Feasibility Study: Ulthera System for the Treatment of Rosacea

NCT01756027 | Completed

• 1 other identifier: ULT-131
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 12 subjects will be enrolled. Enrolled subjects will receive one or two Ultherapy treatments on the cheeks, depending on their assigned study group. Follow-up visits will occur 14, 30 and 90 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.

Conditions

Erythematotelangiectatic Rosacea

Keywords

Rosacea; Ulthera System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for the skin

Outcome Measures

Primary Outcomes (1)

• Improvement in Erythematotelangiectatic Rosacea of treatment area versus control

  As determined by Primary Investigator assessment

  90-days post-treatment treatment

Secondary Outcomes (1)

• Improvement in Erythematotelangiectatic Rosacea of treatment area versus control (untreated area)

  Participants will be followed for 90-days post treatment #1 (Group A) or post-treatment #2 (Group B)

Study Arms (2)

Group A

ACTIVE COMPARATOR

Ulthera System providing one treatment per cheek

Device: Ulthera System providing one treatment per cheek

Group B

ACTIVE COMPARATOR

Ulthera System providing two treatments per cheek

Device: Ulthera System providing two treatments per cheek

Interventions

Ulthera System providing one treatment per cheek DEVICE

Focused ultrasound energy delivered below the surface of the skin per cheek.

Also known as: Ultherapy™

Group A

Ulthera System providing two treatments per cheek DEVICE

Focused ultrasound energy delivered below the surface of the skin

Also known as: Ultherapy™

Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 18 to 65 years.
• Subject in good health.
• Clinical diagnosis of Erythematotelangiectatic Rosacea.
• Understands and accepts the obligation not to undergo any other procedures in the area(s) to be treated through the follow-up period.
• Absence of physical or psychological conditions unacceptable to the investigator.
• Willingness and ability to provide written consent for study-required photography and adherence to photography requirements.
• Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
• Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1.

You may not qualify if:

• Presence of an active systemic disease that may affect wound healing.
• Prominent telangiectases in the area(s) to be treated.
• History of post-inflammatory hyperpigmentation.
• Papulopustular or Phymatous Rosacea.
• Severe solar elastosis.
• Significant scarring in area(s) to be treated.
• Open wounds or lesions in the area(s) to be treated.
• Severe or cystic acne on the area(s) to be treated.
• Presence of a metal stent or implant in the area(s) to be treated.
• Inability to understand the protocol or to give informed consent.
• Microdermabrasion, or prescription level glycolic acid treatments to the intended treatment area(s) within six weeks prior to study participation or during the study.
• Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
• 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.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (1)

Cosmedica

Victoria, British Columbia, V8R 6V4, Canada

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mark Lupin, M.D.

  Cosmedica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: December 24, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 24, 2017

Record last verified: 2013-11

Locations

CA (1)