NCT01858415

Brief Summary

The TriPollar is intended for non invasive treatment of facial wrinkles and rhytides. This study was designed in order to evaluate the safety and efficacy of the TriPollar.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

August 13, 2013

Status Verified

August 1, 2013

Enrollment Period

8 months

First QC Date

April 21, 2013

Last Update Submit

August 11, 2013

Conditions

Facial Wrinkles

Outcome Measures

Primary Outcomes (2)

  • Safety of TriPollar

    Safety will be established by physician's assessment/observation of adverse events.

    6 months

  • Efficacy of TriPollar

    Efficacy will be established by level of wrinkle reduction at 3 m fu based on photos evaluation by independent physicians.

    6 months

Study Arms (1)

Single arm

EXPERIMENTAL
Device: TriPollar

Interventions

TriPollarDEVICE
Single arm

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject read, discussed and signed the Consent Form,
  • Healthy female/male aged 35 65 years,
  • Has facial wrinkles,
  • Capable of reading, understanding and following instructions of the procedure to be applied,
  • Able and willing to comply with the treatment and follow-up schedule.

You may not qualify if:

  • Listed in approved protocol, and ICF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ronald L Moy, Inc.

Beverly Hills, California, 90210, United States

Location

Reaserch Across America

Plano, Texas, 75093, United States

Location

Study Officials

  • Mira Barki, PhD

    Pollogen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2013

First Posted

May 21, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Last Updated

August 13, 2013

Record last verified: 2013-08

Locations

US(2)