Post-Market Clinical Follow-Up study for Microneedling devices revive mn” and revive”
- Conditions
- L90.5Scar conditions and fibrosis of skin
- Registration Number
- DRKS00013187
- Lead Sponsor
- MT.DERM GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 56
presence of post-acne facial atrophic scars,
- age between 18–65 years,
- voluntary participation,
- ability to comprehend and provide informed consent,
- agreement not to participate in another clinical study and to undergo other treatments during the study
- agreement NOT to use any topical agents that influence appearing of acne scarring, such as peeling or active ingredients like Retinoids during the study period.
- agreement NOT to undergo any aesthetic treatments (such as Botox, fillers, microdermabrasion, laser treatment etc.) in the treatment area, during the study period.
- Haemophilia / bleeding disorder
- Uncontrolled diabetes mellitus
- Treatment of eye ball or mucosa
- Treatment of skin areal 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 cortico-steroids
- Systemic infection (e.g. hepatitis) or acute skin infection (e.g. herpes)
- Any form of active acne
- Allergic reaction to topic and local anesthetics
- Pregnancy and lactation
- Eczema, exanthema or open wounds
- Scars not older than 6 months
- Skin areal with plastic surgery in the past 12 months
- Skin areal with filler injection in the past 6 months.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is to show a significant reduction (for one grade according to Goodman and Baron Grading Scale) of scarring three months after last treatment versus baseline (before treatment).
- Secondary Outcome Measures
Name Time Method Secondary endpoints are:<br>-Significant reduction of scarring at assessment before 4th treatment versus baseline (first treatment) according to Goodman and Baron Grading Scale<br>-Significant reduction of scarring three months after last treatment versus baseline (first treatment) according to Goodman and Baron Grading Scale in subgroups according to Jacob<br>-Down time: The time in which redness/swelling, pain, and discomfort after treatment goes down<br>-Specific side effects as assessed by patient diaries<br>-Safety: occurrence of AE<br>