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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: April 23, 2014
Last verified: April 2014

September 6, 2011
April 23, 2014
September 2011
October 2011   (final data collection date for primary outcome measure)
Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful. [ Time Frame: When injection of both cheeks were completed ] [ Designated as safety issue: No ]
When injection of both cheeks was completed, the subject was asked which treatment was least painful (right cheek/left cheek/both cheeks alike).
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.
Complete list of historical versions of study NCT01431755 on ClinicalTrials.gov Archive Site
  • Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment. [ Time Frame: 15 and 120 minutes ] [ Designated as safety issue: No ]
    Pain was assessed during the first 2 hours after the initial injection of the study products using a 100 mm VAS. The endpoints of the scale were "no pain" (0 mm) and "worst possible pain" (100 mm). Pain was assessed at the time points 15, 30, 60, 90 and 120 minutes after injection.
  • Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Esthetic improvement was evaluated by using Global Esthetic Improvement Scale. GEIS was evaluated by comparing current photos with pre-treatment photos and using a 5-graded scale (worse/no change/somewhat improved/much improved/very much improved). A clinically significant global esthetic improvement was defined as a score of somewhat improved, much improved or very much improved. GEIS was assessed by the Investigator and the subject. Each cheek/study product was evaluated separately. GEIS was assessed at the time points 2 weeks, 3 months, 2 weeks after re-treatment and 6, 9 and 12 months after first treatment.
  • Percentage of Subjects With at Least One Step Improvement on Medicis Midface Volume Scale (MMVS) at 2 Weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The severity of midface volume loss or midface contour deficiency was assessed by the investigators using a 4-graded scale, Medicis Midface Volume Scale -MMVS (1, fairly full; 2, mild loss of fullness; 3, moderate loss, slight hollowing; and 4, substantial loss, clearly apparent hollowing). Each score were exemplified by photographic images on the scale. A one grade decrease in score from screening was defined as a treatment success/improvement.The efficacy in terms of Medicis Midface Volume Scale (MMVS) was assessed by the Investigator per treatment group. The two cheeks were evaluated separately. MMVS was assessed at the time points 2 weeks, 3 months, 2 weeks after re-treatment and 6, 9 and 12 months after first treatment.
  • 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. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    A subject diary was completed for 14 days following the initial treatment and the optional re-treatment at the 3-month visit. Each subject was asked to record the presence of bruising, redness, swelling, pain, tenderness and itching.
  • Number of Subjects Reporting Adverse Event [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

    Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.

    All subjects were injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek.

  • 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.
  • Acute safety profile [ 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 and adverse events collected from the subject and by Investigator assessment of findings at day of treatment, and at 2-week-visit, per treatment group.
  • Long-term safety profile [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    To evaluate safety throughout the study period per treatment group.
  • Placement of gel [ Time Frame: 2 weeks and 3 months ] [ Designated as safety issue: No ]
    To evaluate in a subpopulation of the subjects, by ultrasound, the placement of the gel using the sharp needle and blunt microcannula, respectively.
Not Provided
Not Provided
 
A Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride
A Randomised, Subject-blinded Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride 0.3%

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Facial Tissue Augmentation
  • Device: Restylane SubQ
    Treatment with up to 2 ml of the product
  • Device: Restylane SubQ Lidocaine
    Treatment with up to 2 ml of the product
  • Restylane SubQ
    Intervention: Device: Restylane SubQ
  • Restylane SubQ Lidocaine
    Intervention: Device: Restylane SubQ Lidocaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
October 2012
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01431755
31GE1101
Not Provided
Q-Med AB
Q-Med AB
Not Provided
Principal Investigator: Per Hedén, M.D. Akademikliniken, Storängsvägen 10, 115 42 Stockholm
Q-Med AB
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP