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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Young females (21-30 years old) | Other | young healthy females (21-30 years old) from all phototypes who have thin or moderately thick lips |
|
| post menopausal females | Other | post menopausal females from all phototypes who have thin or moderately thick lips |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid filler | Drug | Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 1 and Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Lip Fullness Measurement (Measures the Increase of Lip's Size After the Procedure) |
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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 );
Have very thin to moderately thick lips (Lip Fullness Grading Scale [LFGS] scores 0-2).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dieter Manstein, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Neera Nathan, MD, MSHS | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH Clinical Unit for Research Trials & Outcomes Research | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9358147 | Background | Uitto J. Understanding premature skin aging. N Engl J Med. 1997 Nov 13;337(20):1463-5. doi: 10.1056/NEJM199711133372011. No abstract available. | |
| 12955259 | Background | Zouboulis ChC. [Intrinsic skin aging. A critical appraisal of the role of hormones]. Hautarzt. 2003 Sep;54(9):825-32. doi: 10.1007/s00105-003-0581-7. German. |
| Label | URL |
|---|---|
| Restylane Kysse Patient Brochure | View source |
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There is no plan to make individual participant data (IPD) available to other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | µm | Day 1 and Day 14 |
|
21 days
Minimal-risk study with healthy participants. Two subjects from the young arm presented lip asymmetry as an adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asymmetry | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Asymmetry of lips |
Smaller number of subjects in postmenopausal group due to the difficulties in recruitment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dieter Manstein | Massachusetts General Hospital | 617-726-4893 | dmanstein@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 29, 2021 | Nov 30, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 18, 2022 | Nov 30, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C562489 | Lymphoid Interstitial Pneumonia |
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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.
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Standard photographs will be blindly reviewed by a physician.
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 |
| D1 and D14 |
| 12452869 | Background | Leung WC, Harvey I. Is skin ageing in the elderly caused by sun exposure or smoking? Br J Dermatol. 2002 Dec;147(6):1187-91. doi: 10.1046/j.1365-2133.2002.04991.x. |
| 27104752 | Background | Argyropoulos AJ, Robichaud P, Balimunkwe RM, Fisher GJ, Hammerberg C, Yan Y, Quan T. Alterations of Dermal Connective Tissue Collagen in Diabetes: Molecular Basis of Aged-Appearing Skin. PLoS One. 2016 Apr 22;11(4):e0153806. doi: 10.1371/journal.pone.0153806. eCollection 2016. |
| 28632785 | Background | van Waateringe RP, Mook-Kanamori MJ, Slagter SN, van der Klauw MM, van Vliet-Ostaptchouk JV, Graaff R, Lutgers HL, Suhre K, El-Din Selim MM, Mook-Kanamori DO, Wolffenbuttel BHR. The association between various smoking behaviors, cotinine biomarkers and skin autofluorescence, a marker for advanced glycation end product accumulation. PLoS One. 2017 Jun 20;12(6):e0179330. doi: 10.1371/journal.pone.0179330. eCollection 2017. |
| 6886112 | Background | Gilchrest BA, Soter NA, Hawk JL, Barr RM, Black AK, Hensby CN, Mallet AI, Greaves MW, Parrish JA. Histologic changes associated with ultraviolet A--induced erythema in normal human skin. J Am Acad Dermatol. 1983 Aug;9(2):213-9. doi: 10.1016/s0190-9622(83)70131-3. |
| 2186787 | Background | Rogers GS, Gilchrest BA. The senile epidermis: environmental influences on skin ageing and cutaneous carcinogenesis. Br J Dermatol. 1990 Apr;122 Suppl 35:55-60. doi: 10.1111/j.1365-2133.1990.tb16126.x. |
| 25917013 | Background | Bentov I, Reed MJ. The effect of aging on the cutaneous microvasculature. Microvasc Res. 2015 Jul;100:25-31. doi: 10.1016/j.mvr.2015.04.004. Epub 2015 Apr 24. |
| 29405429 | Background | Tamura E, Ishikawa J, Sugata K, Tsukahara K, Yasumori H, Yamamoto T. Age-related differences in the functional properties of lips compared with skin. Skin Res Technol. 2018 Aug;24(3):472-478. doi: 10.1111/srt.12456. Epub 2018 Feb 6. |
| 29059146 | Background | Hilton S, Sattler G, Berg AK, Samuelson U, Wong C. Randomized, Evaluator-Blinded Study Comparing Safety and Effect of Two Hyaluronic Acid Gels for Lips Enhancement. Dermatol Surg. 2018 Feb;44(2):261-269. doi: 10.1097/DSS.0000000000001282. |
| 30636365 | Background | Stojanovic L, Majdic N. Effectiveness and safety of hyaluronic acid fillers used to enhance overall lip fullness: A systematic review of clinical studies. J Cosmet Dermatol. 2019 Apr;18(2):436-443. doi: 10.1111/jocd.12861. Epub 2019 Jan 12. |
| 24436079 | Background | Savoia A, Accardo C, Vannini F, Di Pasquale B, Baldi A. Outcomes in thread lift for facial rejuvenation: a study performed with happy lift revitalizing. Dermatol Ther (Heidelb). 2014 Jun;4(1):103-14. doi: 10.1007/s13555-014-0041-6. Epub 2014 Jan 17. |
| 19021674 | Background | Carruthers A, Carruthers J, Hardas B, Kaur M, Goertelmeyer R, Jones D, Rzany B, Cohen J, Kerscher M, Flynn TC, Maas C, Sattler G, Gebauer A, Pooth R, McClure K, Simone-Korbel U, Buchner L. A validated lip fullness grading scale. Dermatol Surg. 2008 Nov;34 Suppl 2:S161-6. doi: 10.1111/j.1524-4725.2008.34365.x. |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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.
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | D1 and D14 |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 2 |
| 22 |
| EG001 | 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. | 0 | 11 | 0 | 11 | 0 | 11 |
|
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