Trial Outcomes & Findings for Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate and Severe Nasolabial Folds (NCT NCT02432742)

Last Updated: 2022-08-26

Results Overview

The Wrinkle Severity Rating Scale (WSRS) is a 5-graded scale with grades 1-5 ranging from absent (1) to extreme (5). A clinical significant improvement is defined as at least 1 grade improvement (lowering in grade).

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

6 months

Results posted on

2022-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	Restylane Perlane in One NLF and Restylane in the Other NLF Single injection and optional touch up injection with Restylane Perlane in one nasolabial fold (NLF) and single injection and optional touch up injection with Restylane in the other NLF (split-face design). Restylane Perlane: Intradermal injection Restylane: Intradermal injection
Overall Study STARTED	100
Overall Study COMPLETED	95
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate and Severe Nasolabial Folds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Restylane Perlane in One NLF and Restylane in the Other NLF n=100 Participants Single injection and optional touch up injection with Restylane Perlane in one NLF and single injection and optional touch up injection with Restylane in the other NLF (split-face design). Restylane Perlane: Intradermal injection, Restylane: Intradermal injection
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Sex · Female	98 Participants n=5 Participants
Sex: Female, Male Sex · Male	2 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Han Chinese	97 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Other (Manchu, Tujia, Hui)	3 Participants n=5 Participants
Region of Enrollment China	100 Participants n=5 Participants
WSRS score of either 3 on both sides or 4 on both sides as assessed by an Independent Evaluator	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Split-face design; 100 participants received treatment with Restylane Perlane in one NLF and treatment with Restylane in the other NLF.

Outcome measures

Outcome measures
Measure	Restylane Perlane NLFs n=100 Participants Single injection and optional touch up injection with Restylane Perlane in NLF Restylane Perlane: Intradermal injection	Restylane NLFs n=100 Participants Single injection and optional touch up injection with Restylane in NLF Restylane: Intradermal injection
Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months	-0.03 units on a scale Standard Deviation 0.03	0.03 units on a scale Standard Deviation 0.03

Adverse Events

Restylane Perlane in One NLF and Restylane in the Other NLF

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Restylane Perlane in One NLF and Restylane in the Other NLF n=100 participants at risk Single injection and optional touch up injection with Restylane Perlane in one NLF and single injection and optional touch up injection with Restylane in the other NLF (split-face design). Restylane Perlane: Intradermal injection, Restylane: Intradermal injection
Infections and infestations Multi organ failure, infection	1.0% 1/100 • Number of events 1
Surgical and medical procedures Bladder lesion excision	1.0% 1/100 • Number of events 1

Other adverse events

Other adverse events
Measure	Restylane Perlane in One NLF and Restylane in the Other NLF n=100 participants at risk Single injection and optional touch up injection with Restylane Perlane in one NLF and single injection and optional touch up injection with Restylane in the other NLF (split-face design). Restylane Perlane: Intradermal injection, Restylane: Intradermal injection
Infections and infestations Nasopharyngitis	9.0% 9/100 • Number of events 10
Infections and infestations Upper respiratory tract infection	5.0% 5/100 • Number of events 5
General disorders Implant site bruising	1.0% 1/100 • Number of events 1

Additional Information

Clinical Project Manager

Q-Med AB

Phone: +46184749000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place