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Completed

NCT Number: NCT04839692

Assessment and Augmentation of Lip Appearance in Specific Study Populations

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.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

MGH Clinical Unit for Research Trials & Outcomes Research

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyaluronic acid filler

Drug

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

Primary outcomes

  1. Change in Lip Vessel's Thickness

    Time frame: 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 outcomes

  1. Wong-Baker FACES Pain Rating Scale

    Time frame: 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.

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Dieter Manstein, MD

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 9, 2021
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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