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

NCT05386732 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2022-05-27

No results posted yet for this study

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

Conditions

  • Acne Scarring

Interventions

DEVICE

Micro needling

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.

Sponsors & Collaborators

  • Dermapenworld

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-19
Primary Completion
2020-10-09
Completion
2020-10-09

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05386732 on ClinicalTrials.gov