Lip, Lip Aging, Lip Augmentation
Conditions
Brief summary
This study aims to learn more about the effects of aging and lip filler treatment on lips and the surrounding skin by comparing, among two different age groups of people, changes in the blood vessels and nerves, volume, color and texture change before and after lip filler treatment and pain tolerance from lip filler treatment.
Detailed description
This study will investigate aging of the cutaneous changes of human skin anatomy in the lips and perioral area to better understand and quantify the aging process in this, including the effect of age on lip redness. Additionally, the investigators aim to test the effects of a common lip augmentation procedure, hyaluronic-acid based fillers, on the appearance (volume, texture and color) of aging lips, in addition to the tolerability of this procedure. It is hypothesized that dermal lip fillers may decrease the redness of the lips. Besides, the investigators want to evaluate oxytocin level changes and relate it to subjects' satisfaction after the lip filler procedure.
Interventions
Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
Sponsors
Dieter Manstein, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Standard photographs will be blindly reviewed by a physician.
Intervention model description
Investigators will enroll 40 subjects; 20 subjects who are 21-30 years old and 20 subjects who are post-menopausal women. Both groups will receive identical treatments.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be able and willing to provide written informed consent and comply with the requirements of the study protocol; * In good general health, based on answers provided during the screening visit; * Subjects must be able to read and understand English; * Caucasian female; * Aged 21-30 years and post-menopausal; * Skin Types (all Fitzpatrick Skin Phototypes ); * Smoking history is self-report. * Have very thin to moderately thick lips (Lip Fullness Grading Scale \[LFGS\] scores 0-2).
Exclusion criteria
* Participation in another investigational drug or device clinical trial in the past 30 days; * Are pregnant or lactating; * Intake of hormone replacement therapy (HRT) in the past 6 months; * Have a history of drug or alcohol abuse or have reported habitual alcohol intake greater than 2 standard drinks per day \[e.g., 2 beers, 2 glasses of wine, or 2 mixed drinks\]; * Presence of eczema, psoriasis, or any other skin disease on the lips or perioral skin; * Have birth marks, tattoos, scars, or any other disfiguration of the skin in the skin area of interest; * Use of any anti-aging skin care products containing retinoic acid, retinol, or other retinoids (e.g. tazarotene, adapalene) or estrogen on the skin area of interest in the past 6 months; * Use of any prescription topical medication, such as corticosteroids or hydroquinone on the skin area of interest in the past 6 months; * Have a history of photodynamic therapy treatment or any skin rejuvenation procedure on the skin area of interest; * History of blood-clotting abnormality; * History of keloid formation or hypertrophic scarring; * Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study; * Exhibits any clinical conditions or takes any medication which in the opinion of the investigator may interfere with the study or pose a risk to subject safety during the study; * Is not able to follow study protocol; * Have permanent lip implant, and lip enhancement or laser therapy performed within the preceding 12 months; * Known history of allergy or sensitivity to glycerol, Tegaderm, lidocaine, hyaluronic acid dermal fillers or materials with gram-positive bacterial proteins.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lip Vessel's Thickness | Day 1 and Day 14 | Pre and post-treatment lip vessel thickness was measured in µm using Optical Coherence Tomography-Angiography imaging. For each age group, pre and post-treatment means were calculated. The difference between the post and the pre-treatment means is shown below (post-treatment mean - pre-treatment mean). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wong-Baker FACES Pain Rating Scale | Day 1 | This scale will be used to record the subject's overall pain from the procedure. There are 6 faces ranging from 0=no pain to 10=the worst pain. |
| Lip Fullness Measurement (Measures the Increase of Lip's Size After the Procedure) | D1 and D14 | The Lip Fullness Grading Scale was used to measure the size of the lips before and after the procedure in both groups. The result presented below is the difference between the means after and before the procedures for each group. min value: 0 - very thin lips - worse outcome Max value: 4 - full lips- a better outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Young Females (21-30 Years Old) young healthy females (21-30 years old) from all phototypes who have thin or moderately thick lips
Hyaluronic acid filler: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation. | 22 |
| Post Menopausal Females post menopausal females from all phototypes who have thin or moderately thick lips
Hyaluronic acid filler: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation. | 11 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Young Females (21-30 Years Old) | Post Menopausal Females | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 6 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 5 Participants | 27 Participants |
| Age, Continuous | 24.72 years STANDARD_DEVIATION 2.64 | 69.91 years STANDARD_DEVIATION 10.97 | 39.79 years STANDARD_DEVIATION 22.58 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 9 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 22 participants | 11 participants | 33 participants |
| Sex: Female, Male Female | 22 Participants | 11 Participants | 33 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 11 |
| other Total, other adverse events | 2 / 22 | 0 / 11 |
| serious Total, serious adverse events | 0 / 22 | 0 / 11 |
Outcome results
Primary
Change in Lip Vessel's Thickness
Pre and post-treatment lip vessel thickness was measured in µm using Optical Coherence Tomography-Angiography imaging. For each age group, pre and post-treatment means were calculated. The difference between the post and the pre-treatment means is shown below (post-treatment mean - pre-treatment mean).
Time frame: Day 1 and Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Young Females (21-30 Years Old) | Change in Lip Vessel's Thickness | 0.833 µm | Standard Deviation 1.334 |
| Post Menopausal Females | Change in Lip Vessel's Thickness | 0.360 µm | Standard Deviation 1.543 |
Secondary
Lip Fullness Measurement (Measures the Increase of Lip's Size After the Procedure)
The Lip Fullness Grading Scale was used to measure the size of the lips before and after the procedure in both groups. The result presented below is the difference between the means after and before the procedures for each group. min value: 0 - very thin lips - worse outcome Max value: 4 - full lips- a better outcome
Time frame: D1 and D14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Young Females (21-30 Years Old) | Lip Fullness Measurement (Measures the Increase of Lip's Size After the Procedure) | 1.14 units on a scale | Standard Deviation 0.52 |
| Post Menopausal Females | Lip Fullness Measurement (Measures the Increase of Lip's Size After the Procedure) | 0.78 units on a scale | Standard Deviation 0.34 |
Secondary
Wong-Baker FACES Pain Rating Scale
This scale will be used to record the subject's overall pain from the procedure. There are 6 faces ranging from 0=no pain to 10=the worst pain.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Young Females (21-30 Years Old) | Wong-Baker FACES Pain Rating Scale | 2.9 score on a scale | Standard Deviation 0.5 |
| Post Menopausal Females | Wong-Baker FACES Pain Rating Scale | 3.5 score on a scale | Standard Deviation 0.14 |