Efficacy and Safety of Perlane-L in the Correction of Midface Volume Deficit

Medicis Global Service

Status: Unknown

Conditions: Facial Volume

Treatments: Other: Non-treatment; Device: Perlane-L

Study type: Interventional

Funder types: Industry

Identifiers

NCT01565915

MA-1400-05

Details and patient eligibility

About

The purpose of this study is to determine if Perlane-L is safe in increasing cheek volume.

Enrollment: 221 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Loss of Fullness in Midface Area
• Other items as identified in the protocol

Exclusion criteria

• History of allergy or hypersensitivity to injectable hyaluronic acid gel or lidocaine.
• Other items as identified in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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221 participants in 2 patient groups

Perlane-L

Experimental group

Description:

Perlane-L treatment

Treatment:

Device: Perlane-L

Non-Treatment

Sham Comparator group

Description:

Non-Treatment Arm

Treatment:

Other: Non-treatment