Status:
COMPLETED
Safety and Efficacy of the 4MD Micro Needling Device in the Treatment of Acne Scars
Lead Sponsor:
Dermapenworld
Conditions:
Acne Scarring
Eligibility:
All Genders
18-65 years
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 ...
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 wh...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 9 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05386732
Start Date
June 19 2020
End Date
October 9 2020
Last Update
May 27 2022
Active Locations (1)
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1
Dr Gabriela Casabona
Marbella, Spain, 29601