Trial Outcomes & Findings for Pain and Safety of Restylane With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds (NCT NCT02918721)

Last Updated: 2023-06-01

Results Overview

Subjects that reported at least 10 mm less VAS pain associated with injections of Restylane-Lido compared to Restylane 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

Target enrollment

70 participants

Primary outcome timeframe

Up to 60 minutes after Injection on Day of Treatment

Results posted on

2023-06-01

Participant Flow

Total 70 subjects enrolled and each subject has 2 NLFs, in total 70 NLFs were injected with Rstylane, opposite 70 NLFs was Restylane Lido.

Participant milestones

Participant milestones
Measure	All Study Participants Restylane Lidocaine will be injected into one side of the nasolabial fold at day 1 Restylane Lidocaine: Intradermal injection Restylane will be injected into the opposite side of the nasolabial fold on day 1 Restylane: 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 With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=70 Participants Restylane Lidocaine will be injected into one side of the nasolabial fold at day 1 Restylane Lidocaine: Intradermal injection Restylane will be injected into the opposite side of the nasolabial fold on day 1 Restylane: Intradermal injection
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	68 Participants n=5 Participants
Age, Continuous	44 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race/Ethnicity, Customized Han Chinese	70 Participants n=5 Participants
Region of Enrollment China	70 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 60 minutes after Injection on Day of Treatment

Outcome measures

Outcome measures
Measure	All Study Participants n=70 Participants Restylane Lidocaine will be injected into one side nasolabial fold on Day 1 Restylane Lidocaine: Intradermal injection Restylane will be injected into opp side nasolabial fold on Day 1 Restylane: Intradermal injection
Treatment Difference in Pain (Restylane Lidocaine Side - Restylane Side) as Measured by a Visual Analogue Scale(VAS)	77.1 percentage of subjects Interval 65.6 to 86.3

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 Restylane-Lido compared to Restylane 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 rig

Outcome measures

Outcome measures
Measure	All Study Participants n=70 Participants Restylane Lidocaine will be injected into one side nasolabial fold on Day 1 Restylane Lidocaine: Intradermal injection Restylane will be injected into opp side nasolabial fold on Day 1 Restylane: Intradermal injection
Treatment Differences in Pain (Restylane Side - Restylane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) after 15 minutes	55.7 percentage of subjects Interval 43.3 to 67.6
Treatment Differences in Pain (Restylane Side - Restylane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) after 30 minutes	48.6 percentage of subjects Interval 36.4 to 60.8
Treatment Differences in Pain (Restylane Side - Restylane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) after 45 minutes	35.7 percentage of subjects Interval 24.6 to 48.1
Treatment Differences in Pain (Restylane Side - Restylane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) after 60 minutes	31.4 percentage of subjects Interval 20.9 to 43.6

Adverse Events

All Study Participants

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Study Participants n=70 participants at risk Restylane Lidocaine will be injected into one side nasolabial fold on Day 1 Restylane Lidocaine: Intradermal injection Restylane will be injected into one side nasolabial fold on Day 1 Restylane: Intradermal injection
Gastrointestinal disorders Pyrexia	1.4% 1/70 • Number of events 1 • Up to 2 weeks Each subject was asked about AEs at each clinical 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.
Immune system disorders Food allergy	1.4% 1/70 • Number of events 1 • Up to 2 weeks Each subject was asked about AEs at each clinical 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 Nasopharyngitis	1.4% 1/70 • Number of events 1 • Up to 2 weeks Each subject was asked about AEs at each clinical 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.
Immune system disorders Upper respiratory tract infection	1.4% 1/70 • Number of events 1 • Up to 2 weeks Each subject was asked about AEs at each clinical 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.
Injury, poisoning and procedural complications Contusion	1.4% 1/70 • Number of events 1 • Up to 2 weeks Each subject was asked about AEs at each clinical 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.
Investigations Alanine aminotransferase increased	1.4% 1/70 • Number of events 1 • Up to 2 weeks Each subject was asked about AEs at each clinical 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.
Investigations Blood uric acid increased	1.4% 1/70 • Number of events 1 • Up to 2 weeks Each subject was asked about AEs at each clinical 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.
Investigations Transaminases abnormal	1.4% 1/70 • Number of events 1 • Up to 2 weeks Each subject was asked about AEs at each clinical 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

Head of Development

Q-Med AB

Phone: +46184749000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place