DeNova Research
Chicago, Illinois, 60611, United States
NCT Number: NCT03241862
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.
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Notify Me21 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60611, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 month
The projected first impressions are assessed by blinded evaluators using photographs.
The projected first impressions are assessed by blinded evaluators using the First Impression Questionnaire (FIQ).
Each of the below First Impression Questionnaire (FIQ) categories is scored between 1 (disagree)-10 (agree) and a total of 8 categories (see below) are assessed for a total possible score of 80. All scores will be graded out of a total possible score of 80 points Social skills Academic Performance Dating Success Occupational success Attractiveness Financial Success Relationship success Athletic success Total scores closer to 80 indicate a more favorable outcome.
Time frame: Visit 1 at Baseline and Visit 3 (Week 4) or Visit 4 (Week 6)
Changes in the appearance of the lip and the perioral area are assessed by the PI using the Oral Commissure Severity Scale (OCSS) at Visit 1 and Visit 3/4
Oral Commissure Severity Scale (OCSS): graded from None (0), Mild (1), Moderate (2), Severe (3)
None: No wrinkle or fold; slight upturned commissures Mild: Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners Moderate: Moderately deep and/or long wrinkle or crease; downturned corners Severe: Very deep and/or long wrinkle or crease; frown at rest
DeNova Research
Other
Assess the Impact of Lip Rejuvenation With Restylane® Silk on Projected First Impressions and Mood Perceptions
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.