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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01431755
First received: September 6, 2011
Last updated: June 3, 2013
Last verified: November 2011
  Purpose

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.


Condition Intervention
Facial Tissue Augmentation
Device: Restylane SubQ
Device: Restylane SubQ Lidocaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: A Randomised, Subject-blinded Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride 0.3%

Resource links provided by NLM:


Further study details as provided by Q-Med AB:

Primary Outcome Measures:
  • Pain Relief [ Time Frame: On an average the treatment preference question is completed within 15 minutes after treatment of the cheeks. ] [ Designated as safety issue: No ]
    To evaluate pain relief of added lidocaine to Restylane SubQ by assessing proportion of subjects who assign Restylane SubQ with lidocaine as the least painful treatment in comparison to Restylane SubQ, using a treatment preference question.


Secondary Outcome Measures:
  • Subject Assessment of pain [ Time Frame: Up to 2 hours after injection ] [ Designated as safety issue: No ]
    To evaluate subject assessment of pain during the first 2 hours after injection of Restylane SubQ with and without the addition of lidocaine hydrochloride 0.3%, using a visual analogue scale (VAS).

  • Efficacy in terms of Global Esthetic Improvement Scale (GEIS) score [ Time Frame: 2 weeks, 3, 6, 9 and 12 months after treatment ] [ Designated as safety issue: No ]
    To evaluate the efficacy in terms of GEIS score as assessed by the Investigator and subject, respectively, per treatment group.

  • Efficacy in terms of Medicis Midface Volume Scale (MMVS) [ Time Frame: Screening (day -14 to 0), 2 weeks, 3, 6, 9 and 12 months after treatment ] [ Designated as safety issue: No ]
    To evaluate the efficacy in terms of Medicis Midface Volume Scale (MMVS) as assessed by the Investigator per treatment group.

  • Subject Diary [ Time Frame: Up to two weeks after treatment ] [ Designated as safety issue: Yes ]
    To evaluate the acute safety profile, elicited by subject diary used daily for 2 weeks after injection per treatment group

  • Adverse Events [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    To evaluate safety throughout the study period per treatment group.


Estimated Enrollment: 56
Study Start Date: September 2011
Study Completion Date: October 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Restylane SubQ Device: Restylane SubQ
Treatment with up to 2 ml of the product
Restylane SubQ Lidocaine Device: Restylane SubQ Lidocaine
Treatment with up to 2 ml of the product

Detailed Description:

The Restylane SubQ gel is intended to be used for facial tissue augmentation. The lidocaine content is designed to reduce the subject's pain during treatment. The objectives of this split-face designed study are to evaluate the pain-relieving effect and safety of adding lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained with the dermal filler using the global esthetic improvement scale (GEIS).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 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.

Exclusion Criteria:

  • 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.
  • Participation in any other clinical study within 30 days prior to inclusion.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431755

Locations
Sweden
Akademikliniken
Stockholm, Sweden, 115 42
Plastikkirurggruppen
Stockholm, Sweden, 113 24
ZMedical
Stockholm, Sweden, 114 36
Sponsors and Collaborators
Q-Med AB
Investigators
Principal Investigator: Per Hedén, M.D. Akademikliniken, Storängsvägen 10, 115 42 Stockholm
  More Information

No publications provided

Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01431755     History of Changes
Other Study ID Numbers: 31GE1101
Study First Received: September 6, 2011
Last Updated: June 3, 2013
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 14, 2014