Treatment of Acne Scars With Fractional CO2 Laser Versus Radio-frequency Microneedling
NCT ID: NCT04252352
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
15 participants
INTERVENTIONAL
2020-02-29
2020-10-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ablative fractional CO2 laser resurfacing
One fractional CO2 laser treatment are performed of acne scars on one side of the face
Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling
Intra-person split-face trial
Radio-frequency microneedling
One radio-frequency microneedling treatment are performed of acne scars on one side of the face
Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling
Intra-person split-face trial
Interventions
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Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling
Intra-person split-face trial
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Bispebjerg Hospital
OTHER
Aarhus University Hospital
OTHER
Responsible Party
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Principal Investigators
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June Svendsen, Nurse
Role: STUDY_DIRECTOR
Bispebjerg Hospital
Locations
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Bispebjerg Hospital
Copenhagen, Copenhagen NV, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CO2 laser vs radio-frequency
Identifier Type: -
Identifier Source: org_study_id
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