NCT04755595 is a Phase 2 clinical trial of Botox Cosmetic Injectable Product in Dermatological Non-Disease, sponsored by State University of New York - Downstate Medical Center.

Who is sponsoring NCT04755595?

NCT04755595 is sponsored by State University of New York - Downstate Medical Center.

What drugs are being tested in NCT04755595?

Interventions in NCT04755595: Botox Cosmetic Injectable Product, Juvéderm Voluma XC, Juvéderm Volbella XC.

What condition does NCT04755595 study?

NCT04755595 studies Dermatological Non-Disease.

Is NCT04755595 still recruiting?

NCT04755595 is currently completed. Last updated 14 January 2025.

Are results published for NCT04755595?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-01-14 · How we verify

NCT04755595

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Combination Facial Aesthetic Treatment in Millennials

Completed Phase 2 Results posted Last updated 14 January 2025

What this trial tests

Phase 2 trial testing Botox Cosmetic Injectable Product in Dermatological Non-Disease in 20 participants. Completed in 19 May 2021.

Timeline

9 March 2021

Primary endpoint
19 May 2021

19 May 2021

Quick facts

Lead sponsor	State University of New York - Downstate Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	9 March 2021
Primary completion	19 May 2021
Estimated completion	19 May 2021
Sites	1 location across United States

Drugs / interventions tested

Botox Cosmetic Injectable Product — full drug profile →
Juvéderm Voluma XC
Juvéderm Volbella XC

Conditions studied

Dermatological Non-Disease — all drugs for Dermatological Non-Disease →

Sponsor

State University of New York - Downstate Medical Center

Who can join

Adults 24 to 40, any sex, with Dermatological Non-Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

FACE-Q Satisfaction With Facial Appearance Overall Scale Primary · Baseline and 2 months after the procedure

To assess changes in patient's satisfaction with their appearance following a combination facial aesthetic treatment, using the FACE-Q Satisfaction with Facial Appearance Overall Scale. This tool consists of several questions. For each question, the study participant selects a number from 1 to 4. Higher number are associated with higher satisfaction with facial appearance. The raw scores of the primary outcome measure were transformed by the Rasch measurement method into a 0-to-100 point scale.

Group	Value	95% CI
Baseline	42.35	± 8.94
Post-treatment	59.42	± 15.08

FACE-Q Appraisal of Lines Overall Secondary · Baseline and 2 months after the procedure

To assess changes in patient dissatisfaction with the appearance of overall facial lines, using the FACE-Q Appraisal of Lines: Overall Scale. The tool consists of ten questions regarding self-perception of overall facial lines. For each question, study participants select a number from 1 to 4, with higher numbers reflecting greater dissatisfaction with facial lines. The total score is tallied. The minimum total score is 10 and the maximum total score is 40. A higher total score is associated with greater dissatisfaction with facial lines. The mean total score at baseline and 2 months post proc

Group	Value	95% CI
Baseline	21.5	± 6.8
Post-treatment	15.1	± 3.2

FACE-Q Expectations Scale Secondary · At baseline

To assess patient expectations regarding the impact of facial aesthetic treatment on their lives, using the FACE-Q Expectations Scale. This tool consists of eight statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score of the statements is tallied. The minimum total score is 8 and the maximum total score is 32. The higher the total score, the greater positive impact the participants believe the treatments wil

Group	Value	95% CI
Baseline	17.4	± 4.6

FACE-Q Social Function Scale Secondary · Baseline and 2 months after the procedure

To assess changes in psychosocial factors after facial aesthetic treatment, using FACE-Q Social Function Scale. This tool consists of eight statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score of the statements is tallied for each patient. The minimum total score is 8 and the maximum total score is 32. A higher total score reflects greater social functioning. The mean total score is reported at baseline an

Group	Value	95% CI
Baseline	24.4	± 4.6
Post-treatment	27.4	± 4.3

FACE-Q Patient-Perceived Age Visual Analogue Scale Secondary · Baseline and 2 months after the procedure

To assess changes in self-perceived age after facial aesthetic treatment, using the FACE-Q Patient-Perceived Age Visual Analogue Scale. The study participant selects a number on the scale from -15 to +15. 0 corresponds to "I look my age". -15 corresponds to "I look 15 years younger". +15 corresponds to "I look 15 years older". The mean score at baseline and 2 months post procedure are reported.

Group	Value	95% CI
Baseline	0.2	± 2.3
Post-treatment	-2.2	± 3.1

FACE-Q Satisfaction With Cheeks Secondary · Baseline and 2 months after the procedure

To assess changes in patient satisfaction with the appearance of their cheeks after facial aesthetic treatment, using the FACE-Q Satisfaction with Cheeks Scale. The tool consists of five questions regarding self-perception of cheeks. For each question, study participants select a number from 1 to 4, with higher numbers reflecting greater satisfaction with cheeks. The total score is tallied. The minimum total score is 5 and the maximum total score is 20. A higher total score is associated with greater satisfaction with cheeks. The mean total score at baseline and 2 months post procedure are rep

Group	Value	95% CI
Baseline	13.3	± 3.4
Post-treatment	16.9	± 2.1

FACE-Q Satisfaction With Outcome Scale Secondary · 2 months after the procedure

To assess patient satisfaction with facial aesthetic treatment, using the FACE-Q Satisfaction with Outcome Scale. This tool consists of six statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score is tallied. The minimum total score is 6 and the maximum total score is 24. A higher total score is associated with greater satisfaction with outcome. The mean total score 2 months after the procedure is reported.

Group	Value	95% CI
Post-treatment	20.8	± 2.9

FACE-Q Psychological Function Scale Secondary · Baseline and 2 months after the procedure

To assess changes in psychosocial factors after facial aesthetic treatment, using the FACE-Q Psychological Function Scale. This tool consists of ten statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score is tallied. The minimum total score is 10 and the maximum total score is 40. A higher total score is associated with better psychological functioning. The mean total score at baseline and 2 months after the

Group	Value	95% CI
Baseline	30.5	± 8.2
Post-treatment	34.9	± 5.1

FACE-Q Aging Appraisal Scale Secondary · 2 months after the procedure compared to baseline

To assess changes in self-perceived age after facial aesthetic treatment, using the FACE-Q Aging Appraisal Scale. This tool consists of seven statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score is tallied. The minimum total score is 7 and the maximum total score is 28. A lower total score is associated with greater satisfaction with self-perceived age. The mean total score at baseline and 2 months after t

Group	Value	95% CI
Baseline	12.6	± 5.6
Post-treatment	9.8	± 4.8

FACE-Q Satisfaction With Lips Secondary · Baseline and 2 months after the procedure

To assess changes in patient satisfaction with the appearance of their lips after facial aesthetic treatment, using the FACE-Q Satisfaction with Lips Scale. The tool consists of ten questions regarding self-perception of lips. For each question, study participants select a number from 1 to 4, with higher numbers reflecting greater satisfaction with lips. The total score is tallied. The minimum total score is 10 and the maximum total score is 40. A higher total score is associated with greater satisfaction with lips. The mean total score at baseline and 2 months post procedure are reported.

Group	Value	95% CI
Baseline	25.4	± 7.3
Post-treatment	34.9	± 4.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected over two months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Facial Aesthetic Treatment

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (5 terms — click to expand)

Reaction	System	Facial Aesthetic Treatment
Edema	Skin and subcutaneous tissue disorders	—
Bruising	Skin and subcutaneous tissue disorders	—
Headache	General disorders	—
Soreness	General disorders	—
Lumps localized to midface dermal filler injection sites	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT04755595 adverse events section.

Sponsor's own description

With 63% of consumers willing to consider investing in facial aesthetics and 73% of consumers worldwide expecting to invest in aesthetic treatments in the upcoming year, it is imperative to explore patient satisfaction and psychosocial impact of a multimodal aesthetic treatment in a millennial cohort. The investigators hypothesize that a combination approach to facial aesthetic treatment in a millennial cohort will result in increased patient-reported satisfaction in multiple areas, including perception of aging concerns and quality of life.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04755595 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by State University of New York - Downstate Medical Center
Last refreshed: 14 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04755595.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing