Acne Scars - Mixed Atrophic and Hypertrophic Clinical Trial
Official title:
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.
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