Assessment and Augmentation of Lip Appearance in Specific Study Populations

July 26, 2023 updated by: Dieter Manstein, MD
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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • MGH Clinical Unit for Research Trials & Outcomes Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Young females (21-30 years old)
young healthy females (21-30 years old) from all phototypes who have thin or moderately thick lips
Drug: Hyaluronic acid filler
Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
Other: post menopausal females
post menopausal females from all phototypes who have thin or moderately thick lips
Drug: Hyaluronic acid filler
Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 1 and Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1
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
D1 and D14

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lip color
Time Frame: Day 1 and Day 14

All non-invasive imaging (OCT, digital and Cherry Imaging) will be compared pre and post treatment for possible effects on lip color.

The Cherry Imaging analysis software contains distinct algorithms that process the generated three-dimensional images to calculate volume in cubic centimeters, precise color using saturation and hue, roughness detecting local variations in height/depth, and a ruler function that measures the distance between two distinct points.
Day 1 and Day 14
Change in Lip texture
Time Frame: Day 1 and Day 14

All non-invasive imaging (OCT, digital and Cherry Imaging) will be compared pre and post treatment for possible effects on lip texture.

The Cherry Imaging analysis software contains distinct algorithms that process the generated three-dimensional images to calculate volume in cubic centimeters, precise color using saturation and hue, roughness detecting local variations in height/depth, and a ruler function that measures the distance between two distinct points.
Day 1 and Day 14
Change in Lip volume
Time Frame: Day 1 and Day 14

All non-invasive imaging (OCT, digital and Cherry Imaging) will be compared pre and post treatment for possible effects on lip volume.

The Cherry Imaging analysis software contains distinct algorithms that process the generated three-dimensional images to calculate volume in cubic centimeters, precise color using saturation and hue, roughness detecting local variations in height/depth, and a ruler function that measures the distance between two distinct points.
Day 1 and Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dieter Manstein, MD

Investigators

  • Principal Investigator: Dieter Manstein, MD, PhD, Massachusetts General Hospital
  • Principal Investigator: Neera Nathan, MD, MSHS, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2021

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021P000010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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