---
title: Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Wrinkles Around the Eyes
nct_id: NCT00747422
overall_status: COMPLETED
phase: NA
sponsor: Ulthera, Inc
study_type: INTERVENTIONAL
primary_condition: Periorbital Wrinkles
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00747422.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00747422"
ct_last_update_post_date: 2017-11-24
last_seen_at: "2026-05-12T07:08:59.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Wrinkles Around the Eyes

**Official Title:** Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Periorbital Wrinkles

**NCT ID:** [NCT00747422](https://clinicaltrials.gov/study/NCT00747422)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** Ulthera, Inc
- **Conditions:** Periorbital Wrinkles
- **Start Date:** 2008-07
- **Completion Date:** 2009-05
- **CT.gov Last Update:** 2017-11-24

## Brief Summary

The purpose of this study is to look at how safe and effective the Ulthera ultrasound system is at reducing the appearance of wrinkles when used with subjects who have wrinkles around the eyes.

## Detailed Description

The purpose of this prospective, multi-center, single treatment, clinical trial is to evaluate the effectiveness and safety of the Ulthera™ System for the non-invasive treatment of periorbital wrinkles and rhytids.

## Eligibility

- **Minimum age:** 40 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Male or female, aged 40 to 70 years
* Subject in good health
* Desire improvement in periorbital wrinkles
* Subject provides informed consent and agrees to attend follow-up visits
* Subject signs a HIPPA authorization

Exclusion Criteria:

* Pregnant or lactating
* Has an active systemic or local skin disease that may alter wound healing
* Has significant scarring in test areas
* Has significant open facial wounds or lesions
* Has severe or cystic acne on the face
* Has a metal stent or implant in the face area
* Is a current smoker or has a history of smoking in last 10 years
```

## Arms

- **I** (EXPERIMENTAL)

## Interventions

- **Ulthera™ System** (DEVICE) — ultrasound treatment

## Primary Outcomes

- **reduction of periorbital wrinkles** _(time frame: 3 and 6 months)_

## Locations (4)

- Scripps Clinic Carmel Valley, Division of Laser and Cosmetic Dermatology, San Diego, California, United States
- Northwestern University Department of Dermatology, Chicago, Illinois, United States
- SkinCare Physicians, Chestnut Hill, Massachusetts, United States
- Zel Skin and Laser Specialists, Edina, Minnesota, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.scripps clinic carmel valley, division of laser and cosmetic dermatology|san diego|california|united states` — added _(2026-05-12)_
- `locations.northwestern university department of dermatology|chicago|illinois|united states` — added _(2026-05-12)_
- `locations.skincare physicians|chestnut hill|massachusetts|united states` — added _(2026-05-12)_
- `locations.zel skin and laser specialists|edina|minnesota|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00747422.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00747422*  
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