NCT02437903 is a NA clinical trial of JUVÉDERM VOLUMA™ XC in Aging, sponsored by Baumann Cosmetic and Research Institute.

Who is sponsoring NCT02437903?

NCT02437903 is sponsored by Baumann Cosmetic and Research Institute.

What drugs are being tested in NCT02437903?

Interventions in NCT02437903: JUVÉDERM VOLUMA™ XC.

Is NCT02437903 still recruiting?

NCT02437903 is currently completed. Last updated 15 February 2018.

Are results published for NCT02437903?

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

Last reviewed 2018-02-15 · How we verify

NCT02437903

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

Open Label Study Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Temporal Regions

Completed NA Results posted Last updated 15 February 2018

What this trial tests

NA trial testing JUVÉDERM VOLUMA™ XC in Aging in 30 participants. Completed in 5 April 2017.

Timeline

7 August 2015

Primary endpoint
5 April 2017

5 April 2017

Quick facts

Lead sponsor	Baumann Cosmetic and Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	7 August 2015
Primary completion	5 April 2017
Estimated completion	5 April 2017
Sites	1 location across United States

Drugs / interventions tested

JUVÉDERM VOLUMA™ XC

Conditions studied

Aging — all drugs for Aging →

Sponsor

Baumann Cosmetic and Research Institute

Who can join

Adults 35 to 75, any sex, with Aging. 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.

Frontal Temporal Fossa Rating Scale Primary · Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12

Graded severity of the temporal line of the frontal bone (TLFB) using the Frontal Temporal Fossa Rating Scale: (these will have a picture assigned to each score.

Temporal Fossa Rating Scale at Baseline

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	10
JUVÉDERM VOLUMA™ XC	13
JUVÉDERM VOLUMA™ XC	7
JUVÉDERM VOLUMA™ XC	0

Temporal Fossa Rating Scale at Month 1

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	1
JUVÉDERM VOLUMA™ XC	27

Temporal Fossa Rating Scale at Month 3

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	4
JUVÉDERM VOLUMA™ XC	22

Temporal Fossa Rating Scale at Month 6

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	8
JUVÉDERM VOLUMA™ XC	18

Temporal Fossa Rating Scale at Month 9

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	2
JUVÉDERM VOLUMA™ XC	2
JUVÉDERM VOLUMA™ XC	21

Temporal Fossa Rating Scale at Month 12

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	5
JUVÉDERM VOLUMA™ XC	20

Investigator's Satisfaction With the Appearance of the Temporal Regions Secondary · Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12

Graded level of satisfaction with the current appearance of the temporal region making certain that the investigator is looking at the patient's right side and not the investigator's right side.

Investigator's Satisfaction at Baseline

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	0

Investigator's Satisfaction at Month 1

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	24
JUVÉDERM VOLUMA™ XC	4
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	0

Investigator's Satisfaction at Month 3

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	23
JUVÉDERM VOLUMA™ XC	3
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	0

Investigator's Satisfaction at Month 6

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	18
JUVÉDERM VOLUMA™ XC	7
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	0

Investigator's Satisfaction at Month 9

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	19
JUVÉDERM VOLUMA™ XC	3
JUVÉDERM VOLUMA™ XC	1
JUVÉDERM VOLUMA™ XC	0

Investigator's Satisfaction at Month 12

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	16
JUVÉDERM VOLUMA™ XC	5
JUVÉDERM VOLUMA™ XC	3
JUVÉDERM VOLUMA™ XC	0

Subject's Satisfaction With Temple Appearance Secondary · Baseline, month 1, month 3, month 6, month 9, and Month 12

Subject's Satisfaction with Temple Appearance

Subject's Satisfaction at Baseline

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	2

Subject's Satisfaction at Month 1

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	18
JUVÉDERM VOLUMA™ XC	9
JUVÉDERM VOLUMA™ XC	1
JUVÉDERM VOLUMA™ XC	0

Subject's Satisfaction at Month 3

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	21
JUVÉDERM VOLUMA™ XC	3
JUVÉDERM VOLUMA™ XC	2
JUVÉDERM VOLUMA™ XC	0

Subject's Satisfaction at Month 6

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	15
JUVÉDERM VOLUMA™ XC	7
JUVÉDERM VOLUMA™ XC	3
JUVÉDERM VOLUMA™ XC	1

Subject's Satisfaction at Month 9

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	13
JUVÉDERM VOLUMA™ XC	6
JUVÉDERM VOLUMA™ XC	4
JUVÉDERM VOLUMA™ XC	1

Subject's Satisfaction at Month 12

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	14
JUVÉDERM VOLUMA™ XC	5
JUVÉDERM VOLUMA™ XC	3
JUVÉDERM VOLUMA™ XC	1

Subject Self-Perception of Age Secondary · Baseline, month 1, month 3, month 6, month 9, and Month 12

Subjects perception of age when the subject looks at his/her right and left temples

Subjects perception of age at Baseline

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	23
JUVÉDERM VOLUMA™ XC	4
JUVÉDERM VOLUMA™ XC	3
JUVÉDERM VOLUMA™ XC	0

Subjects perception of age at Month 1

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	5
JUVÉDERM VOLUMA™ XC	14
JUVÉDERM VOLUMA™ XC	9
JUVÉDERM VOLUMA™ XC	1

Subjects perception of age at Month 3

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	2
JUVÉDERM VOLUMA™ XC	12
JUVÉDERM VOLUMA™ XC	8
JUVÉDERM VOLUMA™ XC	3

Subjects perception of age at Month 6

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	2
JUVÉDERM VOLUMA™ XC	12
JUVÉDERM VOLUMA™ XC	10
JUVÉDERM VOLUMA™ XC	0

Subjects perception of age at Month 9

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	2
JUVÉDERM VOLUMA™ XC	11
JUVÉDERM VOLUMA™ XC	7
JUVÉDERM VOLUMA™ XC	2

Subjects perception of age Month 12

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	2
JUVÉDERM VOLUMA™ XC	12
JUVÉDERM VOLUMA™ XC	8
JUVÉDERM VOLUMA™ XC	0

Number of Participants With Specific Site Treatment Responses Secondary · Day 14

Site treatment response reported by subject on diary day 0-14 post initial injection and touch-up injections

Tenderness/Pain

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	17
JUVÉDERM VOLUMA™ XC	3
JUVÉDERM VOLUMA™ XC	1

Swelling

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	17
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	0

Lumps/Bumps

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	7
JUVÉDERM VOLUMA™ XC	1
JUVÉDERM VOLUMA™ XC	1

Bruising

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	8
JUVÉDERM VOLUMA™ XC	0
JUVÉDERM VOLUMA™ XC	0

Redness

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	7
JUVÉDERM VOLUMA™ XC	1
JUVÉDERM VOLUMA™ XC	0

Itching

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	3
JUVÉDERM VOLUMA™ XC	1
JUVÉDERM VOLUMA™ XC	0

Headache

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	7
JUVÉDERM VOLUMA™ XC	3
JUVÉDERM VOLUMA™ XC	0

Jaw Pain/Tension

Group	Value	95% CI
JUVÉDERM VOLUMA™ XC	7
JUVÉDERM VOLUMA™ XC	4
JUVÉDERM VOLUMA™ XC	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

JUVÉDERM VOLUMA™ XC

Serious: 0/30 (0%)

Deaths: 0/30

Other adverse events (1 terms — click to expand)

Reaction	System	JUVÉDERM VOLUMA™ XC
Unexpected Swelling	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT02437903 adverse events section.

Sponsor's own description

This study is to determine the efficacy and safety of JUVÉDERM VOLUMA™ XC when used in the facial temporal regions based on the change in the score of the investigator's Temporal. This study will be an open label, single center study.

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:

Other trials of JUVÉDERM VOLUMA™ XC

Trials testing the same drug.

NCT04389866 — Jowl Improvement With Injectable Fillers · NA · completed

Other recruiting trials for Aging

Currently open trials in the same condition.

NCT02831335 — Technical Development of Multi-Parametric Renocerebral MRI · recruiting
NCT07099053 — Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging · recruiting
NCT07504068 — Effects of Physical Exercise and a Nutritional Supplement on Body Composition, Metabolic Function, and Overall Health in · NA · recruiting
NCT07525453 — Effects of Three Different Exercise Programs on Dynamic Balance in Community-Dwelling Older Adults · NA · recruiting
NCT07500727 — Skeletal Muscle Aging and Responsiveness in Aged People With MS · NA · recruiting

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 NCT02437903 (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 Baumann Cosmetic and Research Institute
Last refreshed: 15 February 2018

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/NCT02437903.

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