A Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride

NCT01431755 | Completed Results

• 1 other identifier: 31GE1101
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

Brief Summary

The objectives of this study are to evaluate the pain-relieving effect and safety of adding lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained. The study products will be administered in the cheek.

Conditions

Facial Tissue Augmentation

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful.

  When injection of both cheeks was completed, the subject was asked which treatment was least painful (right cheek/left cheek/both cheeks alike).

  When injection of both cheeks were completed

Secondary Outcomes (5)

• Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment.

  15 and 120 minutes

• Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS)

  2 weeks

• Percentage of Subjects With at Least One Step Improvement on Medicis Midface Volume Scale (MMVS) at 2 Weeks

  2 weeks

• Number of Subjects Reporting at Least 1 Diary Complaint Related to the Cheek Treated With Restylane SubQ and Restylane SubQ Lidocaine Respectively After Initial Treatment.

  14 days

• Number of Subjects Reporting Adverse Event

  Up to 12 months

Study Arms (2)

Restylane SubQ

OTHER

Device: Restylane SubQ

Restylane SubQ Lidocaine

OTHER

Device: Restylane SubQ Lidocaine

Interventions

Restylane SubQ DEVICE

Treatment with up to 2 ml of the product

Restylane SubQ

Restylane SubQ Lidocaine DEVICE

Treatment with up to 2 ml of the product

Restylane SubQ Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older.
• Intent to undergo contouring of both cheeks with 1.5 to 2 ml Restylane SubQ per cheek.
• Sufficient symmetry of the face in order to ensure similar volume to be injected, similar injection technique and time for injection.
• Signed informed consent.

You may not qualify if:

• Surgery in the midface including aesthetic facial surgical therapy, sinus surgery or dental root surgery within the past 12 months.
• Chronic infection in head and neck region.
• Ongoing infections in mouth.
• Tendency for edema, puffiness or swelling over the zygomatic prominence.
• Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the area to be treated.
• Previous hypersensitivity to hyaluronic acid or local anesthetics.
• Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation within 10 days prior to treatment, or a history of bleeding disorders.
• Cancerous or pre-cancerous lesions in the area to be treated.
• Previous tissue augmenting therapy in the area to be treated with non-permanent filler, laser treatment, or chemical peeling during the last 6 months.
• Permanent implant placed in the area to be treated.
• Reduced sensibility in the facial region e.g. due to trauma, facial pareses, previous tissue augmenting therapy, aesthetic facial surgical therapy, laser treatment, or peeling.
• Pregnancy or breast feeding.
• Other condition preventing the subject to entering the study in the Investigator's opinion e.g. subjects not likely to avoid other facial cosmetic treatments below the level of the upper orbital rim, subjects anticipated to be unreliable or incapable of understanding the VAS assessment, insufficient tissue support or cover of the treatment area.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (3)

Plastikkirurggruppen

Stockholm, 113 24, Sweden

Location

ZMedical

Stockholm, 114 36, Sweden

Location

Akademikliniken

Stockholm, 115 42, Sweden

Location

Results Point of Contact

• Title: Head of Medical Affairs
• Organization: Q-Med AB

reception.SEUPP@galderma.com

+46 (0) 18 474 90 00

Study Officials

• Per Hedén, M.D.

  Akademikliniken, Storängsvägen 10, 115 42 Stockholm

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: September 12, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2012
• Last Updated: September 22, 2022
• Results First Posted: April 23, 2014

Record last verified: 2014-04

Locations

SE (3)