Brief Summary

A multi-centre, evaluator-blinded study in subjects undergoing cheek augmentation. The study is designed to assess efficacy with regard to aesthetic midface augmentation and safety after treatment with HA product.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach

1 country

2 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

First Submitted

Initial submission to the registry

February 27, 2015

Completed

1 day until next milestone

Study Start

First participant enrolled

February 28, 2015

Completed

24 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2016

Completed

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2017

Completed

1.9 years until next milestone

Results Posted

Study results publicly available

October 1, 2019

Completed

Last Updated

August 26, 2022

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

February 27, 2015

Results QC Date

June 12, 2019

Last Update Submit

August 24, 2022

Conditions

Facial Tissue Augmentation

Outcome Measures

Primary Outcomes (1)

Percentage of Responders in Midface Fullness Using Photo Scale
Evaluation of midface fullness, determined by the percentage of responders at 3 months after last treatment, in both cheeks, derived from the Blinded Evaluator's live assessment of a validated photo scale. A responder was defined as a subject with ≥1 grade improvement from baseline in both cheeks.
3 months

Secondary Outcomes (1)

Percentage of Responders in Midface Fullness Using Photo Scale
15 months

Study Arms (2)

HA experimental

EXPERIMENTAL

HA experimental only

Device: HA experimental

HA comparator

ACTIVE COMPARATOR

HA experimental + HA comparator

Device: HA experimentalDevice: HA comparator

Interventions

HA experimentalDEVICE

HA comparatorHA experimental

HA comparatorDEVICE

HA comparator

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Provide a signed and dated informed consent to participate in the study including release of copyright of images
Man or woman aged 18 years or older
Be willing to abstain from any other facial plastic surgical or cosmetic procedures in close proximity to the treated area

You may not qualify if:

Known/previous allergy or hypersensitivity to any injectable HA gel
History of bleeding disorder or treatment with anticoagulants, thrombolytics, or inhibitors of platelet aggregation, omega-3, or vitamin E within 2 weeks before treatment
Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy, topical retinoids, systemic or topical corticosteroids within 3 months before treatment and systemic retinoids within 6 months before treatment
Previous tissue augmenting therapy or contouring with permanent filler, fat-injection or permanent implant placed in the area to be treated
The subject is, in the opinion of the investigator, unlikely to comply with the clinical investigational plan or is unsuitable for any other reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Galderma R&Dlead

Study Sites (2)

Unknown Facility

Gothenburg, Sweden

Location

Unknown Facility

Stockholm, Sweden

Location

Results Point of Contact

Title: Reception
Organization: Galderma

Study Officials

Q-Med AB
Galderma R&D
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 27, 2015

First Posted

March 24, 2015

Study Start

February 28, 2015

Primary Completion

December 19, 2016

Study Completion

November 14, 2017

Last Updated

August 26, 2022

Results First Posted

October 1, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing: Will not share

Locations

SE(2)

Study Stopped

Evaluation of Efficacy and Safety of Hyaluronic Acid (HA) Product for Cheek Augmentation

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

HA experimental

HA comparator

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

HA experimental

HA comparator

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations