Clinical trial NCT04252352: Treatment of Acne Scars With Fractional CO2 Laser Versus Radio-frequency Microneedling
Official title: Treatment of Acne Scars With Fractional CO2 Laser Versus Radio-frequency Microneedling: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acne Scars - Mixed Atrophic and Hypertrophic
Keywords: Fractional CO2 laser
Radio-frequency microneedling
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
First posted: 2020-02-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intra-person split-face trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Asymmetry (scar texture, erythema, pigmentation)
timeFrame: 3 months
measure: Patient satisfaction
timeFrame: 3 months
measure: Adverse effects ( wounds, scars, pigmentation, erythema, edema)
timeFrame: 3 months
measure: Optical coherence tomography
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen NV
Study officials:
affiliation: Bispebjerg Hospital
name: June Svendsen, Nurse
role: STUDY_DIRECTOR
References: