Trial Outcomes & Findings for Safety and Efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine for Facial Augmentation in Asian Population (NCT NCT02565784)

NCT ID: NCT02565784

Last Updated: 2022-08-26

Results Overview

Number of improved participants according to Global Aesthetic Improvement Scale (GAIS) 6 months after initial treatment. The GAIS is a qualitative 5-graded scale evaluating aesthetic improvement: Very much improved, Much improved, Improved, No change, Worse. A participant is considered "improved" if she answers Very much improved, Much improved, or Improved.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 6 Months
• Results posted on: 2022-08-26

Participant Flow

Participant milestones

Measure	Intradermal Injection Restylane and/or Perlane Restylane: Facial tissue augmentation Perlane: Facial tissue augmentation
First Treatment STARTED	100
First Treatment 6 Months Follow-up	99
First Treatment 12 Months Follow-up	98
First Treatment COMPLETED	98
First Treatment NOT COMPLETED	2
Second Treatment STARTED	98
Second Treatment 6 Months Follow-up	97
Second Treatment 12 Months Follow-up	96
Second Treatment COMPLETED	96
Second Treatment NOT COMPLETED	2

Reasons for withdrawal

Measure	Intradermal Injection Restylane and/or Perlane Restylane: Facial tissue augmentation Perlane: Facial tissue augmentation
First Treatment Adverse Event	1
First Treatment Withdrawal by Subject	1
Second Treatment Withdrawal by Subject	2

Baseline Characteristics

Safety and Efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine for Facial Augmentation in Asian Population

Baseline characteristics by cohort

Measure	Intradermal Injection n=100 Participants Restylane and/or Perlane Restylane: Facial tissue augmentation Perlane: Facial tissue augmentation
Age, Continuous	39.7 years STANDARD_DEVIATION 5.4 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Taiwan	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Number of improved participants according to Global Aesthetic Improvement Scale (GAIS) 6 months after initial treatment.

The GAIS is a qualitative 5-graded scale evaluating aesthetic improvement: Very much improved, Much improved, Improved, No change, Worse.

A participant is considered "improved" if she answers Very much improved, Much improved, or Improved.

Outcome measures

Measure	Intradermal Injection n=99 Participants Restylane and/or Perlane Restylane: Facial tissue augmentation Perlane: Facial tissue augmentation	Left Nasolabial Fold Intradermal injection Restylane and/or Perlane Restylane: Facial tissue augmentation Perlane: Facial tissue augmentation
Percentage of Participants Improved in "Global Facial Aesthetic Appearance" - Judged by Participant	95 percentage of participants Interval 89.0 to 98.0	—

SECONDARY outcome

Timeframe: 6 and 12 Months after first and second treatment, respectively

Population: In total, 88 participants were injected in the right NLF and 86 participants were injected in the left NLF

The Merz aesthetic scale for nasolabial folds (NLFs) is a validated photograph-based outcome instrument designed specifically for assessment of NLFs. The scale is graded 0-4 where 0 is "No folds" and 4 is "Very severe folds".

A participant is considered improved if she scores at least one grade improvement from baseline.

Outcome measures

Measure	Intradermal Injection n=88 Participants Restylane and/or Perlane Restylane: Facial tissue augmentation Perlane: Facial tissue augmentation	Left Nasolabial Fold n=86 Participants Intradermal injection Restylane and/or Perlane Restylane: Facial tissue augmentation Perlane: Facial tissue augmentation
Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator 6 Months after first treatment	54 percentage of participants Interval 43.0 to 65.0	65 percentage of participants Interval 54.0 to 75.0
Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator 12 Months after first treatment	47 percentage of participants Interval 36.0 to 58.0	46 percentage of participants Interval 35.0 to 57.0
Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator 6 Months after second treatment	65 percentage of participants Interval 54.0 to 75.0	62 percentage of participants Interval 51.0 to 72.0
Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator 12 Months after second treatment	54 percentage of participants Interval 42.0 to 65.0	55 percentage of participants Interval 44.0 to 66.0

SECONDARY outcome

Timeframe: 6 and 12 Months after first and second treatment, respectively

Population: All 100 participants were injected in the upper cheeks, but 1 participant was not injected in left upper cheek at baseline.

The Merz aesthetic scale for upper cheek fullness is a validated photograph-based outcome instrument designed specifically for assessing cheek fullness. The scale is graded 0-4 where 0 is "Full upper cheek" and 4 is "Very severely sunken upper cheek".

A participant is assessed as improved if she scores at least one grade improvement from baseline.

Outcome measures

Measure	Intradermal Injection n=100 Participants Restylane and/or Perlane Restylane: Facial tissue augmentation Perlane: Facial tissue augmentation	Left Nasolabial Fold n=99 Participants Intradermal injection Restylane and/or Perlane Restylane: Facial tissue augmentation Perlane: Facial tissue augmentation
Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator 6 Months after first treatment	66 percentage of participants Interval 55.0 to 75.0	67 percentage of participants Interval 57.0 to 77.0
Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator 12 Months after first treatment	38 percentage of participants Interval 28.0 to 48.0	43 percentage of participants Interval 33.0 to 54.0
Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator 6 Months after second treatment	77 percentage of participants Interval 68.0 to 85.0	78 percentage of participants Interval 69.0 to 86.0
Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator 12 Months after second treatment	69 percentage of participants Interval 59.0 to 78.0	71 percentage of participants Interval 60.0 to 79.0

Adverse Events

Intradermal Injection

Serious events: 5 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intradermal Injection n=100 participants at risk Restylane and/or Perlane Restylane: Facial tissue augmentation Perlane: Facial tissue augmentation
Infections and infestations Chronic paranasal sinusitis	1.0% 1/100 • Number of events 1 • 2 years, 4 months Each subject was to be questioned about AEs at each study visit following the Screening Visit. The question to be asked was:"Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during an examination or from a laboratory test, observations made by the study site personnel, subject diaries, or spontaneous reports from subjects or their relatives.
Infections and infestations Herpes simplex progenitalis	1.0% 1/100 • Number of events 1 • 2 years, 4 months Each subject was to be questioned about AEs at each study visit following the Screening Visit. The question to be asked was:"Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during an examination or from a laboratory test, observations made by the study site personnel, subject diaries, or spontaneous reports from subjects or their relatives.
Respiratory, thoracic and mediastinal disorders Hemoptysis	1.0% 1/100 • Number of events 1 • 2 years, 4 months Each subject was to be questioned about AEs at each study visit following the Screening Visit. The question to be asked was:"Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during an examination or from a laboratory test, observations made by the study site personnel, subject diaries, or spontaneous reports from subjects or their relatives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papilloma (benign)	1.0% 1/100 • Number of events 1 • 2 years, 4 months Each subject was to be questioned about AEs at each study visit following the Screening Visit. The question to be asked was:"Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during an examination or from a laboratory test, observations made by the study site personnel, subject diaries, or spontaneous reports from subjects or their relatives.
Reproductive system and breast disorders Left ovary tumor with endometrial polyps	1.0% 1/100 • Number of events 1 • 2 years, 4 months Each subject was to be questioned about AEs at each study visit following the Screening Visit. The question to be asked was:"Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during an examination or from a laboratory test, observations made by the study site personnel, subject diaries, or spontaneous reports from subjects or their relatives.

Other adverse events

Measure	Intradermal Injection n=100 participants at risk Restylane and/or Perlane Restylane: Facial tissue augmentation Perlane: Facial tissue augmentation
Infections and infestations Nasopharyngitis	18.0% 18/100 • Number of events 24 • 2 years, 4 months Each subject was to be questioned about AEs at each study visit following the Screening Visit. The question to be asked was:"Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during an examination or from a laboratory test, observations made by the study site personnel, subject diaries, or spontaneous reports from subjects or their relatives.
Infections and infestations Upper respiratory tract infection	10.0% 10/100 • Number of events 13 • 2 years, 4 months Each subject was to be questioned about AEs at each study visit following the Screening Visit. The question to be asked was:"Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during an examination or from a laboratory test, observations made by the study site personnel, subject diaries, or spontaneous reports from subjects or their relatives.
Skin and subcutaneous tissue disorders Acne	6.0% 6/100 • Number of events 10 • 2 years, 4 months Each subject was to be questioned about AEs at each study visit following the Screening Visit. The question to be asked was:"Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during an examination or from a laboratory test, observations made by the study site personnel, subject diaries, or spontaneous reports from subjects or their relatives.
General disorders Implant site bruising	6.0% 6/100 • Number of events 7 • 2 years, 4 months Each subject was to be questioned about AEs at each study visit following the Screening Visit. The question to be asked was:"Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during an examination or from a laboratory test, observations made by the study site personnel, subject diaries, or spontaneous reports from subjects or their relatives.
General disorders Implant site pain	5.0% 5/100 • Number of events 13 • 2 years, 4 months Each subject was to be questioned about AEs at each study visit following the Screening Visit. The question to be asked was:"Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during an examination or from a laboratory test, observations made by the study site personnel, subject diaries, or spontaneous reports from subjects or their relatives.

Additional Information

Clinical Project Manager

Q-Med AB

Phone: +46184749000

Email: reception.seupp@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place