A Safety and Effectiveness Study of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02833077
• Collaborator: (none)
• Enrollment: 221
• Locations: 14
• Arms: 2
• Actual Duration (Months): 27.4
• Patients Per Site: 15.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This is a safety and effectiveness study of JUVÉDERM VOLUMA XC injectable gel for chin augmentation to correct volume deficit in chin retrusion.

Condition or Disease	Intervention/Treatment	Phase
Chin Retrusion	Device: JUVÉDERM VOLUMA® XC	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 221 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation
• Actual Study Start Date: Jun 28, 2016
• Actual Primary Completion Date: Feb 6, 2018
• Actual Study Completion Date: Oct 11, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JUVÉDERM VOLUMA® XC JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator on Day 0. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 milliliters (mL) for both treatments combined.	Device: JUVÉDERM VOLUMA® XC; JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator. The maximum total volume administered was up to 4 mL.
Other: No Treatment then JUVÉDERM VOLUMA® XC No treatment for 6 months followed by optional treatment with JUVÉDERM VOLUMA® XC injected into the chin at a volume determined by the investigator on Month 6. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.	Device: JUVÉDERM VOLUMA® XC; JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator. The maximum total volume administered was up to 4 mL.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score [Baseline (up to 30 days prior to randomization) to Month 6]

   The evaluating investigator assessed the participant's chin retrusion based on 2-dimensional (2D) renderings of 3-dimensional (3D) images using the validated 5-point photonumeric ACRS where: 0= None (no chin retrusion) to 4=Extreme (extreme chin retrusion).

Secondary Outcome Measures

1. Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire [Baseline (up to 30 days prior to randomization) to Month 6]

   The participant answered 10 question on the chin module of the FACE-Q about their satisfaction with their chin using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied and 4=Very Satisfied. The total score was transformed to a score of 0 (worse) to 100 (best). A positive change from Baseline indicates improvement.

2. Percentage of Participants Improved or Much Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS) for the Chin Area As Assessed by the Evaluating Investigator [Baseline (up to 30 days prior to randomization) to Month 6]

   The evaluating investigator assessed the participant's chin area using the GAIS where: 2=Much Improved, 1=Improved, 0=No change, -1=Worse and -2=Much Worse.

3. Percentage of Participants Improved or Much Improved on the 5-Point GAIS for the Chin Area As Assessed by the Participants [Baseline (up to 30 days prior to randomization) to Month 6]

   The participants who received JUVÉDERM VOLUMA® XC, assessed their chin area using the GAIS where: 2=Much Improved, 1=Improved, 0=No change, -1=Worse and -2=Much Worse.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Chin retrusion

• In good general health

Exclusion Criteria:

• Permanent facial implants on the face and/or neck

• Received fat injections below the nose

• Tattoos, piercings, beard, mustache, and/or scars on the face below the nose

• Received semi-permanent dermal fillers in the chin or jaw line in the last 3 years

• Undergone dermal filler injections or had any surgery in the chin or jaw area in the last 2 years

• Received dermal filler injections in the lips or in the mouth area in the last 12 months

• Undergone mesotherapy or cosmetic treatment (e.g., laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, liposuction, lipolysis, or other ablative procedures) anywhere in the face or neck in the last 6 months

• Received botulinum toxin treatment below the nose in the last 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.	San Diego	California	United States	92121
2	Skin Research Institute	Coral Gables	Florida	United States	33146
3	Baumann Cosmetic and Res. Institute	Miami Beach	Florida	United States	33137
4	Research Institute of the Southeast	West Palm Beach	Florida	United States	33401
5	DeNova Research	Chicago	Illinois	United States	60611
6	Callender Dermatology and Cosmetic Center	Glenn Dale	Maryland	United States	20769
7	SkinCare Physicians of Chestnut Hill	Chestnut Hill	Massachusetts	United States	01467
8	St Louis University Medical Center Dept. of Dermatology	Saint Louis	Missouri	United States	63104
9	Image Dermatology, PC	Montclair	New Jersey	United States	07042
10	Williams Plastic Surgery Specialists	Latham	New York	United States	12110
11	The Center for Dermatology, Cosmetics, & Laser Surgery	Mount Kisco	New York	United States	10549
12	Dermatology & Laser Center of Charleston Center for Clinical Research	Charleston	South Carolina	United States	29414
13	Nashville Centre for Laser and Facial Surgery	Nashville	Tennessee	United States	37203
14	Premier Clinical Research; Spokane Dermatology Clinic	Spokane	Washington	United States	99202

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Andrew Schumacher, Allergan

Study Documents (Full-Text)

• Statistical Analysis Plan - Feb 28, 2017
• Study Protocol - Mar 1, 2017

More Information

Additional Information:

• More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT02833077
• Other Study ID Numbers: Voluma-006
• First Posted: Jul 14, 2016
• Last Update Posted: Jul 23, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

Participant Flow

Recruitment Details	A total of 221 participants were enrolled in the study, with enrollment defined as signing the informed consent form. A total of 29 enrolled participants were screen failures (did not meet eligibility criteria). Thus, a total of 192 participants were randomized.

Arm/Group Title	JUVÉDERM VOLUMA® XC	No Treatment Then JUVÉDERM VOLUMA® XC
Arm/Group Description	JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator on Day 0. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 milliliters (mL) for both treatments combined.	No treatment for 6 months followed by optional treatment with JUVÉDERM VOLUMA® XC injected into the chin at a volume determined by the investigator on Month 6. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.
Period Title: Overall Study
STARTED	144	48
Participants Treated	144	38
COMPLETED	127	40
NOT COMPLETED	17	8

Baseline Characteristics

Arm/Group Title	JUVÉDERM VOLUMA® XC	No Treatment Then JUVÉDERM VOLUMA® XC	Total
Arm/Group Description	JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator on Day 0. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.	No treatment for 6 months followed by optional treatment with JUVÉDERM VOLUMA® XC injected into the chin at a volume determined by the investigator on Month 6. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.	Total of all reporting groups
Overall Participants	144	48	192
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.1 (13.4)	48.9 (14.3)	49.8 (13.6)
Sex: Female, Male (Count of Participants)
Female	129 89.6%	41 85.4%	170 88.5%
Male	15 10.4%	7 14.6%	22 11.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	27 18.8%	6 12.5%	33 17.2%
Not Hispanic or Latino	117 81.3%	42 87.5%	159 82.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 2.1%	0 0%	3 1.6%
Asian	1 0.7%	0 0%	1 0.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	23 16%	6 12.5%	29 15.1%
White	116 80.6%	41 85.4%	157 81.8%
More than one race	1 0.7%	1 2.1%	2 1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
North America	144 100%	48 100%	192 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score
Description	The evaluating investigator assessed the participant's chin retrusion based on 2-dimensional (2D) renderings of 3-dimensional (3D) images using the validated 5-point photonumeric ACRS where: 0= None (no chin retrusion) to 4=Extreme (extreme chin retrusion).
Time Frame	Baseline (up to 30 days prior to randomization) to Month 6

Outcome Measure Data

Analysis Population Description

The mITT population included all participants randomized to the treatment group who received at least 1 study treatment or all participants randomized to the control group. Overall number of participants analyzed were the participants with analysis values at both Baseline and Post-baseline during the specified time period.

Arm/Group Title	JUVÉDERM VOLUMA® XC	No Treatment Then JUVÉDERM VOLUMA® XC
Arm/Group Description	JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator on Day 0. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.	No treatment for 6 months followed by optional treatment with JUVÉDERM VOLUMA® XC injected into the chin at a volume determined by the investigator on Month 6. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.
Measure Participants	126	40
Number [percentage of participants]	56.3 39.1%	27.5 57.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	JUVÉDERM VOLUMA® XC, No Treatment Then JUVÉDERM VOLUMA® XC
	Comments	Superiority of treatment group was established if responder rate at month 6 was statistically greater than that for the control group at month 6 and the observed responder rate at month 6 for the treatment group was greater than 50%.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0019
	Comments	If the 2-sided p-value is < 0.05, the responder rate is greater for treatment than for control group, and point estimate of the responder rater for treatment group is greater than 50%, then treatment will be considered superior to control group.
	Method	Fisher's exact test
	Comments
Method of Estimation	Estimation Parameter	Responder Rate Difference
	Estimated Value	28.85
	Confidence Interval	(2-Sided) 95%; 11.16 to 45.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire
Description	The participant answered 10 question on the chin module of the FACE-Q about their satisfaction with their chin using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied and 4=Very Satisfied. The total score was transformed to a score of 0 (worse) to 100 (best). A positive change from Baseline indicates improvement.
Time Frame	Baseline (up to 30 days prior to randomization) to Month 6

Outcome Measure Data

Analysis Population Description

The mITT population included all participants randomized to the treatment group who received at least 1 study treatment or all participants randomized to the control group. Overall number of participants analyzed were the participants with analysis values at both Baseline and Post-baseline during the specified time period.

Arm/Group Title	JUVÉDERM VOLUMA® XC	No Treatment Then JUVÉDERM VOLUMA® XC
Arm/Group Description	JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator on Day 0. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.	No treatment for 6 months followed by optional treatment with JUVÉDERM VOLUMA® XC injected into the chin at a volume determined by the investigator on Month 6. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.
Measure Participants	126	40
Baseline	35.7 (17.7)	35.3 (14.9)
Change from Baseline to Month 6	35.6 (23.2)	-3.3 (11.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	JUVÉDERM VOLUMA® XC
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments	P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean overall satisfaction score at month 6 visit is statistically greater than that at the baseline for the treatment group.
	Method	Two sided paired t-test
	Comments

3. Secondary Outcome

Title	Percentage of Participants Improved or Much Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS) for the Chin Area As Assessed by the Evaluating Investigator
Description	The evaluating investigator assessed the participant's chin area using the GAIS where: 2=Much Improved, 1=Improved, 0=No change, -1=Worse and -2=Much Worse.
Time Frame	Baseline (up to 30 days prior to randomization) to Month 6

Outcome Measure Data

Analysis Population Description

The mITT population included all participants randomized to the treatment group who received at least 1 study treatment or all participants randomized to the control group. Overall number analyzed is the number of participants with data available for analyses.

Arm/Group Title	JUVÉDERM VOLUMA® XC	No Treatment Then JUVÉDERM VOLUMA® XC
Arm/Group Description	JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator on Day 0. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.	No treatment for 6 months followed by optional treatment with JUVÉDERM VOLUMA® XC injected into the chin at a volume determined by the investigator on Month 6. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.
Measure Participants	125	41
Number [percentage of participants]	91.2 63.3%	19.5 40.6%

4. Secondary Outcome

Title	Percentage of Participants Improved or Much Improved on the 5-Point GAIS for the Chin Area As Assessed by the Participants
Description	The participants who received JUVÉDERM VOLUMA® XC, assessed their chin area using the GAIS where: 2=Much Improved, 1=Improved, 0=No change, -1=Worse and -2=Much Worse.
Time Frame	Baseline (up to 30 days prior to randomization) to Month 6

Outcome Measure Data

Analysis Population Description

Participants in the mITT population who were randomized to the treatment group and received at least 1 study treatment with available data were included in the analyses.

Arm/Group Title	JUVÉDERM VOLUMA® XC
Arm/Group Description	JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator on Day 0. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.
Measure Participants	126
Number [percentage of participants]	87.3 60.6%

Adverse Events

Time Frame	JUVÉDERM VOLUMA® XC: Up to 12 months following treatment. No Treatment then JUVÉDERM VOLUMA® XC: Up to 6 months during No Treatment; Up to 6 months following treatment (Up to Month 12)
Adverse Event Reporting Description	Safety population included all participants randomized to the treatment group who received at least 1 study device treatment or all participants randomized to the control group.
Arm/Group Title	JUVÉDERM VOLUMA® XC		No Treatment		JUVÉDERM VOLUMA® XC After No Treatment
Arm/Group Description	JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator on Day 0. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.		Participants who received no treatment for the first 6 months.		Participants who received optional treatment with JUVÉDERM VOLUMA® XC injected into the chin at a volume determined by the investigator on Month 6 after no treatment for 6 months. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.
All Cause Mortality
	JUVÉDERM VOLUMA® XC		No Treatment		JUVÉDERM VOLUMA® XC After No Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/144 (0%)		0/48 (0%)		0/38 (0%)
Serious Adverse Events
	JUVÉDERM VOLUMA® XC		No Treatment		JUVÉDERM VOLUMA® XC After No Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/144 (6.9%)		4/48 (8.3%)		1/38 (2.6%)
General disorders
Non-cardiac chest pain	1/144 (0.7%)		0/48 (0%)		0/38 (0%)
Injection site inflammation	1/144 (0.7%)		0/48 (0%)		0/38 (0%)
Hepatobiliary disorders
Cholecystitis	0/144 (0%)		0/48 (0%)		1/38 (2.6%)
Infections and infestations
Appendicitis	1/144 (0.7%)		0/48 (0%)		0/38 (0%)
Pneumonia	1/144 (0.7%)		1/48 (2.1%)		0/38 (0%)
Injection site cellulitis	1/144 (0.7%)		0/48 (0%)		0/38 (0%)
Diverticulitis	1/144 (0.7%)		0/48 (0%)		0/38 (0%)
Atypical pneumonia	1/144 (0.7%)		0/48 (0%)		0/38 (0%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/144 (0.7%)		0/48 (0%)		0/38 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin	1/144 (0.7%)		0/48 (0%)		0/38 (0%)
Intraductal proliferative breast lesion	1/144 (0.7%)		0/48 (0%)		0/38 (0%)
Invasive papillary breast carcinoma	1/144 (0.7%)		0/48 (0%)		0/38 (0%)
Keratoacanthoma	1/144 (0.7%)		0/48 (0%)		0/38 (0%)
Squamous cell carcinoma	0/144 (0%)		1/48 (2.1%)		0/38 (0%)
Colon cancer	0/144 (0%)		1/48 (2.1%)		0/38 (0%)
Breast cancer stage IV	0/144 (0%)		1/48 (2.1%)		0/38 (0%)
Reproductive system and breast disorders
Uterine haemorrhage	1/144 (0.7%)		0/48 (0%)		0/38 (0%)
Other (Not Including Serious) Adverse Events
	JUVÉDERM VOLUMA® XC		No Treatment		JUVÉDERM VOLUMA® XC After No Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/144 (0%)		0/48 (0%)		0/38 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.