Clinical trial NCT03366194: The Clinical Efficacy And Safety Of SkinStylus Microneedling System
Official title: The Clinical Efficacy And Safety Of SkinStylus Microneedling System for Ventral Torso Hypertrophic Scars: Clinical Results With 30 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cicatrix, Hypertrophic
Lead sponsor: Esthetic Education LLC
Sponsor class: INDUSTRY
First posted: 2017-12-08
Enrollment: 36
Sex: ALL
Minimum age (years): 23
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participant shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs. At the conclusion of the trial all participants shall be provided with a cross over treatment on the non-treated portion of the scar identical to that which was provided within the trial for the purpose of "evening" the ventral torso hypertrophic scar.
Primary purpose: TREATMENT

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 for use and specifically no new risks will be introduced.
2. Each participant shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs. At the conclusion of the trial all participants shall be provided with a cross over treatment on the non-treated portion of the scar identical to that which was provided within the trial for the purpose of "evening" the ventral torso hypertrophic scar. This is entirely voluntary and participants may decline the treatment if they wish.

Eligibility criteria: Inclusion Criteria:

1. at least 23 years old
2. shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs.
3. The scar(s) must present along a flat surface suitable for application of the SkinStylus® device and consistent medical photography.

Exclusion Criteria:

1. Pregnancy or chance of pregnancy
2. Currently taking Coumadin/Warfarin® or heparin
3. Diagnosis of any type of bleeding disorder
4. Any history of keloid formation
5. Lidocaine, tetracaine, prilocaine, bupivacaine, or benzocaine hypersensitivity
6. Diagnosis of mental disorders requiring inpatient treatment
7. Presence of metal implants around the proposed treatment areas
8. Diagnosis of any undefined wasting disease (Cachexia for example)
9. Diagnosis of an active infection in the treatment area other than mild acne
10. Diagnosis of the presence of tumors or those who are being treated by chemotherapy or radiation therapy
11. Diagnosis of severe cardiovascular and cerebrovascular disease
12. Diagnosis of renal failure

Primary outcomes:
measure: Number of Participants With Improvement Assessed Using the VAS Scar Scoring System
timeFrame: 90 days from date of last treatment
Secondary outcomes:
measure: Number of Patients Self-Reporting Improvement Using the Validated Self-Assessed Scar Improvement Scale Satisfaction Survey
timeFrame: 90 days from date of last treatment
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Esthetic Education LLC
state: Arizona
Study officials:
affiliation: Principal Investigator for Esthetic Education LLC
name: Toni Stockton, MD
role: PRINCIPAL_INVESTIGATOR
References: