Clinical trial NCT04839692: Assessment and Augmentation of Lip Appearance in Specific Study Populations
Official title: Assessment and Augmentation of Lip Appearance in Specific Study Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lip Aging
Lip Augmentation
Lip
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 37
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Lip Vessel's Thickness
timeFrame: Day 1 and Day 14
Secondary outcomes:
measure: Wong-Baker FACES Pain Rating Scale
timeFrame: Day 1
measure: Lip Fullness Measurement (Measures the Increase of Lip's Size After the Procedure)
timeFrame: D1 and D14
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH Clinical Unit for Research Trials & Outcomes Research
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Dieter Manstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Neera Nathan, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uitto J. Understanding premature skin aging. N Engl J Med. 1997 Nov 13;337(20):1463-5. doi: 10.1056/NEJM199711133372011. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.