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Reducing Wrinkles Around the Eyes Using the Ulthera® System

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ClinicalTrials.gov Identifier: NCT01368900
Recruitment Status : Completed
First Posted : June 8, 2011
Results First Posted : July 31, 2013
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc. ( Ulthera, Inc )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Periorbital Wrinkles
Intervention Device: Ulthera® System treatment
Enrollment 68
Recruitment Details Sixty-eight subjects were enrolled at two aesthetic medical facilities. Study recruitment was initiated on March 3, 2011, and concluded on July 13, 2011. Forty-five subjects were enrolled at one study site; 23 subjects were enrolled at the second study site.
Pre-assignment Details Subjects presenting with rhytids and skin laxity in the periorbital region, Fitzpatrick Wrinkle Classification Scale (FWCS)of 3 to 7, qualified for study participation. Note: A protocol amendment restricting enrollment to FWCS scores of 3-7 occurred after 19 subjects with FWCS = 2 had been enrolled.
Arm/Group Title Treated Subjects
Hide Arm/Group Description

The FWCS, a 9 point scale used to classify wrinkle severity, was used to qualify subjects for study participation.

Score 1-3 = Fine wrinkles; 4-6 = Fine to moderate-depth wrinkles, moderate number of lines; 7-9 = Fine to deep wrinkles, Numerous lines with or without redundant skin folds.

All study subjects received an Ulthera treatment to the upper face.

Period Title: Overall Study
Started 68
Completed 61
Not Completed 7
Reason Not Completed
Lost to Follow-up             7
Arm/Group Title Treated Subjects
Hide Arm/Group Description All study subjects received an Ulthera treatment to the upper face.
Overall Number of Baseline Participants 68
Hide Baseline Analysis Population Description
Adults between 30 and 65 years of age who provided informed consent and who met the inclusion/exclusion criteria and required infraorbital, lateral orbit, and brow regions to be treated bilaterally.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Mean (Full Range) Number Analyzed 68 participants
51
(36 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
Female
66
  97.1%
Male
2
   2.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 68 participants
Caucasian 66
African American/Black 1
Asian 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 68 participants
68
Fitzpatrick Skin Type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 68 participants
Skin Type I 0
Skin Type II 18
Skin Type III 48
Skin Type IV 1
Skin Type V 1
Skin Type VI 0
[1]
Measure Description:

Skin Type I = White;very fair,red or blonde hair blue eyes;freckles;Always burns, never tans

Skin Type II = White, fair, red or blond hair; blue, hazel or green eyes;Usually burns, tans with difficulty

Skin Type III = Cream white; fair with any eye or hair color (common); Sometimes mild burn, gradually tans

Skin Type IV = Brown; typical Mediterranean Caucasian skin; Rarely burns, tans with ease

Skin Type V = Dark Brown; mid-eastern skin types; Very rarely burns, tans easily

Skin Type VI = Black; Never burns, tans very easily

1.Primary Outcome
Title Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes
Hide Description Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.
Time Frame 90 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Primary endpoint: Three masked assessors reviewed pre- and 90 days post-treatment photos, assessing each eye separately. 41 right, 42 left eye photos were found to be usable. Photos excluded had photographic lighting, focus and exposure inconsistencies obscuring key physical details making pre- vs. post-treatment photo comparisons impossible.
Arm/Group Title Subjects Treated
Hide Arm/Group Description:
All study subjects received an Ulthera treatment to the upper face.
Overall Number of Participants Analyzed 64
Measure Type: Number
Unit of Measure: percentage of participants improved
Left Eye (1.5mm Transducer) 47
Right Eye (1.0mm Transducer) 50
2.Secondary Outcome
Title Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment
Hide Description

At 60 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:

  1. = Very Much Improved
  2. = Much Improved
  3. = Improved
  4. = No Change
  5. = Worse

"Any Improvement" includes subjects assessed in categories 1-3.

Time Frame 60 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
At 60 days, the PI and subject completed a GAIS (PGAIS and SGAIS, respectively)for comparison to pre-treatment.
Arm/Group Title Subjects Treated
Hide Arm/Group Description:
All study subject received an Ulthera treatment to the upper face.
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: percentage of participants improved
PGAIS - Improved to Very Much Improved 60.6
SGAIS - Improved to Very Much Improved 66.7
3.Secondary Outcome
Title Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment
Hide Description

At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:

  1. = Very Much Improved
  2. = Much Improved
  3. = Improved
  4. = No Change
  5. = Worse

"Any Improvement" includes subjects assessed in categories 1-3.

Time Frame 90 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Data analysis was based on participants who completed a Subject Global Aesthetic Improvement scale (SGAIS) and were assessed by a study investigator via completion of a Physician Global Aesthetic Improvement scale (PGAIS)at 90 days post-treatment, per protocol.
Arm/Group Title Subjects Treated
Hide Arm/Group Description:
All study subjects received an Ulthera treatment to the upper face.
Overall Number of Participants Analyzed 67
Measure Type: Number
Unit of Measure: percentage of participants improved
PGAIS - Improved to Very Much Improved 59.7
SGAIS - Improved to Very Much Improved 67.2
4.Secondary Outcome
Title Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment
Hide Description

At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:

  1. = Very Much Improved
  2. = Much Improved
  3. = Improved
  4. = No Change
  5. = Worse

"Any Improvement" includes subjects assessed in categories 1-3.

Time Frame 180 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Data analysis was based on participants who completed a Subject Global Aesthetic Improvement scale (SGAIS) and were assessed by a study investigator via completion of a Physician Global Aesthetic Improvement scale (PGAIS)at 180 days post-treatment, per protocol.
Arm/Group Title Subjects Treated
Hide Arm/Group Description:
All study subjects received an Ulthera treatment to the upper face.
Overall Number of Participants Analyzed 61
Measure Type: Number
Unit of Measure: percentage of participants improved
PGAIS - Improved to Very Much Improved 77.0
SGAIS - Improved to Very Much Improved 68.9
5.Secondary Outcome
Title Patient Satisfaction Questionnaire 90 Days Post-treatment
Hide Description Subject satisfaction determined by scores on a patient satisfaction questionnaire at 90 days post-treatment.
Time Frame 90 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Data analyzed included subjects completing a 90 day visit and a questionnaire assessing treatment satisfaction, comparing pre-treatment and day 90 post-treatment photographic images. Responses were tabulated.
Arm/Group Title Subjects Treated
Hide Arm/Group Description:
All study subjects received an Ulthera treatment to the upper face.
Overall Number of Participants Analyzed 67
Measure Type: Number
Unit of Measure: percentage of participants Satisfied
77.6
6.Secondary Outcome
Title Patient Satisfaction Questionnaire at 180 Days Post-treatment
Hide Description Subject satisfaction determined by scores on a patient satisfaction questionnaire at 180 days post-treatment.
Time Frame 180 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Data analyzed included subjects completing a 180 day visit and a questionnaire assessing treatment satisfaction, comparing pre-treatment and day 180 post-treatment photographic images. Responses were tabulated. 60 of 61 subjects provided responses. One subject's response was missing.
Arm/Group Title Treated Subjects
Hide Arm/Group Description:
All study subjects received an Ulthera treatment to the upper face.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: percentage of participants Satisfied
72.1
7.Other Pre-specified Outcome
Title Subject Assessment of Pain
Hide Description Subjects' sensory responses to the treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale, 0-10, where 0 = no pain and 10 = worse pain possible.
Time Frame Average pain scores reported during study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The subjects' sensory responses to the treatment exposures were recorded for each anatomical region treated, using a validated numeric rating scale of 0-10 with 1 representing no pain and 10 representing the highest degree of pain.
Arm/Group Title Treated Subjects
Hide Arm/Group Description:
All study subjects received an Ulthera treatment to the upper face.
Overall Number of Participants Analyzed 68
Mean (Full Range)
Unit of Measure: units on a scale
Brow pain score
5.5
(0 to 10)
Lateral Orbit pain score
4.8
(0 to 10)
Infraorbit pain score
4.3
(0 to 10)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treated Subjects
Hide Arm/Group Description All study subjects received an Ulthera treatment to the upper face.
All-Cause Mortality
Treated Subjects
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treated Subjects
Affected / at Risk (%) # Events
Total   0/68 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treated Subjects
Affected / at Risk (%) # Events
Total   5/68 (7.35%)    
Skin and subcutaneous tissue disorders   
Visible Treatment Lines   5/68 (7.35%)  5
Indicates events were collected by systematic assessment

FWCS scores assessed globally, not per eye, leading to limited data for analysis.

FWCS protocol amended to 3+ after enrollment of 19 subjects with FWCS of 2.

Unacceptable lighting, focus, exposure making some photos impossible to evaluate.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Public Disclosure Manager
Organization: Merz Pharmaceuticals
EMail: clinicaltrials@merz.com
Layout table for additonal information
Responsible Party: Merz North America, Inc. ( Ulthera, Inc )
ClinicalTrials.gov Identifier: NCT01368900     History of Changes
Other Study ID Numbers: ULT-111
First Submitted: June 6, 2011
First Posted: June 8, 2011
Results First Submitted: April 17, 2013
Results First Posted: July 31, 2013
Last Update Posted: December 13, 2017