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

NCT05386732 | Completed

• 1 other identifier: Derma_01 1482-N-20
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The time in which redness, pain, and discomfort after treatment decreases.

  4 weeks

Interventions

Micro needling DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dermapenworld: lead

Study Sites (1)

Dr Gabriela Casabona

Marbella, 29601, Spain

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 23, 2022
• Study Start: June 19, 2020
• Primary Completion: October 9, 2020
• Study Completion: October 9, 2020
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)