A Safety and Effectiveness Study of JUVÉDERM VOLIFT® XC Versus Control for Moderate to Severe Nasolabial Folds

Moderate to Severe Nasolabial Folds Clinical Trial

Official title:

A Prospective, Multicenter, Within-subject Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLIFT® XC Versus Control for the Correction of Moderate to Severe Nasolabial Folds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01976663
• Other study ID #: S17L-001
• Status: Completed
• Phase: N/A
• Start date: October 29, 2013
• Est. completion date: October 26, 2015

Study information

• Verified date: March 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective, multicenter, within-subject controlled study of the safety and effectiveness of JUVÉDERM VOLIFT® XC versus Control for the correction of moderate to severe nasolabial folds (NLFs).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 26, 2015
• Est. primary completion date: March 17, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 2 visible moderate to severe nasolabial folds

• Agree to refrain from undergoing other anti-wrinkle/volumizing treatments in the lower two-thirds of the face for the duration of the study

Exclusion Criteria:

• Undergone facial tissue augmentation with dermal fillers in the lower two-thirds of the face within the past 12 months

• Undergone facial tissue augmentation with fat injections, botulinum toxin injections in the lower two-thirds of the face, mesotherapy, or cosmetic facial procedures in the face or neck within the past 6 months

• Received semi-permanent fillers or permanent facial implants anywhere in the lower face

Related Conditions & MeSH terms

• Moderate to Severe Nasolabial Folds

Intervention

Device:
• JUVEDERM VOLIFT® XC
Up to 4 mLs JUVEDERM VOLIFT® XC injected intradermally in one NLF (total; including initial and touch-up treatments) and up to 4 mLs JUVEDERM VOLIFT XC is allowed for repeat treatment. For asymmetric correction, only the more severe NLF is eligible for asymmetric correction.
• Control
Up to 4 mLs Control injected intradermally in opposite NLF (total; including initial and touch-up treatments). Up to 4 mLs JUVEDERM VOLIFT XC is allowed for asymmetry correction and up to 4 mLs JUVEDERM VOLIFT XC is allowed for repeat treatment. Only the more severe NLF is eligible for asymmetric correction.

Locations

Country	Name	City	State
United States	Total Skin and Beauty Dermatology Center P.C.	Birmingham	Alabama
United States	Dermatology Research Institute, LLC	Coral Gables	Florida
United States	Skin Research Institute	Coral Gables	Florida
United States	Vitiligo and Pigmentation Institute of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

References & Publications (1)

Monheit G, Beer K, Hardas B, Grimes PE, Weichman BM, Lin V, Murphy DK. Safety and Effectiveness of the Hyaluronic Acid Dermal Filler VYC-17.5L for Nasolabial Folds: Results of a Randomized, Controlled Study. Dermatol Surg. 2018 May;44(5):670-678. doi: 10.1097/DSS.0000000000001529. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS)	Nasolabial fold severity is assessed by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). Mean change from baseline in NFLSS is defined as score at baseline minus score at Month 6. A negative number change from baseline indicated improvement and a positive number change from baseline indicated worsening.	Baseline, Month 6
Primary	Percentage of Nasolabial Folds With =1-Point Improvement	Nasolabial fold severity is evaluated by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). The percentage of nasolabial folds with =1-point improvement from baseline (i.e., decrease in severity) are reported.	Baseline, Month 6
Secondary	Percentage of Nasolabial Folds With =1-Point Improvement	Nasolabial fold severity is evaluated by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). The percentage of nasolabial folds with =1-point improvement from baseline (i.e., decrease in severity) are reported.	Baseline, Month 12
Secondary	Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score	Subjects evaluate nasolabial folds on the 5-item Nasolabial Folds module of the FACE-Q questionnaire. Responses to the 5 items are combined to create a scale score that ranged from 0 to 100, where 0 indicates that the subject is extremely bothered and 100 indicates that the subject is not all bothered by the appearance of the nasolabial fold. Change from baseline is defined as the score at Month 12 minus the baseline score. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.	Baseline, Month 12