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N/A N=60 Treatment

Study to Evaluate Efficacy, Safety and Injection Technique of Restylane Lip Volume and Restylane Lip Refresh

Injection Techniques

Enrolled (actual)
60
Serious AEs
5.0%
Results posted
Oct 2018
Primary outcome: Primary: GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment — 86.2; 86.7 percentage improved subjects

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Restylane Lip Volume (Device); Restylane Lip Refresh (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Galderma R&D
Primary completion
Nov 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment
86.2; 86.7
SECONDARY
GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 36 After Treatment
93.1; 78.6
SECONDARY
GEIS (Global Esthetic Improvement Scale) Assessed by the Treating Investigator at Week 36 After Treatment
82.8; 82.8
SECONDARY
GEIS (Global Esthetic Improvement Scale) Assessed by the Independent Evaluator at Week 36 After Treatment
86.2; 86.2
SECONDARY
MLFS (Medicis Lip Fullness Scale) at Week 8
50.0
SECONDARY
Subject Satisfaction Questionnaire
93; 87
SECONDARY
Subject Diary for 14 Days After Initial Treatment
2; 6

Summary

The purpose of this study is to demonstrate the efficacy and safety of two new Restylane Lip products, Restylane Lip Volume and Restylane Lip Refresh, and to collect information on the injection technique.

Eligibility Criteria

Inclusion Criteria

  • 18 to 60 years of age.
  • Intent to undergo lip augmentation or rejuvenation of both the upper and lower lip.
  • Signed informed consent.

Exclusion Criteria

  • Prior surgery or tattoo to the upper or lower lip or lip line.
  • Presence of any abnormal lip structure, such as a scar or lump or severe lip asymmetry.
  • A history of herpes labialis and an outbreak within four weeks of study entry or with four or more outbreaks in the 12 months prior to study entry.
  • Presence of facial hair that may interfere with efficacy evaluations.
  • Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the area to be treated.
  • History of angioedema.
  • 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 hyaluronic acid (HA) or collagen filler, or laser treatment, during the last 12 months.
  • Permanent implant placed in the area to be treated or treatment with non-HA or non-collagen filler in the area to be treated.
  • 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 lower orbital rim, subjects anticipated to be unreliable or incapable of understanding the study assessment or unrealistic expectations of treatment result.
  • Study staff or close relative to study staff (e.g. parents, children, siblings or spouse).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01428024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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