Lip Rejuvenation
Conditions
Brief 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.
Interventions
DEVICERestylane® 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.
Sponsors
DeNova Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject is an adult of at least 21 years of age; * Subject has mild to severe oral commissures or none to severe perioral lines, as assessed by the treating investigator; * Subject is willing and able to provide written informed consent prior to the performance of any study related procedure; * Subject is willing and able to comply with the protocol requirements; and * Subject is willing and able to provide written photo consent and adhere to the photography and video procedures such as removal of jewelry and makeup
Exclusion criteria
* Subjects who have received lip filler treatments in the past 12 months or neurotoxin injections in the past 6 months; * Subjects who plan to undergo neurotoxin treatments, ablative skin treatments, facial cosmetic surgery, or other injectable filler treatments during the course of the study; * Subjects with a known allergy or sensitivity to any component of the study ingredients; * Subjects with a history of bleeding disorders; * Female subjects who are pregnant or nursing as well as those who are of childbearing potential but do not employ adequate birth control methods; * Subjects with severe allergies manifested by a history of anaphylaxis or presence of multiple severe allergies; * Subjects with previous history of sensitivity to amide type local anesthetics; * Current history of chronic drug or alcohol abuse; * Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study product; * Subjects who, in the investigator's opinion, have a history of poor cooperation, non-compliance with medical treatment, or unreliability; and * Enrollment in any active study involving the use of investigational devices or drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Impressions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Appearance of the Lip and Perioral Area | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restylane® Silk All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk.
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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Restylane® Silk |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 53 years STANDARD_DEVIATION 0 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
First Impressions
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: 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restylane® Silk | First Impressions | Academic Performance | 27.769 score on a scale | Standard Deviation 0.887 |
| Restylane® Silk | First Impressions | Dating success | 46.391 score on a scale | Standard Deviation 0.648 |
| Restylane® Silk | First Impressions | Occupational success | 34.404 score on a scale | Standard Deviation 0.555 |
| Restylane® Silk | First Impressions | Attractiveness | 49.612 score on a scale | Standard Deviation 0.544 |
| Restylane® Silk | First Impressions | Financial success | 25.029 score on a scale | Standard Deviation 0.758 |
| Restylane® Silk | First Impressions | Relationship success | 34.245 score on a scale | Standard Deviation 0.931 |
| Restylane® Silk | First Impressions | Athletic success | 45.433 score on a scale | Standard Deviation 0.835 |
| Restylane® Silk | First Impressions | Social skills | 46.756 score on a scale | Standard Deviation 0.052 |
Secondary
Appearance of the Lip and Perioral Area
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
Time frame: Visit 1 at Baseline and Visit 3 (Week 4) or Visit 4 (Week 6)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restylane® Silk | Appearance of the Lip and Perioral Area | Visit 1 | 2.39 units on a scale | Standard Deviation 0.502 |
| Restylane® Silk | Appearance of the Lip and Perioral Area | Visit 3/4 | 0.71 units on a scale | Standard Deviation 0.47 |