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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-21

Study Completion Date

2018-01-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02918721

Nasolabial Fold

COMPLETED NA

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

NCT02565784

Healthy Volunteers

COMPLETED NA

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

NCT02432742

Nasolabial Folds in Chinese Population

COMPLETED NA

A Post Market Evaluation After Treatment of Nasolabial Folds

NCT02179736

Nasolabial Folds

COMPLETED NA

Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds

NCT06305520

Nasal Disease Nasal Surgery

ENROLLING_BY_INVITATION NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nasolabial Fold

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Restylane Perlane Lidocaine

Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1

Group Type EXPERIMENTAL

Restylane Perlane Lidocaine

Intervention Type DEVICE

Intradermal injection

Restylane Perlane

Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1

Group Type ACTIVE_COMPARATOR

Restylane Perlane

Intervention Type DEVICE

Intradermal injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Restylane Perlane Lidocaine

Intradermal injection

Intervention Type DEVICE

Restylane Perlane

Intradermal injection

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No