Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root

Galderma

Status: Completed

Conditions: Nasal Augmentation

Treatments: Device: Restylane Perlane

Study type: Interventional

Funder types: Industry

Identifiers

NCT02216851

43CH1310

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of using Restylane Perlane to shape the nasal dorsum and/or nasal root in comparison with a no-treatment control group

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chinese origin
• Subject with desire to shape the nasal dorsum and/or nasal root
• Subjects who, in the opinion of the investigator, can achieve a clinically meaningful aesthetic correction of their nose with ≤ 1 ml Restylane Perlane

Exclusion criteria

• Subjects with previous nasal surgery, including grafts or implants to the nose area
• Subjects requiring filler treatment around the tip of the nose or between the eyebrows (glabella region) to achieve a good aesthetic outcome
• Subjects with a history of chronic sinusitis or rhinitis
• Subjects who have previously received aesthetic treatment in the forehead, glabellar and/or nose area with a dermal filler

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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132 participants in 2 patient groups

Restylane Perlane

Experimental group

Description:

Single injection of Restylane Perlane in nasal dorsum and/or nasal root

Treatment:

Device: Restylane Perlane

No-treatment control

No Intervention group

Description:

No-treatment control group do not receive any treatment during the main study period