Gene Expression Following Ultherapy® Treatment

Ulthera logo

Ulthera

Status

Terminated

Conditions

Skin Laxity

Treatments

Device: Ultherapy Treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT02441036
ULT-140

Details and patient eligibility

About

Up to 25 subjects will be enrolled and randomized. Randomized subjects will receive one single-side Ulthera® treatment in the pre-auricular region on the face. At each subject's scheduled facelift procedure, resected tissue will be obtained for analysis.

Full description

This is a prospective, multi-center, pilot clinical trial to evaluate the molecular changes following an Ultherapy® treatment. Subjects will be randomized to one of five treatment groups and, based on study group assignment, will receive one single-side Ultherapy® treatment at varying timepoints prior to an already planned facelift procedure. Treatment will be delivered to the pre-auricular region on one side of the face; the contralateral side will serve as control. During an already planned facelift procedure, treated and non-treated resected tissue will be obtained for analysis.

Enrollment

16 patients

Sex

All

Ages

45 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female, age 45 to 70 years.
  • Subject in good health.
  • Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
  • Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
  • Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control during the study.
  • Absence of physical or psychological conditions unacceptable to the investigator.
  • Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other Non-Steroidal Anti-Inflammatory Drug (NSAID) prior to study treatment and chronic use during the entire post-treatment study period.
  • Willingness and ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization prior to performance of any study-related procedure.

Exclusion criteria

  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Severe solar elastosis.
  • Significant scarring in the area(s) to be treated that would interfere with assessing results.
  • Open wounds or lesions in the area(s) to be treated.
  • Severe or cystic acne on the area(s) to be treated.
  • Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.)
  • Inability to understand the protocol or to give informed consent.
  • Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within four weeks prior to study participation or during the study.
  • Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
  • BMI equal to or greater than 30.
  • History of chronic drug or alcohol abuse.
  • History of autoimmune disease.
  • Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
  • Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
  • Concurrent enrollment in any study involving the use of investigational devices or drugs.
  • Current smoker or history of smoking in the last five years.
  • Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.

History of the following cosmetic treatments in the area(s) to be treated:

  • Skin tightening procedure within the past year;

Injectable filler of any type within the past:

i. 12 months for Hyaluronic acid fillers (e.g. Restylane)

ii. 12 months for Ca Hydroxyapatite fillers (e.g. Radiesse)

iii. 24 months for Long-lasting Hyaluronic acid (Juvéderm Voluma) and Poly-L-Lactic acid fillers (e.g. Sculptra)

iv. Ever for permanent fillers (e.g. Silicone, ArteFill)

c. Neurotoxins within the past three months;

d. Ablative resurfacing laser treatment within the past six months;

e. Nonablative, rejuvenative laser or light treatment within the past six months;

f. Surgical dermabrasion or deep facial peels; or

g. Facelifts within the past year.

History of using the following prescription medications:

  • Accutane or other systemic retinoids within the past six months;
  • Topical Retinoids within the past two weeks;
  • Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix);
  • Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.

Trial design

16 participants in 5 patient groups

Group 1 - 1-3 hours prior
Active Comparator group
Description:
Subjects will receive Ultherapy treatment 1-3 hours prior to tissue resection.
Treatment:
Device: Ultherapy Treatment
Group 2 - 1 day prior
Active Comparator group
Description:
Subjects will receive Ultherapy treatment 1 day prior to tissue resection.
Treatment:
Device: Ultherapy Treatment
Group 3 - 3 days prior
Active Comparator group
Description:
Subjects will receive Ultherapy treatment 3 days prior to tissue resection.
Treatment:
Device: Ultherapy Treatment
Group 4 - 7 days prior
Active Comparator group
Description:
Subjects will receive Ultherapy treatment 7 days prior to tissue resection.
Treatment:
Device: Ultherapy Treatment
Group 5 - 45 days prior
Active Comparator group
Description:
Subjects will receive Ultherapy treatment 45 days prior to tissue resection.
Treatment:
Device: Ultherapy Treatment

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems