A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds
A Randomized, Controlled, Evaluator-blinded, Split Face Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds
1 other identifier
interventional
20
1 country
1
Brief Summary
This is a study to assess the performance and safety of GP0045 when injected in the nasolabial folds. There is an 18 months follow up period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
1 active site
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
September 28, 2017
CompletedStudy Start
First participant enrolled
October 2, 2017
CompletedFirst Posted
Study publicly available on registry
October 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2019
CompletedResults Posted
Study results publicly available
April 17, 2020
CompletedAugust 26, 2022
April 1, 2020
7 months
September 28, 2017
March 17, 2020
August 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale
The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator.
6 months
Secondary Outcomes (1)
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale
2 weeks, 3, 9, 12, 15 and 18 months
Study Arms (2)
GP0045
EXPERIMENTALTreatment with GP0045
Comparator
ACTIVE COMPARATORTreatment with active comparator
Interventions
Eligibility Criteria
You may qualify if:
- Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability to give consent to participate in the study
- Signed and dated informed consent to participate in the study, including photo consent
- Subjects with intent to undergo correction of both nasolabial folds
You may not qualify if:
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel
- Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics
- Participation in any other clinical study with an investigational product within 30 days before treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (1)
Q-Med
Uppsala, Sweden
Results Point of Contact
- Title
- Clinical Project Manager
- 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
September 28, 2017
First Posted
October 3, 2017
Study Start
October 2, 2017
Primary Completion
April 27, 2018
Study Completion
April 24, 2019
Last Updated
August 26, 2022
Results First Posted
April 17, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share