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

NCT ID: NCT04252352

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-29

Study Completion Date

2020-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acne Scars - Mixed Atrophic and Hypertrophic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intra-person split-face trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ablative fractional CO2 laser resurfacing

One fractional CO2 laser treatment are performed of acne scars on one side of the face

Group Type ACTIVE_COMPARATOR

Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling

Intervention Type DEVICE

Intra-person split-face trial

Radio-frequency microneedling

One radio-frequency microneedling treatment are performed of acne scars on one side of the face

Group Type ACTIVE_COMPARATOR

Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling

Intervention Type DEVICE

Intra-person split-face trial

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling

Intra-person split-face trial

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fractional CO2 laser (Lumenis UltraPuls Encore laser system, Yokneam, Israel)/Radio-frequency microneedling device (LUTRONIC INFINI/ GENIUS, Goyang, Korea)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bispebjerg Hospital

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

June Svendsen, Nurse

Role: STUDY_DIRECTOR

Bispebjerg Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bispebjerg Hospital

Copenhagen, Copenhagen NV, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Merete Hædersdal, MD,PhD,DMSc

Role: CONTACT

+4520416746

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Merete Hædersdal, MD, PhD,DMSc

Role: primary

+4520416746

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CO2 laser vs radio-frequency

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.