Status:
COMPLETED
The Clinical Efficacy And Safety Of SkinStylus Microneedling System
Lead Sponsor:
Esthetic Education LLC
Conditions:
Cicatrix, Hypertrophic
Eligibility:
All Genders
23+ years
Phase:
NA
Brief Summary
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.
Detailed Description
1. The SkinStylus has been designated as a non-significant risk and therefore will be granted an Investigational Device Exemption (IDE). There are no meaningful changes to the SkinStylus® instructions...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03366194
Start Date
November 15 2017
End Date
December 1 2018
Last Update
May 11 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Esthetic Education LLC
Scottsdale, Arizona, United States, 85260