Trial Outcomes & Findings for An Open-label Study of Poly-l-lactic Acid for Correction of Wrinkles in the décolletage Area (NCT NCT05538728)
NCT ID: NCT05538728
Last Updated: 2024-08-20
Results Overview
Responder was defined as participants having at least one grade improvement from baseline. GDS was a validated 5-point scale used to assess the severity of lines and wrinkles in the décolletage area: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (very severe). Higher score meant very severe lines and wrinkles in the décolletage area.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
At Month 9
Results posted on
2024-08-20
Participant Flow
This study was conducted at the United States from 31 August 2022 to 08 August 2023.
A total of 30 participants were enrolled and treated in this study.
Participant milestones
| Measure |
Sculptra 8ml
Participants received first treatment injection sub-dermally with Sculptra 8 milliliters (ml; current labeled total volume: reconstituted with 8 mL sterile water for injection \[SWFI\] + 1 mL lidocaine hydrochloride 2 percent \[%\]) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on Galderma Decolletage Scale (GDS) and best correction that achieved as agreed upon by the Treating Investigator and the participant.
|
Sculptra 17ml
Participants received first treatment injection sub-dermally with Sculptra 17ml (reconstituted with 17 mL SWFI + 1 mL lidocaine hydrochloride 2%) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on GDS and best correction that achieved as agreed upon by the Treating Investigator and the participant.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Sculptra 8ml
Participants received first treatment injection sub-dermally with Sculptra 8 milliliters (ml; current labeled total volume: reconstituted with 8 mL sterile water for injection \[SWFI\] + 1 mL lidocaine hydrochloride 2 percent \[%\]) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on Galderma Decolletage Scale (GDS) and best correction that achieved as agreed upon by the Treating Investigator and the participant.
|
Sculptra 17ml
Participants received first treatment injection sub-dermally with Sculptra 17ml (reconstituted with 17 mL SWFI + 1 mL lidocaine hydrochloride 2%) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on GDS and best correction that achieved as agreed upon by the Treating Investigator and the participant.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
An Open-label Study of Poly-l-lactic Acid for Correction of Wrinkles in the décolletage Area
Baseline characteristics by cohort
| Measure |
Sculptra 8ml
n=16 Participants
Participants received first treatment injection sub-dermally with Sculptra 8 milliliters (ml; current labeled total volume: reconstituted with 8 mL sterile water for injection \[SWFI\] + 1 mL lidocaine hydrochloride 2 percent \[%\]) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on Galderma Decolletage Scale (GDS) and best correction that achieved as agreed upon by the Treating Investigator and the participant.
|
Sculptra 17ml
n=14 Participants
Participants received first treatment injection sub-dermally with Sculptra 17ml (reconstituted with 17 mL SWFI + 1 mL lidocaine hydrochloride 2%) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on GDS and best correction that achieved as agreed upon by the Treating Investigator and the participant.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 9.77 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 8.88 • n=7 Participants
|
54.0 years
STANDARD_DEVIATION 9.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 9Population: Intent to treat (ITT) population Included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme.
Responder was defined as participants having at least one grade improvement from baseline. GDS was a validated 5-point scale used to assess the severity of lines and wrinkles in the décolletage area: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (very severe). Higher score meant very severe lines and wrinkles in the décolletage area.
Outcome measures
| Measure |
Sculptra 8ml
n=16 Participants
Participants received first treatment injection sub-dermally with Sculptra 8 milliliters (ml; current labeled total volume: reconstituted with 8 mL sterile water for injection \[SWFI\] + 1 mL lidocaine hydrochloride 2 percent \[%\]) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on Galderma Decolletage Scale (GDS) and best correction that achieved as agreed upon by the Treating Investigator and the participant.
|
Sculptra 17ml
n=14 Participants
Participants received first treatment injection sub-dermally with Sculptra 17ml (reconstituted with 17 mL SWFI + 1 mL lidocaine hydrochloride 2%) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on GDS and best correction that achieved as agreed upon by the Treating Investigator and the participant.
|
|---|---|---|
|
Percentage of Responders on the Galderma Décolletage Scale (GDS), as Assessed Live by the Treating Investigator, at Month 9
|
93.8 percentage of Participants
Interval 69.8 to 99.8
|
78.6 percentage of Participants
Interval 49.2 to 95.3
|
SECONDARY outcome
Timeframe: At Month 6Population: ITT population Included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Responder was defined as participants having at least one grade improvement from baseline. GDS was a validated 5-point scale used to assess the severity of lines and wrinkles in the décolletage area: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (very severe). Higher score meant very severe lines and wrinkles in the décolletage area.
Outcome measures
| Measure |
Sculptra 8ml
n=15 Participants
Participants received first treatment injection sub-dermally with Sculptra 8 milliliters (ml; current labeled total volume: reconstituted with 8 mL sterile water for injection \[SWFI\] + 1 mL lidocaine hydrochloride 2 percent \[%\]) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on Galderma Decolletage Scale (GDS) and best correction that achieved as agreed upon by the Treating Investigator and the participant.
|
Sculptra 17ml
n=12 Participants
Participants received first treatment injection sub-dermally with Sculptra 17ml (reconstituted with 17 mL SWFI + 1 mL lidocaine hydrochloride 2%) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on GDS and best correction that achieved as agreed upon by the Treating Investigator and the participant.
|
|---|---|---|
|
Percentage of Responders on the Galderma Décolletage Scale, as Assessed Live by the Treating Investigator, at Month 6
|
93.3 percentage of Participants
Interval 68.1 to 99.8
|
100 percentage of Participants
Interval 73.5 to 100.0
|
SECONDARY outcome
Timeframe: At Month 6 and 9Population: ITT population Included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Responder was defined as participants achieving 'very much improved', 'much improved' or "Improved" on GAIS compared to baseline. The 7-graded GAIS was used by the participant to live assess the severity of lines and wrinkles by responding to the question: "Please choose the response below that best describes the overall change in the appearance of your upper chest area since you received the study treatment " by using the respective categorical scale as follows: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. In this outcome measure, percentage of participants who achieved at least 'Improved' on the GAIS assessed by participant at Months 6 and 9 were reported.
Outcome measures
| Measure |
Sculptra 8ml
n=15 Participants
Participants received first treatment injection sub-dermally with Sculptra 8 milliliters (ml; current labeled total volume: reconstituted with 8 mL sterile water for injection \[SWFI\] + 1 mL lidocaine hydrochloride 2 percent \[%\]) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on Galderma Decolletage Scale (GDS) and best correction that achieved as agreed upon by the Treating Investigator and the participant.
|
Sculptra 17ml
n=12 Participants
Participants received first treatment injection sub-dermally with Sculptra 17ml (reconstituted with 17 mL SWFI + 1 mL lidocaine hydrochloride 2%) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on GDS and best correction that achieved as agreed upon by the Treating Investigator and the participant.
|
|---|---|---|
|
Percentage of Responders Who Achieved At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant at Months 6 and 9
At Month 6
|
100 percentage of Participants
Interval 78.2 to 100.0
|
100 percentage of Participants
Interval 73.5 to 100.0
|
|
Percentage of Responders Who Achieved At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant at Months 6 and 9
At Month 9
|
100 percentage of Participants
Interval 78.2 to 100.0
|
91.7 percentage of Participants
Interval 61.5 to 99.8
|
SECONDARY outcome
Timeframe: At Months 6 and 9Population: ITT population Included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme. Here, 'number analyzed, n' signifies participants evaluable for specified time points.
Responder was defined as participants achieving 'very much improved', 'much improved' or "Improved" on GAIS compared to baseline. The 7-graded GAIS was used by the Treating Investigator to live assess the severity of lines and wrinkles by responding to the question: "Please choose the response below that best describes the overall change in the appearance of your upper chest area since you received the study treatment " by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. In this outcome measure, percentage of participants who achieved at least 'Improved' on the GAIS assessed by treating investigator at Months 6 and 9 were reported.
Outcome measures
| Measure |
Sculptra 8ml
n=15 Participants
Participants received first treatment injection sub-dermally with Sculptra 8 milliliters (ml; current labeled total volume: reconstituted with 8 mL sterile water for injection \[SWFI\] + 1 mL lidocaine hydrochloride 2 percent \[%\]) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on Galderma Decolletage Scale (GDS) and best correction that achieved as agreed upon by the Treating Investigator and the participant.
|
Sculptra 17ml
n=13 Participants
Participants received first treatment injection sub-dermally with Sculptra 17ml (reconstituted with 17 mL SWFI + 1 mL lidocaine hydrochloride 2%) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on GDS and best correction that achieved as agreed upon by the Treating Investigator and the participant.
|
|---|---|---|
|
Percentage of Responders With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Treating Investigator at Months 6 and 9
At Month 9
|
100 percentage of Participants
Interval 78.2 to 100.0
|
100 percentage of Participants
Interval 75.3 to 100.0
|
|
Percentage of Responders With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Treating Investigator at Months 6 and 9
At Month 6
|
100 percentage of Participants
Interval 78.2 to 100.0
|
100 percentage of Participants
Interval 73.5 to 100.0
|
Adverse Events
Sculptra 8ml
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Sculptra 17ml
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sculptra 8ml
n=16 participants at risk
Participants received first treatment injection sub-dermally with Sculptra 8 milliliters (ml; current labeled total volume: reconstituted with 8 mL sterile water for injection \[SWFI\] + 1 mL lidocaine hydrochloride 2 percent \[%\]) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on Galderma Decolletage Scale (GDS) and best correction that achieved as agreed upon by the Treating Investigator and the participant.
|
Sculptra 17ml
n=14 participants at risk
Participants received first treatment injection sub-dermally with Sculptra 17ml (reconstituted with 17 mL SWFI + 1 mL lidocaine hydrochloride 2%) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on GDS and best correction that achieved as agreed upon by the Treating Investigator and the participant.
|
|---|---|---|
|
General disorders
Injection site nodule
|
0.00%
0/16 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
7.1%
1/14 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.2%
1/16 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
0.00%
0/14 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
|
General disorders
Application site dermatitis
|
0.00%
0/16 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
7.1%
1/14 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
|
Infections and infestations
COVID-19
|
6.2%
1/16 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
0.00%
0/14 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
7.1%
1/14 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
|
Infections and infestations
Respiratory tract infection
|
6.2%
1/16 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
0.00%
0/14 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
0.00%
0/14 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/16 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
7.1%
1/14 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
|
Investigations
SARS-CoV-2 test positive
|
6.2%
1/16 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
0.00%
0/14 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/16 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
7.1%
1/14 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/16 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
7.1%
1/14 • From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
|
Additional Information
Clinical Project Manager
Galderma Research and Development, LLC
Phone: 817-961-5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place