At a glance
ClinicalIndex Comparison Record- ✓Adult age ≥21 years
- ✓Mild to severe oral commissures or perioral lines (investigator-assessed)
- ✓Willing and able to provide written informed consent
- ✓Able to comply with protocol requirements and photography/video procedures
- ✕Lip filler in past 12 months or neurotoxin injections in past 6 months
- ✕Planned neurotoxin, ablative, cosmetic surgery, or injectable filler treatments during study
- ✕Known allergy or sensitivity to study ingredient components
- ✕History of bleeding disorders
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Assess the Impact of Lip Rejuvenation With Restylane® Silk on Projected First Impressions and Mood Perceptions
In Brief
A clinical study evaluating Restylane® Silk for Lip Rejuvenation. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.