Acne Scars - Mixed Atrophic and HypertrophicNCT04252352
Treatment of Acne Scars With Fractional CO2 Laser Versus Radio-frequency Microneedling
A study testing Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling in people with Acne Scars - Mixed Atrophic and Hypertrophic, run by Aarhus University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Scars - Mixed Atrophic and Hypertrophic
- What is being tested?
- Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2020to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg Hospital
Copenhagen, Copenhagen NV, 2400
Merete Hædersdal, MD, PhD,DMSc, +4520416746, merete.haedersdal@regionh.dk
About this study
Official title: Treatment of Acne Scars With Fractional CO2 Laser Versus Radio-frequency Microneedling: A Randomized Controlled Trial
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.
Read more
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.
- Being tested
- Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling
- Keywords
- Fractional CO2 laser, Radio-frequency microneedling
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablative fractional CO2 laser resurfacing/Radio-frequency microneedlingDevice
Also called Fractional CO2 laser (Lumenis UltraPuls Encore laser system, Yokneam, Israel)/Radio-frequency microneedling device (LUTRONIC INFINI/ GENIUS, Goyang, Korea)
Intra-person split-face trial
| Study group | Role | What they receive |
|---|---|---|
| Ablative fractional CO2 laser resurfacing | Active comparator | One fractional CO2 laser treatment are performed of acne scars on one side of the face Receives: 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 Receives: Device: Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asymmetry (scar texture, erythema, pigmentation)
Measured: 3 months
Patient satisfaction
Measured: 3 months
Adverse effects ( wounds, scars, pigmentation, erythema, edema)
Measured: 3 months
Optical coherence tomography
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study startFeb 2020 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne Scars - Mixed Atrophic and HypertrophicStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intra-person split-face trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Sponsor
- Investigators
- June Svendsen, Nurse, Study director, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252352
- Sponsor's protocol ID
- CO2 laser vs radio-frequency
- Status last verified
- Jan 2020
- First submitted
- 21 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acne Scars With Fractional CO2 Laser Versus Radio-frequency Microneedling: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04252352
- Acronym / sponsor ID
- CO2 laser vs radio-frequency
- Keywords
- Fractional CO2 laser, Radio-frequency microneedling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital
- Study start
- Feb 2020 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intra-person split-face trial
| Arm | Type | Receives |
|---|---|---|
| Ablative fractional CO2 laser resurfacing | Active comparator | Device: Ablative fractional CO2 laser resurfacing/Radio-frequency microneedlingOne fractional CO2 laser treatment are performed of acne scars on one side of the face |
| Radio-frequency microneedling | Active comparator | Device: Ablative fractional CO2 laser resurfacing/Radio-frequency microneedlingOne radio-frequency microneedling treatment are performed of acne scars on one side of the face |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablative fractional CO2 laser resurfacing/Radio-frequency microneedlingAlso: Fractional CO2 laser (Lumenis UltraPuls Encore laser system, Yokneam, Israel)/Radio-frequency microneedling device (LUTRONIC INFINI/ GENIUS, Goyang, Korea)Intra-person split-face trial | Device | Ablative fractional CO2 laser resurfacing, Radio-frequency microneedling |
Primary outcome
Asymmetry (scar texture, erythema, pigmentation)
Time frame: 3 months
Patient satisfaction
Time frame: 3 months
Adverse effects ( wounds, scars, pigmentation, erythema, edema)
Time frame: 3 months
Optical coherence tomography
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Acne Scars - Mixed Atrophic and Hypertrophic
Recruiting
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation
Recruiting
AVAVA MIRIA General Use
Acne, Acne Scars - Mixed Atrophic and Hypertrophic
Active, not recruiting
Comparative Effects Of Trichloroacetic Chemical Peel And Fractional Laser
Melasma, Acne Scars - Mixed Atrophic and Hypertrophic
Active, not recruiting
The MIRIA Acne Scar Study
Acne Scars - Mixed Atrophic and Hypertrophic
Active, not recruiting
AV-23-001 AVAVA MIRIA Pilot Study
Wrinkle, Acne Scars - Mixed Atrophic and Hypertrophic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
June Svendsen, Nurse study director
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling in people with Acne Scars - Mixed Atrophic and Hypertrophic, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merete Hædersdal, MD,PhD,DMSc (+4520416746, merete.haedersdal@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asymmetry (scar texture, erythema, pigmentation) (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.