NCT05691972
Completed
Not Applicable
A Randomized, No-treatment-controlled, Evaluator-blinded, Multi-center Study to Evaluate the Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing
ConditionsTemporal Hollowing
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Temporal Hollowing
- Sponsor
- Galderma R&D
- Enrollment
- 225
- Locations
- 1
- Primary Endpoint
- Responder rate based on the Blinded Evaluators' live assessment of the GTVDS
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane® Contour in correction of temple hollowing.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males or non-pregnant, non-breastfeeding females, 22 years of age or older
- •Intent to undergo treatment for correction of temple hollowing
Exclusion Criteria
- •Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins
- •Known/previous allergy or hypersensitivity to local anesthetics, e.g., lidocaine or other amide-type anesthetics or nerve blocking agents (if intended to be used for that subject)
- •Previous facial surgery (e.g., facelift) above the level of the horizontal line from subnasale that in the Treating Investigator´s opinion could interfere with the study safety and/or effectiveness assessments
- •Any previous aesthetic procedures or implants
- •Recurrent temporal headaches such as temporal tendinitis migraine. Have a history of migraines or frequent headaches, as determined by the (Treating) Investigator, that could interfere with the study safety and/or effectiveness assessments
Outcomes
Primary Outcomes
Responder rate based on the Blinded Evaluators' live assessment of the GTVDS
Time Frame: Baseline to 3 months
Secondary Outcomes
- Responder rates, as assessed by the Blinded Evaluator at 6, 9 and 12 months after baseline for the treatment group(6,9,12 months after baseline)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Restylane Perlane Lidocaine for Correction of Midface Volume Deficit and/or Midface Contour DeficiencyMidface Volume DeficitNCT03097783Galderma R&D169
Recruiting
Not Applicable
Evaluate the Effectiveness and Safety of Restylane Volyme in the Treatment of Temple HollowingNCT06665477Galderma R&D162
Completed
Not Applicable
Main Study: A Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area Sub-study: A Follow-up Study to Evaluate the Analysis of Mammograms Following Treatment for Correction of Wrinkles in Décolletage Area in the Investigational Study 43USRV1906WrinkleNCT04717934Galderma R&D211
Recruiting
Not Applicable
TEOSYAL RHA® 1 for the Correction of Moderate to Severe Tissue Volume Deficiency in the Infraorbital Region in Chinese AdultsInfraorbital HollowsNCT06749587Teoxane SA260
Recruiting
Phase 1
NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot UlcersDiabetic Foot UlcerNCT06402565NOxy Health Products, LLC40