Acne ScarringNCT05386732
Safety and Efficacy of the 4MD Micro Needling Device in the Treatment of Acne Scars
An observational study of Acne Scarring, run by Dermapenworld at 1 site in Spain.
Trial summary
The objective of this post market clinical follow-up study is to assess the safety and effectiveness of the 4MD microneedling device in reducing scarring of atrophic acne scars. The Primary endpoint was to show a reduction in acne scarring in accordance with the Acne Scar Assessment Scale as used by Skinpen (Bellus… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Scarring
- What is being tested?
- Micro needling
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 19 Jun 2020to 9 Oct 2020
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy male \& females; 18 to 65 years of age with signs of post-acne facial atrophic scarring.
Who may be able to join
- Healthy male \& females; 18 to 65 years of age with signs of post-acne facial atrophic scarring.
- Voluntary participation
- Ability to comprehend and provide informed consent.
- Participants agree NOT to use any topical agents containing active ingredients such as retinol, glycolic acid or products that will induce skin peeling or change the appearance of acne scars in the treatment area, during the study period.
- Participants agree NOT to undergo any aesthetic treatments that influence appearing of acne scarring (such as Botox, fillers, microdermabrasion, laser surfacing, chemical peels etc.) in the treatment area, during the study period.
- Participants agree NOT to take part in another clinical study or undergo other treatments during the study period.
Who cannot join
- Haemophilia / bleeding disorder
- Uncontrolled diabetes mellitus
- Treatment of eyeball or mucosa
- Treatment of skin area with dermatosis, e.g. skin tumor, keloid (or extreme keloidal tendency), solar keratosis, warts, or birth marks
- Anticoagulant therapy, e.g. warfarin, heparin, salicylic acid
- Chemotherapy, radiotherapy, or high doses of corticosteroids
Show all 14Show fewer
- Systemic infection (e.g. hepatitis) or acute skin infection (e.g. herpes)
- Any form of active acne
- Allergic reaction to topical and local anesthetics
- Pregnancy and lactation
- Eczema, exanthema or open wounds
- Scars not older than 6 months
- Skin area with plastic surgery in the past 12 months
- Skin area with filler or Botox injections in the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of the 4MD Microneedling Device in the Treatment of Acne Scars
The objective of this post market clinical follow-up study is to assess the safety and effectiveness of the 4MD microneedling device in reducing scarring of atrophic acne scars.
The Primary endpoint was to show a reduction in acne scarring in accordance with the Acne Scar Assessment Scale as used by Skinpen (Bellus Medical (DEN160029)).
Goodman and Baron and Jacob acne scar assessment and classification will also be utilized Safety endpoint: incidence of adverse events and side effects
Read the detailed description
This is a post market study involving 22 healthy patients. Screening data was reviewed to determine eligibility. After informed consent, confidentiality and photographic release forms, participants who meet all inclusion criteria and none of the exclusion criteria were entered into the study. Each patient underwent 2 micro needling sessions 4 weeks apart using the 4MD microneedling device and individual sterile microneedling cartridge (16, 3mm, 33-gauge surgical grade stainless steel needles, arranged in a circular pattern) Patients were assessed at baseline and at week 8. If the assessing physician deemed a 3rd treatment was necessary, the patient underwent the third treatment and would be assessed 4 weeks after the 3rd microneedling treatment Routine VECTRA photography was taken at Baseline, and at the final assessment (4 weeks after what was deemed the last treatment).
Patients' VECTRA photography was used to assess acne scarring at baseline and 4 weeks after the last treatment using the Acne Scar Assessment Scale (DEN160029) by Karnick et al. Assessment was carried out by the principle investigator and 2 blinded physicians.
After each treatment, patients completed a treatment experience assessment and patient diaries including self-assessment of side effects from the day of the treatment to day 7.
The number, type, and severity of adverse events were recorded during the duration of the study period.
- Conditions
- Acne Scarring
- Being tested
- Micro needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro needlingDevice
All patients were treated with a 16 needle, 3mm, 33-gauge surgical grade stainless steel needle cartridge. The operator began treatment using a depth of (1mm) and a frequency setting of 4 (corresponding to 120 Hz). Needle depth and frequency was adjusted until pin-point bleeding occured, the minimum and maximum depth used to create pinpoint bleeding was recorded. The operator began treatment using a minimum depth of 1mm and a frequency setting of 4 (corresponding to 120 Hz). Needle depth and frequency was adjusted until pin-point bleeding occurred.
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate a reduction in acne scarring in accordance with the Acne Scar Assessment Scale (DEN160029) 4 weeks after last treatment versus baseline (first treatment).
Demonstrate a reduction in acne scarring in accordance with the Acne Scar Assessment Scale (DEN160029) 4 weeks after last treatment versus baseline (first treatment).
Scale is a 5 point scale where 0 is no acne scarring and 5 is all or almost all acne scars can be seen with direct lighting.
Measured: 4 weeks after last treatment versus baseline (first treatment).
Secondary outcomes (1)
The time in which redness, pain, and discomfort after treatment decreases.
The time in which redness, pain, and discomfort after treatment decreases.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start19 Jun 2020
- Primary completion9 Oct 2020
- Study completion9 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne ScarringStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermapenworld
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386732
- Sponsor's protocol ID
- Derma_01 1482-N-20
- Status last verified
- May 2022
- First submitted
- 18 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data forms part of 510K submission and is confidential
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the 4MD Microneedling Device in the Treatment of Acne Scars
- ClinicalTrials.gov ID
- NCT05386732
- Acronym / sponsor ID
- Derma_01 1482-N-20
- Conditions
- Acne Scarring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- DermapenworldIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 9 Oct 2020 (actual)
- Study completion
- 9 Oct 2020 (actual)
- First posted
- 23 May 2022 (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 objective of this post market clinical follow-up study is to assess the safety and effectiveness of the 4MD microneedling device in reducing scarring of atrophic acne scars.
The Primary endpoint was to show a reduction in acne scarring in accordance with the Acne Scar Assessment Scale as used by Skinpen (Bellus Medical (DEN160029)).
Goodman and Baron and Jacob acne scar assessment and classification will also be utilized Safety endpoint: incidence of adverse events and side effects
Detailed description
This is a post market study involving 22 healthy patients. Screening data was reviewed to determine eligibility. After informed consent, confidentiality and photographic release forms, participants who meet all inclusion criteria and none of the exclusion criteria were entered into the study. Each patient underwent 2 micro needling sessions 4 weeks apart using the 4MD microneedling device and individual sterile microneedling cartridge (16, 3mm, 33-gauge surgical grade stainless steel needles, arranged in a circular pattern) Patients were assessed at baseline and at week 8. If the assessing physician deemed a 3rd treatment was necessary, the patient underwent the third treatment and would be assessed 4 weeks after the 3rd microneedling treatment Routine VECTRA photography was taken at Baseline, and at the final assessment (4 weeks after what was deemed the last treatment).
Patients' VECTRA photography was used to assess acne scarring at baseline and 4 weeks after the last treatment using the Acne Scar Assessment Scale (DEN160029) by Karnick et al. Assessment was carried out by the principle investigator and 2 blinded physicians.
After each treatment, patients completed a treatment experience assessment and patient diaries including self-assessment of side effects from the day of the treatment to day 7.
The number, type, and severity of adverse events were recorded during the duration of the study period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy male \& females; 18 to 65 years of age with signs of post-acne facial atrophic scarring.
Key inclusion criteria (6 listed)
- Healthy male \& females; 18 to 65 years of age with signs of post-acne facial atrophic scarring.
- Voluntary participation
- Ability to comprehend and provide informed consent.
- Participants agree NOT to use any topical agents containing active ingredients such as retinol, glycolic acid or products that will induce skin peeling or change the appearance of acne scars in the treatment area, during the study period.
- Participants agree NOT to undergo any aesthetic treatments that influence appearing of acne scarring (such as Botox, fillers, microdermabrasion, laser surfacing, chemical peels etc.) in the treatment area, during the study period.
Key exclusion criteria (14 listed)
- Haemophilia / bleeding disorder
- Uncontrolled diabetes mellitus
- Treatment of eyeball or mucosa
- Treatment of skin area with dermatosis, e.g. skin tumor, keloid (or extreme keloidal tendency), solar keratosis, warts, or birth marks
- Anticoagulant therapy, e.g. warfarin, heparin, salicylic acid
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 |
|---|---|---|
| Micro needlingAll patients were treated with a 16 needle, 3mm, 33-gauge surgical grade stainless steel needle cartridge. The operator began treatment using a depth of (1mm) and a frequency setting of 4 (corresponding to 120 Hz). Needle depth and frequency was adjusted until pin-point bleeding occured, the minimum and maximum depth used to create pinpoint bleeding was recorded. The operator began treatment using a minimum depth of 1mm and a frequency setting of 4 (corresponding to 120 Hz). Needle depth and frequency was adjusted until pin-point bleeding occurred. | Device | – |
Primary outcome
Demonstrate a reduction in acne scarring in accordance with the Acne Scar Assessment Scale (DEN160029) 4 weeks after last treatment versus baseline (first treatment).
Time frame: 4 weeks after last treatment versus baseline (first treatment).
Demonstrate a reduction in acne scarring in accordance with the Acne Scar Assessment Scale (DEN160029) 4 weeks after last treatment versus baseline (first treatment). Scale is a 5 point scale where 0 is no acne scarring and 5 is all or almost all acne scars can be seen with direct lighting.
1 secondary outcome
The time in which redness, pain, and discomfort after treatment decreases.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: No. Data forms part of 510K submission and is confidential
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Scarring, run by Dermapenworld at 1 site in Spain.
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 27 May 2022. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate a reduction in acne scarring in accordance with the Acne Scar Assessment Scale (DEN160029) 4 weeks after last treatment versus baseline (first treatment). (time frame: 4 weeks after last treatment versus baseline (first treatment).). 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 27 May 2022.