Trial Outcomes & Findings for Ultherapy™ Treatment Following Sculptra® Treatment (NCT NCT01422538)

Last Updated: 2017-12-13

Results Overview

Three masked assessors reviewed pre- and 90 days post-treatment photos from 29 subjects who returned for their 90-day follow-up visit, assessing for improvement in skin laxity at 90 days post-treatment compared to baseline, i.e., lifted and tightened skin in the areas treated with the assigned study treatment based on the assigned study arm.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

90 days post-treatment

Results posted on

2017-12-13

Participant Flow

Thirty subjects were assigned to three treatment groups. Subjects NOT willing to pay for Sculptra were assigned to Treatment Group A. Subjects willing to pay for Sculptra were randomly assigned to either Treatment Group B or Treatment Group C.

Thirty subjects were enrolled and thirty subjects were treated in the study. The first subject was treated on June 28, 2011; the last subject was treated on March 28, 2012. The last patient follow-up for the trial was September 24, 2012.

Participant milestones

Participant milestones
Measure	Group A Subjects received Ultherapy® Treatment only.	Group B Subjects received Sculptra® treatment only	Group C Subjects received Sculptra® treatment and Ultherapy® treatment
Overall Study STARTED	10	10	10
Overall Study COMPLETED	10	8	8
Overall Study NOT COMPLETED	0	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A Subjects received Ultherapy® Treatment only.	Group B Subjects received Sculptra® treatment only	Group C Subjects received Sculptra® treatment and Ultherapy® treatment
Overall Study Lost to Follow-up	0	1	1
Overall Study Missed visit	0	1	1

Baseline Characteristics

Ultherapy™ Treatment Following Sculptra® Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=10 Participants Subjects received Ultherapy® Treatment only. Study subjects in Group A received approximately 400 lines of Ultherapy treatment (5.0PLUS Guideline followed).	Group B n=10 Participants Subjects received Sculptra® treatment only	Group C n=10 Participants Subjects received Sculptra® treatment and Ultherapy® treatment. Study subjects in Group C received approximately 400 lines of Ultherapy treatment (5.0PLUS Guideline followed).	Total n=30 Participants Total of all reporting groups
Age, Continuous	47 years n=5 Participants	47 years n=7 Participants	50 years n=5 Participants	48 years n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	25 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	9 participants n=5 Participants	10 participants n=7 Participants	9 participants n=5 Participants	28 participants n=4 Participants
Race/Ethnicity, Customized African American/Black	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized Native Amer. Indian/ Alaskan Native	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	30 participants n=4 Participants
Fitzpatrick Skin Type Type 1	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Fitzpatrick Skin Type Type II	4 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	16 participants n=4 Participants
Fitzpatrick Skin Type Type III	5 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	12 participants n=4 Participants
Fitzpatrick Skin Type Type IV	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Fitzpatrick Skin Type Type V	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Fitzpatrick Skin Type Type VI	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants

PRIMARY outcome

Timeframe: 90 days post-treatment

Outcome measures

Outcome measures
Measure	Group A n=10 Participants Subjects received Ultherapy® Treatment only.	Group B n=10 Participants Subjects received Sculptra® treatment only	Group C n=9 Participants Subjects received Sculptra® treatment and Ultherapy® treatment
Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs.	40 percentage of participants improved	30 percentage of participants improved	33 percentage of participants improved

SECONDARY outcome

Timeframe: 90 days post-treatment.

At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to 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.

Outcome measures

Outcome measures
Measure	Group A n=10 Participants Subjects received Ultherapy® Treatment only.	Group B n=10 Participants Subjects received Sculptra® treatment only	Group C n=9 Participants Subjects received Sculptra® treatment and Ultherapy® treatment
Overall Aesthetic Improvement at 90 Days Post-treatment PGAIS - Improved to Very Much Improved	50 percentage of participants improved	60 percentage of participants improved	67 percentage of participants improved
Overall Aesthetic Improvement at 90 Days Post-treatment SGAIS - Improved to Very Much Improved	70 percentage of participants improved	60 percentage of participants improved	56 percentage of participants improved

SECONDARY outcome

Timeframe: 180 days post-treatment

At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to 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.

Outcome measures

Outcome measures
Measure	Group A n=10 Participants Subjects received Ultherapy® Treatment only.	Group B n=9 Participants Subjects received Sculptra® treatment only	Group C n=7 Participants Subjects received Sculptra® treatment and Ultherapy® treatment
Overall Aesthetic Improvement at 180 Days Post-treatment PGAIS - Improved to Very Much Improved	30 percentage of participants improved	33 percentage of participants improved	43 percentage of participants improved
Overall Aesthetic Improvement at 180 Days Post-treatment SGAIS - Improved to Very Much Improved	70 percentage of participants improved	44 percentage of participants improved	43 percentage of participants improved

SECONDARY outcome

Timeframe: 90 days post-treatment.

Population: Data analyzed includes PSQ responses at 90 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied or Satisfied.

Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 90 days post-treatment Responses were tabulated.

Outcome measures

Outcome measures
Measure	Group A n=10 Participants Subjects received Ultherapy® Treatment only.	Group B n=10 Participants Subjects received Sculptra® treatment only	Group C n=9 Participants Subjects received Sculptra® treatment and Ultherapy® treatment
Subject Satisfaction at 90 Days Post-treatment	70 percentage of participants Satisfied	60 percentage of participants Satisfied	78 percentage of participants Satisfied

SECONDARY outcome

Timeframe: 180 days post-treatment

Population: Data analyzed includes PSQ responses at 180 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied.

Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 180 days post-treatment Responses were tabulated.

Outcome measures

Outcome measures
Measure	Group A n=10 Participants Subjects received Ultherapy® Treatment only.	Group B n=8 Participants Subjects received Sculptra® treatment only	Group C n=8 Participants Subjects received Sculptra® treatment and Ultherapy® treatment
Subject Satisfaction at 180 Days Post-treatment	70 percentage of participants Satisfied	63 percentage of participants Satisfied	38 percentage of participants Satisfied

OTHER_PRE_SPECIFIED outcome

Timeframe: During Ulthera study treatment

Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Pain assessment data were obtained from Group A and Group C subjects only.

Outcome measures

Outcome measures
Measure	Group A n=10 Participants Subjects received Ultherapy® Treatment only.	Group B n=10 Participants Subjects received Sculptra® treatment only	Group C Subjects received Sculptra® treatment and Ultherapy® treatment
Subject's Assessment of Pain Cheek	4.5 units on a scale Interval 2.0 to 8.0	4.5 units on a scale Interval 0.0 to 8.0	—
Subject's Assessment of Pain Submental	2.9 units on a scale Interval 1.0 to 5.0	2.9 units on a scale Interval 0.0 to 6.0	—
Subject's Assessment of Pain Submandibular	3.9 units on a scale Interval 1.0 to 7.0	3.3 units on a scale Interval 0.0 to 6.0	—

Adverse Events

Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Public Disclosure Manager

Merz Pharmaceuticals

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place