Safety and Efficacy of the 4MD Micro Needling Device in the Treatment of Acne Scars

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

Study Overview

• Status: Completed
• Conditions: Acne Scarring
• Intervention / Treatment: Device: Micro needling

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 Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• Spain
  • Marbella, Spain, 29601
    • Dr Gabriela Casabona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy male & females; 18 to 65 years of age with signs of post-acne facial atrophic scarring.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks after last treatment versus baseline (first treatment).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time in which redness, pain, and discomfort after treatment decreases.	The time in which redness, pain, and discomfort after treatment decreases.	4 weeks

Collaborators and Investigators

• Sponsor: Dermapenworld

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 19, 2020
• Primary Completion (ACTUAL): October 9, 2020
• Study Completion (ACTUAL): October 9, 2020

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (ACTUAL): May 23, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: Derma_01 1482-N-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data forms part of 510K submission and is confidential

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No