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

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

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.

Study Overview

• Status: Unknown
• Conditions: Acne Scars - Mixed Atrophic and Hypertrophic
• Intervention / Treatment: Device: Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen NV
    • Copenhagen, Copenhagen NV, Denmark, 2400
      • Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ablative fractional CO2 laser resurfacing; 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; Intra-person split-face trial; 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; 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; Intra-person split-face trial; 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?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Bispebjerg Hospital
• Investigators: Study Director: June Svendsen, Nurse, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 31, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Fractional CO2 laser; Radio-frequency microneedling
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: CO2 laser vs radio-frequency

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No