L90.5
Conditions
Interventions
Group 1: 56 patients
treatment: facial atrophic acne scars
4 microneedle treatments in a gap of 30 days
automated medical devices revice and revive mn
objective: reduction of acne scars, evaluation scheme: Before every treatment and 30 days after the last treatment a physician evaluates the scars according to the Goodman-Baron Grading scale
During the whole study adverse events are documented
target parameter: see primary and secondary outcome.
Sponsors
MT.DERM GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary endpoints are: - Significant reduction of scarring at assessment before 4th treatment versus baseline (first treatment) according to Goodman and Baron Grading Scale - 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 - Down time: The time in which redness/swelling, pain, and discomfort after treatment goes down - Specific side effects as assessed by patient diaries - Safety: occurrence of AE | — |
Countries
Germany
Contacts
Public ContactCordula Reuter
MT.DERM GmbH
Outcome results
None listed