NCT01701440

Brief Summary

In this study we propose to test the Biofusionary Bebe in order to reduce skin laxity and improve contour and cosmesis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

October 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

October 11, 2012

Status Verified

October 1, 2012

Enrollment Period

9 months

First QC Date

October 3, 2012

Last Update Submit

October 10, 2012

Conditions

Wrinkles and Rhytides

Outcome Measures

Primary Outcomes (1)

  • Improvement in cosmesis

    Improvement in cosmesis will be assessed by scoring photographs taken before and 1 month after treatment. Circumference changes will be measured and compared

    1 month

Secondary Outcomes (1)

  • Improvement in cosmesis

    3 months

Interventions

Biofusionary BebeDEVICE

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female 21 to 65 years old,
  • Clinically appreciable skin laxity on the abdomen (including flank), face, neck, hips, thighs, upper arms \& buttocks as determined by the study investigator,
  • For females, post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study,
  • Apparently healthy,
  • Informed consent signed by the subject.

You may not qualify if:

  • History of skin hypersensitivity,
  • Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex) in the treatment area,
  • Subjects with pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,
  • Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site,
  • The current or recent use (within the past 12 months) of isotretinoin,
  • Pregnancy,
  • Infectious diseases (such as HIV) present,
  • Are a tobacco smoker,
  • Insulin dependent diabetic subjects,
  • Oxygen dependent subjects,
  • Subjects with severe chronic illness, scleroderma, or lupus,
  • Subjects with open sores or scars in the treatment region, or
  • Subjects with ischemia in the treatment region.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physicians Laser and Dermatolgy Institute of Chicago,LLC

Chicago, Illinois, 60611, United States

Location

Study Officials

  • Jerome Garden, MD

    Physicians Laser and Dermatology Institute of Chicago

    PRINCIPAL INVESTIGATOR

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

October 3, 2012

First Posted

October 5, 2012

Study Start

October 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

October 11, 2012

Record last verified: 2012-10

Locations

US(1)