Assessment and Augmentation of Lip Appearance in Specific Study Populations

Lip Augmentation Clinical Trial

Official title:

Assessment and Augmentation of Lip Appearance in Specific Study Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04839692
• Other study ID #: 2021P000010
• Status: Completed
• Phase: Phase 4
• Start date: May 7, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: July 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lip
• Lip Aging
• Lip Augmentation

Intervention

Drug:
• Hyaluronic acid filler
Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.

Locations

Country	Name	City	State
United States	MGH Clinical Unit for Research Trials & Outcomes Research	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dieter Manstein, MD

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Day 1 and Day 14
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.	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	D1 and D14

External Links

•   Restylane Kysse Patient Brochure