Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root
A Randomized, Open Label, No-treatment Controlled, Multi-center, Efficacy and Safety Study Using Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root
1 other identifier
interventional
132
1 country
2
Brief Summary
The purpose of this study is to determine the safety and efficacy of using Restylane Perlane to shape the nasal dorsum and/or nasal root in comparison with a no-treatment control group
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2014
CompletedFirst Posted
Study publicly available on registry
August 15, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
September 23, 2021
CompletedAugust 26, 2022
September 1, 2021
1.2 years
August 13, 2014
July 5, 2021
August 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control
The primary objective of the study was to evaluate the efficacy of Restylane Perlane in shaping the nasal dorsum and/or nasal root as compared to no-treatment control, by assessment of the primary endpoint:The change in volume will be measured using 3 D photography technique. The change in volume was calculated as the value at 6 months of treatment group compared with non-treatment group
6 months
Study Arms (2)
Restylane Perlane
EXPERIMENTALSingle injection of Restylane Perlane in nasal dorsum and/or nasal root
No-treatment control
NO INTERVENTIONNo-treatment control group do not receive any treatment during the main study period
Interventions
Eligibility Criteria
You may qualify if:
- Chinese origin
- Subject with desire to shape the nasal dorsum and/or nasal root
- Subjects who, in the opinion of the investigator, can achieve a clinically meaningful aesthetic correction of their nose with ≤ 1 ml Restylane Perlane
You may not qualify if:
- Subjects with previous nasal surgery, including grafts or implants to the nose area
- Subjects requiring filler treatment around the tip of the nose or between the eyebrows (glabella region) to achieve a good aesthetic outcome
- Subjects with a history of chronic sinusitis or rhinitis
- Subjects who have previously received aesthetic treatment in the forehead, glabellar and/or nose area with a dermal filler
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (2)
Unknown Facility
Beijing, China
Unknown Facility
Guangzhou, China
Results Point of Contact
- Title
- Head of Development
- Organization
- Q-Med AB
Study Officials
- STUDY DIRECTOR
Q-Med AB
Galderma R&D
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2014
First Posted
August 15, 2014
Study Start
September 1, 2014
Primary Completion
December 1, 2015
Study Completion
June 1, 2016
Last Updated
August 26, 2022
Results First Posted
September 23, 2021
Record last verified: 2021-09