Safety/Efficacy Study of Restylane® in Lip Augmentation

Medicis Global Service

Status: Completed

Conditions: Lip Augmentation

Treatments: Device: Restylane®; Device: Non-Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT00935272

MA-1300-15

Details and patient eligibility

About

To determine the safety and effectiveness of Restylane® when used for lip augmentation.

Enrollment: 180 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must meet established lip fullness criteria

Exclusion criteria

• Allergic to injectable hyaluronic acid, local topical anesthetics or nerve blocking agents; Conditions/procedures that could interfere with lip fullness evaluations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Treatment

Experimental group

Description:

Restylane® Treatment

Treatment:

Device: Restylane®

Non-Treatment

No Intervention group

Description:

Non-Treatment Arm

Treatment:

Device: Non-Treatment