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

NCT01428024 | Completed Results

• 1 other identifier: 31GE1102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Injection Techniques

Keywords

efficacy; safety; Restylane; Lip products; injection techniques

Outcome Measures

Primary Outcomes (1)

• GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment

  To evaluate esthetic change of lips from baseline as judged by the subjects using GEIS. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change, worse.

  At week 8 - change of lips from baseline

Secondary Outcomes (6)

• GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 36 After Treatment

  week 36 - change from baseline

• GEIS (Global Esthetic Improvement Scale) Assessed by the Treating Investigator at Week 36 After Treatment

  week 36 - change from baseline

• GEIS (Global Esthetic Improvement Scale) Assessed by the Independent Evaluator at Week 36 After Treatment

  week 36 - change from baseline

• MLFS (Medicis Lip Fullness Scale) at Week 8

  week 8 - change from baseline

• Subject Satisfaction Questionnaire

  Week 8

Study Arms (2)

Restylane Lip Volume

EXPERIMENTAL

Submucosal injections with Restylane Lip Volume. Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 2 and 12.

Device: Restylane Lip Volume

Restylane Lip Refresh

EXPERIMENTAL

Submucosal injections with Restylane Lip Refresh. Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 2 and 12.

Device: Restylane Lip Refresh

Interventions

Restylane Lip Volume DEVICE

Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.

Restylane Lip Volume

Restylane Lip Refresh DEVICE

Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.

Restylane Lip Refresh

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (3)

Göteborgs Plastikkirurgiska Center

Gothenburg, 412 65, Sweden

Location

Stureplanskliniken

Stockholm, 111 44, 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 4749000

Study Officials

• Ulf Samuelsson, Med Dr

  Akademikliniken, Storängsvägen 10, 115 42 Stockholm

  PRINCIPAL INVESTIGATOR

• Dan Fagrell, Med Dr

  Göteborgs Plastikirurgiska Center, Fridkullagatan 35 412 65 Göteborg

  PRINCIPAL INVESTIGATOR

• Pyra Haglund, Med Dr

  Stureplanskliniken, Lästmakargatan 10, 111 44 Stockholm

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 2, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: June 1, 2012
• Last Updated: August 26, 2022
• Results First Posted: October 18, 2018

Record last verified: 2013-11

Locations

SE (3)