NCT03241862

Assess the Impact of Lip Rejuvenation on Projected First Impressions and Mood Perceptions

Assess the Impact of Lip Rejuvenation With Restylane® Silk on Projected First Impressions and Mood Perceptions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: DeNova Research · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

20 subjects with mild to severe oral commissures or none to severe perioral lines will be enrolled and injected with Restylane® Silk. Photographs will be taken prior to and 14 days after Optimal Cosmetic Results has been achieved, as judged by the investigator. Changes in the projected first impression will be assessed by a total of 200 blinded evaluators rating the photographs of subjects from the baseline and from 14 days post achieving the Optimal Cosmetic Results. Changes in subjects' mood will be self-assessed through Subjective Happiness Scale and Happiness Measures questionnaires. Aesthetic alterations will be assessed by the investigator via the Global Aesthetic Improvement Scale, Oral Commissure Severity Scale, and the Perioral Lines Severity Scale as well as by the self-assessment of subjects using the Global Aesthetic Improvement Scale.

Conditions

• Lip Rejuvenation

Interventions

Type	Name	Description
DEVICE	Restylane® Silk	Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids.

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-06-01
• Completion: 2017-06-16
• First posted: 2017-08-08
• Last updated: 2020-11-04
• Results posted: 2020-11-04

Locations

1 site across 1 country: United States