The Clinical Efficacy And Safety Of SkinStylus Microneedling System
Completed · Not applicable
Conditions studied: Cicatrix, Hypertrophic
In brief
The purpose of the trial is to provide objective evidence the SkinStylus may be used safely and effectively for the treatment of ventral torso hypertrophic scars.
Key facts
- Study ID
- NCT03366194
- Run by
- Esthetic Education LLC
- People needed
- 36
- Starts
- 2017-11-15
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2022-05-11
Who can join
Age: 23 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- at least 23 years old
- shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs.
- The scar(s) must present along a flat surface suitable for application of the SkinStylus® device and consistent medical photography.
You may not qualify if…
- Pregnancy or chance of pregnancy
- Currently taking Coumadin/Warfarin® or heparin
- Diagnosis of any type of bleeding disorder
- Any history of keloid formation
- Lidocaine, tetracaine, prilocaine, bupivacaine, or benzocaine hypersensitivity
- Diagnosis of mental disorders requiring inpatient treatment
- Presence of metal implants around the proposed treatment areas
- Diagnosis of any undefined wasting disease (Cachexia for example)
- Diagnosis of an active infection in the treatment area other than mild acne
- Diagnosis of the presence of tumors or those who are being treated by chemotherapy or radiation therapy
- Diagnosis of severe cardiovascular and cerebrovascular disease
- Diagnosis of renal failure
Where it is running
- Esthetic Education LLC — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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