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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04252352
• Other study ID #: CO2 laser vs radio-frequency
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2020
• Est. completion date: October 2020

Study information

• Verified date: January 2020
• Source: University of Aarhus
• Contact: Merete Hædersdal, MD,PhD,DMSc
• Phone: +4520416746
• Email: merete.haedersdal[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Scars - Mixed Atrophic and Hypertrophic
• Hypertrophy

Intervention

Device:
• Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling
Intra-person split-face trial

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	Copenhagen NV

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asymmetry (scar texture, erythema, pigmentation)		3 months
Primary	Patient satisfaction		3 months
Primary	Adverse effects ( wounds, scars, pigmentation, erythema, edema)		3 months
Primary	Optical coherence tomography		3 months