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

Not Applicable

• Conditions: Acne Scars - Mixed Atrophic and Hypertrophic

• Registration Number: NCT04252352
• Lead Sponsor: Aarhus University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-01-31
• Last Update Submitted: 2020-01-31
• Study Start: 2020-02
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05
• Primary Completion: 2020-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Copenhagen NV, Denmark