To Evaluate Effectiveness and Safety of GP0109 for Jawline Definition

N/ACompletedNCT05110287

Galderma R&D224 enrolled

Overview

This study is designed to evaluate effectiveness and safety of GP0109 for Jawline definition

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

224

Conditions

Jawline Definition Deficiency

Interventions

GP0109DEVICE

Treatment of the Jawline

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males or non-pregnant, non-breastfeeding females, over the age of 21. Exclusion Criteria: * Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins * Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period.

Locations (1)

Galderma Investigational Site (Site#8784)

San Juan, Puerto Rico

Outcomes

Primary Outcomes

Percentage of Responders Based on Blinded Evaluators' Live Assessment of the Galderma Jawline Scale (GJS)

The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as a participant having at least a 1-grade improvement from baseline on both jawlines concurrently.

Time frame: At Month 3

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.