acne scars on one side of the face | Device: Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling<br>* Intra-person split-face trial<br>* Other names: Fractional CO2 laser (Lumenis UltraPuls Encore laser system, Yokneam, Israel)/Radio-frequency microneedling device (LUTRONIC INFINI/ GENIUS, Goyang, Korea);|
| Active Comparator: Radio-frequency microneedling<br>One radio-frequency microneedling treatment are performed of acne scars on one side of the face | Device: Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling<br>* Intra-person split-face trial<br>* Other names: Fractional CO2 laser (Lumenis UltraPuls Encore laser system, Yokneam, Israel)/Radio-frequency microneedling device (LUTRONIC INFINI/ GENIUS, Goyang, Korea);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asymmetry (scar texture, erythema, pigmentation) |  | 3 months | 
| Patient satisfaction |  | 3 months | 
| Adverse effects ( wounds, scars, pigmentation, erythema, edema) |  | 3 months | 
| Optical coherence tomography |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fractional CO2 laser, Radio-frequency microneedling