Treatment of Acne Scars With Fractional CO2 Laser Versus Radio-frequency Microneedling
Primary Purpose
Acne Scars - Mixed Atrophic and Hypertrophic
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling
Sponsored by
About this trial
This is an interventional treatment trial for Acne Scars - Mixed Atrophic and Hypertrophic focused on measuring Fractional CO2 laser, Radio-frequency microneedling
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
Sites / Locations
- Bispebjerg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ablative fractional CO2 laser resurfacing
Radio-frequency microneedling
Arm Description
One fractional CO2 laser treatment are performed of acne scars on one side of the face
One radio-frequency microneedling treatment are performed of acne scars on one side of the face
Outcomes
Primary Outcome Measures
Asymmetry (scar texture, erythema, pigmentation)
Patient satisfaction
Adverse effects ( wounds, scars, pigmentation, erythema, edema)
Optical coherence tomography
Secondary Outcome Measures
Full Information
NCT ID
NCT04252352
First Posted
January 21, 2020
Last Updated
January 31, 2020
Sponsor
Aarhus University Hospital
Collaborators
Bispebjerg Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04252352
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2020 (Anticipated)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aarhus University Hospital
Collaborators
Bispebjerg Hospital
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars - Mixed Atrophic and Hypertrophic
Keywords
Fractional CO2 laser, Radio-frequency microneedling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intra-person split-face trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ablative fractional CO2 laser resurfacing
Arm Type
Active Comparator
Arm Description
One fractional CO2 laser treatment are performed of acne scars on one side of the face
Arm Title
Radio-frequency microneedling
Arm Type
Active Comparator
Arm Description
One radio-frequency microneedling treatment are performed of acne scars on one side of the face
Intervention Type
Device
Intervention Name(s)
Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling
Other Intervention Name(s)
Fractional CO2 laser (Lumenis UltraPuls Encore laser system, Yokneam, Israel)/Radio-frequency microneedling device (LUTRONIC INFINI/ GENIUS, Goyang, Korea)
Intervention Description
Intra-person split-face trial
Primary Outcome Measure Information:
Title
Asymmetry (scar texture, erythema, pigmentation)
Time Frame
3 months
Title
Patient satisfaction
Time Frame
3 months
Title
Adverse effects ( wounds, scars, pigmentation, erythema, edema)
Time Frame
3 months
Title
Optical coherence tomography
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merete Hædersdal, MD,PhD,DMSc
Phone
+4520416746
Email
merete.haedersdal@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
June Svendsen, Nurse
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
State/Province
Copenhagen NV
ZIP/Postal Code
2400
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merete Hædersdal, MD, PhD,DMSc
Phone
+4520416746
Email
merete.haedersdal@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Acne Scars With Fractional CO2 Laser Versus Radio-frequency Microneedling
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