A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old

• ClinicalTrials.gov Identifier: NCT04414397
• Recruitment Status: Completed
• First Posted: June 4, 2020
• Results First Posted: April 25, 2024
• Last Update Posted: April 25, 2024
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Temple Hollowing
• Interventions: Device: JUVÉDERM® VOLUMA® XC; Other: No-treatment control
• Enrollment: 205

Participant Flow

Recruitment Details
Pre-assignment Details	Of 205 participants screened, 171 were randomized, with 113 in the treatment group and 58 in the control group. One participant was randomized to the treatment group but not treated.

Arm/Group Title	No Treatment Then JUVÉDERM® VOLUMA® XC	JUVÉDERM® VOLUMA® XC
Arm/Group Description	Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.	Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Period Title: Control Period
Started	58	113 [1]
Completed	56	106
Not Completed	2	7
Reason Not Completed
Withdrawal by Subject	2	2
Lost to Follow-up	0	4
Protocol deviation	0	1
[1] One participant was randomized but not treated.
Period Title: Post-Control Period
Started	53	106
Completed	46	91
Not Completed	7	15
Reason Not Completed
Withdrawal by Subject	3	6
Lost to Follow-up	4	9
Period Title: Maintenance Treatment Period
Started	0	40
Completed	0	35
Not Completed	0	5
Reason Not Completed
Withdrawal by Subject	0	2
Lost to Follow-up	0	3

Baseline Characteristics

Arm/Group Title		No Treatment Then JUVÉDERM® VOLUMA® XC	JUVÉDERM® VOLUMA® XC	Total
Arm/Group Description		Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.	Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.	Total of all reporting groups
Overall Number of Baseline Participants		58	113	171
Baseline Analysis Population Description		Modified Intent to Treat Population(mITT): all participants who were randomized and had non-missing Baseline Allergan Temple Hollowing Scale (ATHS) scores. Participants were summarized according to the randomized study intervention.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	58 participants	113 participants	171 participants
		54.4 (9.81)	54.9 (9.97)	54.7 (9.89)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	58 participants	113 participants	171 participants
	Female	47	96	143
	Male	11	17	28
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	58 participants	113 participants	171 participants
	Hispanic or Latino	14	27	41
	Not Hispanic or Latino	44	86	130
	Unknown or Not Reported	0	0	0
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	58 participants	113 participants	171 participants
	American Indian or Alaska Native	0	1	1
	Asian	1	2	3
	Native Hawaiian or Other Pacific Islander	0	0	0
	Black or African American	6	12	18
	White	48	94	142
	More than one race	3	4	7
	Unknown or Not Reported	0	0	0

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3
Description	The Evaluating Investigator assessed the participant's temple hollowing using the 5-point ATHS scale where 0=convex, rounded temple and 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.
Time Frame	Baseline, Month 3 (Control Period)

Outcome Measure Data

Analysis Population Description

Modified Intent to Treat Population(mITT): all participants who were randomized and had non-missing Baseline Allergan Temple Hollowing Scale (ATHS) scores. Participants were summarized according to the randomized study intervention. Multiple imputation was used for missing data.

Arm/Group Title	No Treatment Then JUVÉDERM® VOLUMA® XC	JUVÉDERM® VOLUMA® XC
Arm/Group Description:	Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.	Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Overall Number of Participants Analyzed	58	113
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	13.5; (4.5 to 22.5)	80.4; (72.7 to 88.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	No Treatment Then JUVÉDERM® VOLUMA® XC, JUVÉDERM® VOLUMA® XC
	Comments	JUVÉDERM® VOLUMA® XC Treatment vs No-treatment control
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	Analysis was performed using the SAS procedure MIANALYZE with normal approximation to generate an associated p-value for the comparison of responder rates between groups.
	Method	Multiple imputation regression
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Rate Difference
	Estimated Value	66.9
	Confidence Interval	(2-Sided) 95%; 54.9 to 78.8
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Number of Participants With Adverse Events
Description	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant whether or not it is related to the investigational product. The investigator assesses the relationship of each event to the use of the investigational product. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first use of the investigational product.
Time Frame	From the time of informed consent until the participant exited the study, up to 13 months after their initial/touch-up treatment, and up to 6 months after the maintenance treatment

Outcome Measure Data

Analysis Population Description

Safety population: all participants who were randomized and received study intervention (JUVÉDERM® VOLUMA® XC or no-treatment control), analyzed by treatment received

Arm/Group Title	No Treatment (Control Period)	JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period)	JUVÉDERM® VOLUMA® XC (Post-Control Period)	JUVÉDERM® VOLUMA® XC (Maintenance Period)
Arm/Group Description:	Participants who received no treatment during the first 3 months of the Control Period.	Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. They were followed up to Month 13.	Participants received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. They were followed up to Month 13.	Participants received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Overall Number of Participants Analyzed	59	112	53	40
Measure Type: Count of Participants; Unit of Measure: Participants
Any TEAE	3	38	24	13
TESAE	2	5	2	4

3. Secondary Outcome

Title	Percentage of Participants With a Score of "Improved " or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Evaluating Investigator (EI) at Month 3
Description	The Evaluating Investigator assessed the participant's temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Time Frame	Month 3 (Control Period)

Outcome Measure Data

Analysis Population Description

Modified Intent to Treat Population(mITT): all participants who were randomized and had non-missing Baseline Allergan Temple Hollowing Scale (ATHS) scores. Participants were summarized according to the randomized study intervention. Participants with analysis values at Month 3 are presented.

Arm/Group Title	No Treatment Then JUVÉDERM® VOLUMA® XC	JUVÉDERM® VOLUMA® XC
Arm/Group Description:	Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.	Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Overall Number of Participants Analyzed	56	105
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	10.7; (4.0 to 21.9)	83.8; (75.3 to 90.3)

4. Secondary Outcome

Title	Percentage of Participants With a Score of "Improved" or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Participants at Month 3
Description	Participants assessed their temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Time Frame	Month 3 (Control Period)

Outcome Measure Data

Analysis Population Description

Modified Intent to Treat Population(mITT): all participants who were randomized and had non-missing Baseline Allergan Temple Hollowing Scale (ATHS) scores. Participants were summarized according to the randomized study intervention. Participants with analysis values at Month 3 are presented.

Arm/Group Title	No Treatment Then JUVÉDERM® VOLUMA® XC	JUVÉDERM® VOLUMA® XC
Arm/Group Description:	Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.	Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Overall Number of Participants Analyzed	51	99
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	2.0; (0.0 to 10.4)	92.9; (86.0 to 97.1)

5. Secondary Outcome

Title	Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3
Description	The participants responded to each item on the FACE-Q Satisfaction with Facial Appearance questionnaire 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 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement.
Time Frame	Baseline, Month 3 (Control Period)

Outcome Measure Data

Analysis Population Description

Modified Intent to Treat Population(mITT): all participants who were randomized and had non-missing Baseline Allergan Temple Hollowing Scale (ATHS) scores. Participants were summarized according to the randomized study intervention. Overall number of participants analyzed were the participants with analysis values at both Baseline and Month 3.

Arm/Group Title	No Treatment Then JUVÉDERM® VOLUMA® XC	JUVÉDERM® VOLUMA® XC
Arm/Group Description:	Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.	Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Overall Number of Participants Analyzed	51	100
Mean (Standard Deviation); Unit of Measure: units on a scale
	-6.6 (8.90)	24.2 (22.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	JUVÉDERM® VOLUMA® XC
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean satisfaction score at Month 3 visit is statistically greater than at Baseline for the treatment group.
	Method	t-test, 2 sided
	Comments	[Not Specified]

6. Secondary Outcome

Title	Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire
Description	The participants responded to each item on the FACE-Q Satisfaction with Temples questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement.
Time Frame	Baseline, Month 3 (Control Period)

Outcome Measure Data

Analysis Population Description

Modified Intent to Treat Population(mITT): all participants who were randomized and had non-missing Baseline Allergan Temple Hollowing Scale (ATHS) scores. Participants were summarized according to the randomized study intervention. Overall number of participants analyzed were the participants with analysis values at both Baseline and Month 3.

Arm/Group Title	No Treatment Then JUVÉDERM® VOLUMA® XC	JUVÉDERM® VOLUMA® XC
Arm/Group Description:	Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.	Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Overall Number of Participants Analyzed	51	100
Mean (Standard Deviation); Unit of Measure: units on a scale
	-4.2 (14.77)	42.7 (26.65)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	JUVÉDERM® VOLUMA® XC
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean satisfaction score at Month 3 is statistically greater than at Baseline for the treatment group.
	Method	t-test, 2 sided
	Comments	[Not Specified]

Adverse Events

Time Frame	No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6
Adverse Event Reporting Description	Safety population: all participants who were randomized and received study intervention, analyzed by treatment received
Arm/Group Title	No Treatment (Control Period)		JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period)		JUVÉDERM® VOLUMA® XC (Post-Control Period)		JUVÉDERM® VOLUMA® XC (Maintenance Period)
Arm/Group Description	Participants who received no treatment during the first 3 months of the Control Period.		Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. They were followed up to Month 13.		Participants randomized to no treatment during the first 3 months of the Control Period who then received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. They were followed up to Month 13.		Participants randomized to JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period who then received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
All-Cause Mortality
	No Treatment (Control Period)		JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period)		JUVÉDERM® VOLUMA® XC (Post-Control Period)		JUVÉDERM® VOLUMA® XC (Maintenance Period)
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/59 (0.00%)		0/112 (0.00%)		0/53 (0.00%)		0/40 (0.00%)
Serious Adverse Events
	No Treatment (Control Period)		JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period)		JUVÉDERM® VOLUMA® XC (Post-Control Period)		JUVÉDERM® VOLUMA® XC (Maintenance Period)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/59 (3.39%)		5/112 (4.46%)		2/53 (3.77%)		4/40 (10.00%)
Infections and infestations
LOCALISED INFECTION † 1	0/59 (0.00%)	0	1/112 (0.89%)	1	0/53 (0.00%)	0	0/40 (0.00%)	0
LYME DISEASE † 1	0/59 (0.00%)	0	1/112 (0.89%)	1	0/53 (0.00%)	0	0/40 (0.00%)	0
SINUSITIS † 1	0/59 (0.00%)	0	1/112 (0.89%)	1	0/53 (0.00%)	0	2/40 (5.00%)	2
STAPHYLOCOCCAL SKIN INFECTION † 1	0/59 (0.00%)	0	1/112 (0.89%)	1	0/53 (0.00%)	0	0/40 (0.00%)	0
TOOTH INFECTION † 1	1/59 (1.69%)	1	0/112 (0.00%)	0	0/53 (0.00%)	0	0/40 (0.00%)	0
URINARY TRACT INFECTION † 1	0/59 (0.00%)	0	1/112 (0.89%)	1	0/53 (0.00%)	0	0/40 (0.00%)	0
Injury, poisoning and procedural complications
RADIUS FRACTURE † 1	0/59 (0.00%)	0	0/112 (0.00%)	0	0/53 (0.00%)	0	1/40 (2.50%)	1
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DEGENERATION † 1	0/59 (0.00%)	0	0/112 (0.00%)	0	0/53 (0.00%)	0	1/40 (2.50%)	1
LUMBAR SPINAL STENOSIS † 1	1/59 (1.69%)	1	0/112 (0.00%)	0	0/53 (0.00%)	0	0/40 (0.00%)	0
SYSTEMIC LUPUS ERYTHEMATOSUS † 1	0/59 (0.00%)	0	0/112 (0.00%)	0	1/53 (1.89%)	1	0/40 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA † 1	0/59 (0.00%)	0	0/112 (0.00%)	0	1/53 (1.89%)	1	0/40 (0.00%)	0
Reproductive system and breast disorders
ENDOMETRIAL HYPERPLASIA † 1	0/59 (0.00%)	0	1/112 (0.89%)	1	0/53 (0.00%)	0	0/40 (0.00%)	0
1 Term from vocabulary, MedDRA 25.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	No Treatment (Control Period)		JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period)		JUVÉDERM® VOLUMA® XC (Post-Control Period)		JUVÉDERM® VOLUMA® XC (Maintenance Period)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0.00%)		19/112 (16.96%)		16/53 (30.19%)		5/40 (12.50%)
Infections and infestations
COVID-19 † 1	0/59 (0.00%)	0	3/112 (2.68%)	3	1/53 (1.89%)	1	2/40 (5.00%)	2
Musculoskeletal and connective tissue disorders
PAIN IN JAW † 1	0/59 (0.00%)	0	6/112 (5.36%)	11	7/53 (13.21%)	9	1/40 (2.50%)	2
TRISMUS † 1	0/59 (0.00%)	0	2/112 (1.79%)	2	2/53 (3.77%)	3	2/40 (5.00%)	3
Nervous system disorders
HEADACHE † 1	0/59 (0.00%)	0	9/112 (8.04%)	10	9/53 (16.98%)	10	1/40 (2.50%)	1
1 Term from vocabulary, MedDRA 25.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.

Results Point of Contact

• Name/Title: Global Medical Services
• Organization: AbbVie
• Phone: 800-633-9110
• EMail: abbvieclinicaltrials@abbvie.com

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT04414397
• Other Study ID Numbers: 1878-702-008
• First Submitted: May 29, 2020
• First Posted: June 4, 2020
• Results First Submitted: March 29, 2024
• Results First Posted: April 25, 2024
• Last Update Posted: April 25, 2024