NCT04252352

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

January 21, 2020

Last Update Submit

January 31, 2020

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Keywords

Fractional CO2 laserRadio-frequency microneedling

Outcome Measures

Primary Outcomes (4)

  • Asymmetry (scar texture, erythema, pigmentation)

    3 months

  • Patient satisfaction

    3 months

  • Adverse effects ( wounds, scars, pigmentation, erythema, edema)

    3 months

  • Optical coherence tomography

    3 months

Study Arms (2)

Ablative fractional CO2 laser resurfacing

ACTIVE COMPARATOR

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

Device: Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling

Radio-frequency microneedling

ACTIVE COMPARATOR

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

Device: Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling

Interventions

Ablative fractional CO2 laser resurfacing/Radio-frequency microneedlingDEVICE

Intra-person split-face trial

Also known as: Fractional CO2 laser (Lumenis UltraPuls Encore laser system, Yokneam, Israel)/Radio-frequency microneedling device (LUTRONIC INFINI/ GENIUS, Goyang, Korea)
Ablative fractional CO2 laser resurfacingRadio-frequency microneedling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Copenhagen NV, 2400, Denmark

Location

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • June Svendsen, Nurse

    Bispebjerg Hospital

    STUDY DIRECTOR

Central Study Contacts

Merete Hædersdal, MD,PhD,DMSc

CONTACT

+4520416746merete.haedersdal@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intra-person split-face trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2020

First Posted

February 5, 2020

Study Start

February 1, 2020

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

February 5, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)