Assessment and Augmentation of Lip Appearance in Specific Study Populations

NCT04839692 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2021P000010
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Lip Aging; Lip Augmentation; Lip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Wong-Baker FACES Pain Rating Scale

  Day 1

• Lip Fullness Measurement (Measures the Increase of Lip's Size After the Procedure)

  D1 and D14

Study Arms (2)

Young females (21-30 years old)

OTHER

young healthy females (21-30 years old) from all phototypes who have thin or moderately thick lips

Drug: Hyaluronic acid filler

post menopausal females

OTHER

post menopausal females from all phototypes who have thin or moderately thick lips

Drug: Hyaluronic acid filler

Interventions

Hyaluronic acid filler DRUG

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

Young females (21-30 years old); post menopausal females

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Dieter Manstein, MD: lead

Study Sites (1)

MGH Clinical Unit for Research Trials & Outcomes Research

Boston, Massachusetts, 02114, United States

Location

Related Publications (13)

• Uitto J. Understanding premature skin aging. N Engl J Med. 1997 Nov 13;337(20):1463-5. doi: 10.1056/NEJM199711133372011. No abstract available.

  PMID: 9358147 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.

  PMID: 12955259 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.

  PMID: 12452869 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.

  PMID: 27104752 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.

  PMID: 28632785 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.

  PMID: 6886112 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.

  PMID: 2186787 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.

  PMID: 25917013 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.

  PMID: 29405429 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.

  PMID: 29059146 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.

  PMID: 30636365 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.

  PMID: 24436079 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.

  PMID: 19021674 BACKGROUND

Related Links

• Restylane Kysse Patient Brochure

MeSH Terms

Conditions

Lymphoid Interstitial Pneumonia

Limitations and Caveats

Smaller number of subjects in postmenopausal group due to the difficulties in recruitment

Results Point of Contact

• Title: Dr. Dieter Manstein
• Organization: Massachusetts General Hospital

dmanstein@mgh.harvard.edu

617-726-4893

Study Officials

• Dieter Manstein, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Neera Nathan, MD, MSHS

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Standard photographs will be blindly reviewed by a physician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: April 9, 2021
• Study Start: May 7, 2021
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: July 28, 2023
• Results First Posted: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)