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

Aarhus University Hospital

Status: Unknown

Conditions: Acne Scars - Mixed Atrophic and Hypertrophic

Treatments: Device: Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling

Study type: Interventional

Funder types: Other

Identifiers

NCT04252352

CO2 laser vs radio-frequency

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

15 participants in 2 patient groups

Ablative fractional CO2 laser resurfacing

Active Comparator group

Description:

One fractional CO2 laser treatment are performed of acne scars on one side of the face

Treatment:

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

Radio-frequency microneedling

Active Comparator group

Description:

One radio-frequency microneedling treatment are performed of acne scars on one side of the face

Treatment:

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