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

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03174132
• Collaborator: (none)
• Enrollment: 70
• Locations: 3
• Arms: 2
• Actual Duration (Months): 3.8
• Patients Per Site: 23.3
• Patients Per Site Per Month: 6.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the pain and safety in associated with injection of Restylane Perlane Lidocaine compared to Restylane Perlane using VAS scale

Condition or Disease	Intervention/Treatment	Phase
Nasolabial Fold	Device: Restylane Perlane Lidocaine; Device: Restylane Perlane	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomised, Multi-center, Subject and Evaluator-blinded Study Comparing the Pain and the Safety Profile Associate With Correction of Moderate to Severe Nasolabial Folds Using Restylane Perlane Lidocaine Compared to Restylane Perlane
• Actual Study Start Date: Sep 21, 2017
• Actual Primary Completion Date: Jan 16, 2018
• Actual Study Completion Date: Jan 16, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Restylane Perlane Lidocaine Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1	Device: Restylane Perlane Lidocaine; Intradermal injection
Active Comparator: Restylane Perlane Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1	Device: Restylane Perlane; Intradermal injection

Outcome Measures

Primary Outcome Measures

1. Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) [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.

Secondary Outcome Measures

1. Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Signed and dated informed consent to participate in the study.

• Men or women aged 20 years or older of Chinese origin.

• Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study.

• Intent to undergo correction of both nasolabial folds (NLF) with a wrinkle severity in Wrinkle Severity Rating Scale (WSRS) of either grade 3 on both NLFs or grade 4 on both NLFs.

Exclusion Criteria:

• Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the lower orbital rim.

• Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months before treatment.

• Previous tissue revitalization treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion in the midface within 6 months before treatment.

• Scars or deformities, active skin disease, inflammation or related conditions near or in the area to be treated.

• Other condition preventing the subject from entering the study in the Investigator's opinion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Medical University	Kaohsiung		Taiwan
2	Chang Gung Memorial Hospital	Taipei		Taiwan
3	Taipei Medical University Hospital	Taipei		Taiwan

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Q-Med AB, Galderma R&D

Study Documents (Full-Text)

• Study Protocol - Apr 13, 2017
• Statistical Analysis Plan - Sep 7, 2017

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT03174132
• Other Study ID Numbers: 43TW1628
• First Posted: Jun 2, 2017
• Last Update Posted: Sep 20, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lidocaine; Hyaluronic Acid

Study Results

Participant Flow

Arm/Group Title	Restylane Perlane Lidocaine and Restylane Perlane
Arm/Group Description	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
Period Title: Overall Study
STARTED	70
COMPLETED	70
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Restylane Perlane Lidocaine and Restylane Perlane
Arm/Group Description	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 Participants	70
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	64 91.4%
>=65 years	6 8.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.2 (10)
Sex: Female, Male (Count of Participants)
Female	60 85.7%
Male	10 14.3%
Race/Ethnicity, Customized (Count of Participants)
Han Chinese	70 100%
Region of Enrollment (participants) [Number]
Taiwan	70 100%

Outcome Measures

1. Primary Outcome

Title	Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS)
Description	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.
Time Frame	At the time of injection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Restylane Perlane Lidocaine and Restylane Perlane
Arm/Group Description	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
Measure Participants	70
Number (95% Confidence Interval) [percentage of subjects]	87.1

2. Secondary Outcome

Title	Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS)
Description	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.
Time Frame	15, 30, 45, and 60 minutes after injection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Restylane Perlane Lidocaine and Restylane Perlane
Arm/Group Description	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
Measure Participants	70
after 15 minutes	64.3
after 30 minutes	42.9
after 45 minutes	31.4
after 60 minutes	24.3

Adverse Events

Time Frame	Maximum 32 days for each participant (from screening visit to last visit).
Adverse Event Reporting Description	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.
Arm/Group Title	Restylane Perlane Lidocaine and Restylane Perlane
Arm/Group Description	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
All Cause Mortality
	Restylane Perlane Lidocaine and Restylane Perlane
	Affected / at Risk (%)	# Events
Total	0/70 (0%)
Serious Adverse Events
	Restylane Perlane Lidocaine and Restylane Perlane
	Affected / at Risk (%)	# Events
Total	0/70 (0%)
Other (Not Including Serious) Adverse Events
	Restylane Perlane Lidocaine and Restylane Perlane
	Affected / at Risk (%)	# Events
Total	7/70 (10%)
Infections and infestations
Oral herpes	1/70 (1.4%)	1
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome	1/70 (1.4%)	1
Nervous system disorders
Presyncope	1/70 (1.4%)	1
Headache	1/70 (1.4%)	1
Respiratory, thoracic and mediastinal disorders
Cough	1/70 (1.4%)	1
Oropharyngeal pain	2/70 (2.9%)	2
Skin and subcutaneous tissue disorders
Acne	1/70 (1.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.