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

Acne Scarring Clinical Trial

Official title: Safety and Efficacy of the 4MD Microneedling Device in the Treatment of Acne Scars

Status Completed

Clinical 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 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acne Scarring
• Cicatrix

• NCT number: NCT05386732
• Study type: Observational
• Source: Dermapenworld
• Status: Completed
• Start date: June 19, 2020
• Completion date: October 9, 2020