Trial Outcomes & Findings for Pain and Safety of Restylane Perlane With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds (NCT NCT03174132)

Results Overview

Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane at the time of injection. VAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the right end. The distance in mm from the left end (no pain) to the participant's VAS mark is measured with a standard ruler.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

At the time of injection

Results posted on

2022-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	Restylane Perlane Lidocaine and Restylane Perlane Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1 Restylane Perlane Lidocaine: Intradermal injection Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1 Restylane Perlane: Intradermal injection
Overall Study STARTED	70
Overall Study COMPLETED	70
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pain and Safety of Restylane Perlane With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Restylane Perlane Lidocaine and Restylane Perlane n=70 Participants Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1 Restylane Perlane Lidocaine: Intradermal injection Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1 Restylane Perlane: Intradermal injection
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=93 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants
Age, Continuous	50.2 years STANDARD_DEVIATION 10 • n=93 Participants
Sex: Female, Male Female	60 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants
Race/Ethnicity, Customized Han Chinese	70 Participants n=93 Participants
Region of Enrollment Taiwan	70 participants n=93 Participants

PRIMARY outcome

Timeframe: At the time of injection

Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane at the time of injection. VAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the right end. The distance in mm from the left end (no pain) to the participant's VAS mark is measured with a standard ruler.

Outcome measures

Outcome measures
Measure	Restylane Perlane Lidocaine and Restylane Perlane n=70 Participants Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1 Restylane Perlane Lidocaine: Intradermal injection Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1 Restylane Perlane: Intradermal injection
Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS)	87.1 percentage of subjects Interval 77.0 to 93.9

SECONDARY outcome

Timeframe: 15, 30, 45, and 60 minutes after injection

Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane at 15, 30, 45 and 60 minutes after injection. VAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the right end. The distance in mm from the left end (no pain) to the participant's VAS mark is measured with a standard ruler.

Outcome measures

Outcome measures
Measure	Restylane Perlane Lidocaine and Restylane Perlane n=70 Participants Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1 Restylane Perlane Lidocaine: Intradermal injection Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1 Restylane Perlane: Intradermal injection
Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) after 15 minutes	64.3 percentage of subjects Interval 51.9 to 75.4
Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) after 30 minutes	42.9 percentage of subjects Interval 31.1 to 55.3
Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) after 45 minutes	31.4 percentage of subjects Interval 20.9 to 43.6
Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) after 60 minutes	24.3 percentage of subjects Interval 14.8 to 36.0

Adverse Events

Restylane Perlane Lidocaine and Restylane Perlane

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Restylane Perlane Lidocaine and Restylane Perlane n=70 participants at risk Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1 Restylane Perlane Lidocaine: Intradermal injection Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1 Restylane Perlane: Intradermal injection
Nervous system disorders Presyncope	1.4% 1/70 • Number of events 1 • Maximum 32 days for each participant (from screening visit to last visit). AEs collection began after the informed consent form had been signed. Each subject was questioned about AEs at each clinical visit following the screening visit. The question 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 each examination or from a laboratory test, observations by the study personnel, subject diaries or spontaneous reports from the subjects.
Infections and infestations Oral herpes	1.4% 1/70 • Number of events 1 • Maximum 32 days for each participant (from screening visit to last visit). AEs collection began after the informed consent form had been signed. Each subject was questioned about AEs at each clinical visit following the screening visit. The question 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 each examination or from a laboratory test, observations by the study personnel, subject diaries or spontaneous reports from the subjects.
Nervous system disorders Headache	1.4% 1/70 • Number of events 1 • Maximum 32 days for each participant (from screening visit to last visit). AEs collection began after the informed consent form had been signed. Each subject was questioned about AEs at each clinical visit following the screening visit. The question 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 each examination or from a laboratory test, observations by the study personnel, subject diaries or spontaneous reports from the subjects.
Respiratory, thoracic and mediastinal disorders Cough	1.4% 1/70 • Number of events 1 • Maximum 32 days for each participant (from screening visit to last visit). AEs collection began after the informed consent form had been signed. Each subject was questioned about AEs at each clinical visit following the screening visit. The question 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 each examination or from a laboratory test, observations by the study personnel, subject diaries or spontaneous reports from the subjects.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.9% 2/70 • Number of events 2 • Maximum 32 days for each participant (from screening visit to last visit). AEs collection began after the informed consent form had been signed. Each subject was questioned about AEs at each clinical visit following the screening visit. The question 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 each examination or from a laboratory test, observations by the study personnel, subject diaries or spontaneous reports from the subjects.
Skin and subcutaneous tissue disorders Acne	1.4% 1/70 • Number of events 1 • Maximum 32 days for each participant (from screening visit to last visit). AEs collection began after the informed consent form had been signed. Each subject was questioned about AEs at each clinical visit following the screening visit. The question 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 each examination or from a laboratory test, observations by the study personnel, subject diaries or spontaneous reports from the subjects.
Musculoskeletal and connective tissue disorders Myofascial pain syndrome	1.4% 1/70 • Number of events 1 • Maximum 32 days for each participant (from screening visit to last visit). AEs collection began after the informed consent form had been signed. Each subject was questioned about AEs at each clinical visit following the screening visit. The question 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 each examination or from a laboratory test, observations by the study personnel, subject diaries or spontaneous reports from the subjects.

Additional Information

Reception

Galderma

Phone: +46184749000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place