Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02444169
Other study ID # ULT-144
Secondary ID
Status Completed
Phase N/A
First received May 6, 2015
Last updated November 21, 2017
Start date April 2015
Est. completion date July 2015

Study information

Verified date August 2015
Source Merz Pharmaceuticals, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A retrospective study to evaluate the Ulthera® System for its potential interaction with toxins and fillers. Up to 500 subjects will be enrolled.


Description:

This is a retrospective, multi‐site study involving chart reviews of subjects who have received an Ultherapy treatment along with Radiesse®, Xeomin®, and/or Belotero® Balance within six months apart in the face and/or neck areas. Enrolled subjects will have received an Ultherapy treatment along with botulinum toxin A and/or filler treatment(s) within the last two years and with filler and toxin treatment occurring within 6 months before or after Ultherapy.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 70 Years
Eligibility Inclusion Criteria:

- Male or female, age 25 to 70 years.

- Subject in good health

- Subject must have had an Ultherapy treatment and Merz branded neurotoxin/filler treatments within 6 months of one or more Ultherapy treatments.

- Subject must have had both Ultherapy and neurotoxin/filler within the last 2 years (since April 2013) and with toxin/filler treatment within 6 months proximity to the Ultherapy treatment date.

- Absence of physical or psychological conditions unacceptable to the investigator, especially those whom are contraindicated to receive treatments with Ultherapy, Belotero, Radiesse and/or Xeomin.

- Subjects who are identified with good photography, must have the ability to be contacted to provide authorization to disclose photographs for usage of previously taken photography, if photos are deemed worthy of publication.

Exclusion Criteria:

- Subjects who have had any and all Ultherapy treatment(s) before April 2013.

- Subjects who have not received Radiesse®, Xeomin®, and/or Belotero Balance® within 6 months of Ultherapy treatment date.

- Psychiatric drugs and/or diseases that in the investigators opinion would impair the subject from understanding the photo consent, if photos are chosen for publication.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ultherapy
Focused ultrasound energy delivered below the surface of the skin.
Drug:
Incobotulinumtoxin A
An injectable medicine used to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults.
Device:
Radiesse
An injectable dermal filler that temporarily adds volume to help smooth moderate to severe facial wrinkles and folds, such as nasolabial folds (the creases that extend from the corner of the nose to the corner of the mouth).
Belotero Balance
An injectable dermal filler to temporarily smooth out and fill in moderate-to-severe nasolabial folds (the folds or wrinkles that go from the side of the nose to the corner of the mouth).

Locations

Country Name City State
United States Skin Research Institute Coral Gables Florida
United States Maryland Laser Skin and Vein Institute Hunt Valley Maryland
United States Aesthetic Plastic Surgical Institute Laguna Beach California
United States Dermatology Cosmetic Laser Medical Associates of La Jolla San Diego California
United States Premier Clinical Research Spokane Washington

Sponsors (1)

Lead Sponsor Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events as a Measure of Safety and Tolerability An assessment of adverse events through chart review will evaluate the safety of combination treatments of Ultherapy with toxins/fillers. Within 6 months before or after Ultherapy
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06140628 - A 28-day Clinical Study on Facial Skin Rejuvenation N/A
Completed NCT01971736 - Efficacy of Long Pulsed 1064nm Laser for Facial Skin Tightening N/A
Completed NCT01713985 - Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck N/A
Completed NCT01708252 - Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment N/A
Completed NCT01708382 - Feasibility Study: Lifting and Tightening of the Elbows N/A
Completed NCT01713998 - Treatment of the Face and Neck With Lower Ulthera System Energy Settings N/A
Completed NCT04296201 - Evaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology N/A
Completed NCT06000839 - A Safety and Effectiveness Study of CELLBOOSTER® Lift (Stabilized Booster Complex Using CHAC Technology) N/A
Completed NCT06366503 - Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation N/A
Completed NCT05929625 - Radiofrequency and Ultrasound for Improvement of Skin Laxity and Wrinkles: Efficacy and Safety Evaluation N/A
Terminated NCT01713569 - Feasibility Study: Histological Characterization After Treatment With the Ulthera® System N/A
Completed NCT01519934 - A Retrospective Study to Evaluate the Effectiveness of the Ulthera System N/A
Completed NCT05605691 - Post-Market Lower Eyelid Treatment With Renuvion in Greece N/A
Completed NCT04477187 - Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling N/A
Completed NCT05590364 - Aesthetic Performance and Tolerance of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Back of the Hands N/A
Active, not recruiting NCT06243744 - Histological Evaluation of Human Skin Bx to Assess the Effects of APR Tx as an Adjunct Procedure in Facelift Surgery N/A
Completed NCT04146584 - Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow Phase 2
Recruiting NCT05750901 - Evaluation of Fractional Ablative Laser Treatment for Skin Conditions N/A
Completed NCT04721600 - Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance N/A
Recruiting NCT06157567 - Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System N/A