Lip AgingPhase 4NCT04839692
Assessment and Augmentation of Lip Appearance in Specific Study Populations
A Phase 4 study testing Hyaluronic acid filler in people with Lip Aging and Lip Augmentation, run by Dieter Manstein, MD at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lip Aging, Lip Augmentation, Lip
- What is being tested?
- Hyaluronic acid filler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2021to 1 Aug 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Clinical Unit for Research Trials & Outcomes Research
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Lip Aging, Lip Augmentation, Lip
- Being tested
- Hyaluronic acid filler
- Medical subject headings
- Lymphoid Interstitial Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid fillerDrug
Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
| Study group | Role | What they receive |
|---|---|---|
| Young females (21-30 years old) | Other | young healthy females (21-30 years old) from all phototypes who have thin or moderately thick lips Receives: Drug: Hyaluronic acid filler |
| post menopausal females | Other | post menopausal females from all phototypes who have thin or moderately thick lips Receives: Drug: Hyaluronic acid filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1 and Day 14
Secondary outcomes (2)
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.
Measured: Day 1
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
Measured: D1 and D14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start7 May 2021
- Primary completion1 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Lip AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dieter Manstein, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dieter Manstein, MD, Massachusetts General Hospital
- Investigators
- Dieter Manstein, MD, PhD, Principal investigator, Massachusetts General HospitalNeera Nathan, MD, MSHS, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839692
- Sponsor's protocol ID
- 2021P000010
- Status last verified
- Jul 2023
- First submitted
- 25 Feb 2021
- Last updated
- 28 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
Uitto J. Understanding premature skin aging. N Engl J Med. 1997 Nov 13;337(20):1463-5. doi: 10.1056/NEJM199711133372011. No abstract available.
PubMed 9358147Zouboulis 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.
PubMed 12955259Leung 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.
PubMed 12452869Argyropoulos 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.
PubMed 27104752van 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.
PubMed 28632785Gilchrest 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.
PubMed 6886112Rogers 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.
PubMed 2186787Bentov 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.
PubMed 25917013Tamura 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.
PubMed 29405429Hilton 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.
PubMed 29059146Stojanovic 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.
PubMed 30636365Savoia 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.
PubMed 24436079Carruthers 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.
PubMed 19021674
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Augmentation of Lip Appearance in Specific Study Populations
- ClinicalTrials.gov ID
- NCT04839692
- Acronym / sponsor ID
- 2021P000010
- Conditions
- Lip Aging, Lip Augmentation, Lip
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Dieter Manstein, MDUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Posted 28 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Young females (21-30 years old) | Other | Drug: Hyaluronic acid filleryoung healthy females (21-30 years old) from all phototypes who have thin or moderately thick lips |
| post menopausal females | Other | Drug: Hyaluronic acid fillerpost menopausal females from all phototypes who have thin or moderately thick lips |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acid fillerHyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation. | Drug | Young females (21-30 years old), post menopausal females |
Primary outcome
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).
2 secondary outcomes
Wong-Baker FACES Pain Rating Scale
Time frame: Day 1
Lip Fullness Measurement (Measures the Increase of Lip's Size After the Procedure)
Time frame: D1 and D14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9358147Uitto J. Understanding premature skin aging. N Engl J Med. 1997 Nov 13;337(20):1463-5. doi: 10.1056/NEJM199711133372011. No abstract available.
- Background: PubMed 12955259Zouboulis 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.
- Background: PubMed 12452869Leung 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.
- Background: PubMed 27104752Argyropoulos 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.
- Background: PubMed 28632785van 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.
- Background: PubMed 6886112Gilchrest 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.
- Background: PubMed 2186787Rogers 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.
- Background: PubMed 25917013Bentov 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.
- Background: PubMed 29405429Tamura 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.
- Background: PubMed 29059146Hilton 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.
- Background: PubMed 30636365Stojanovic 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.
- Background: PubMed 24436079Savoia 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.
- Restylane Kysse Patient BrochureLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieter Manstein, MD, PhD principal investigator
Massachusetts General Hospital
Neera Nathan, MD, MSHS principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronic acid filler in people with Lip Aging and Lip Augmentation, run by Dieter Manstein, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lip Vessel's Thickness (time frame: Day 1 and Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04839692, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.