JUVEDERM® Ultra XC vs. Belotero Balance® for Perioral Lines

NCT ID: NCT01970397

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-21
• Study Completion Date: 2014-08-04

Brief Summary

A prospective, randomized, controlled, multi-center study of the safety and effectiveness of JUVEDERM® Ultra XC injectable gel versus Belotero Balance® for perioral lines

Conditions

Patients With Moderate to Severe Perioral Lines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

JUVEDERM® Ultra XC

Perioral lines treated with JUVEDERM® Ultra XC

Group Type: EXPERIMENTAL

JUVEDERM® Ultra XC

Intervention Type: DEVICE

Up to 3.0 mLs JUVEDERM® Ultra XC injected into the mid to deep dermis (2.0 mLs for initial treatment and 1.0 mL for touch-up treatment).

Belotero Balance®

Perioral Lines treated with Belotero Balance®

Group Type: EXPERIMENTAL

Belotero Balance®

Intervention Type: DEVICE

Up to 3.0 mLs Belotero Balance® injected into the mid to deep dermis (2.0 mLs for initial treatment and 1.0 mL for touch-up treatment).

Interventions

JUVEDERM® Ultra XC

Up to 3.0 mLs JUVEDERM® Ultra XC injected into the mid to deep dermis (2.0 mLs for initial treatment and 1.0 mL for touch-up treatment).

Intervention Type: DEVICE

Belotero Balance®

Up to 3.0 mLs Belotero Balance® injected into the mid to deep dermis (2.0 mLs for initial treatment and 1.0 mL for touch-up treatment).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Have moderate to severe perioral lines as assessed by the Investigator using the 4-point POLSS (none, mild, moderate, and severe)
• Accept the obligation not to receive any other facial procedures or treatments at any time during the study that are not study related

Exclusion Criteria

• Have lip tattoos, facial hair or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments
• Have dentures or any device covering all or part of the upper palate, and/or severe malocclusion, dentofacial or maxillofacial deformities, or significant asymmetry of the perioral area, as judged by the Treating Investigator
• Have a history of skin cancer
• Is an active smoker
• Has noticeable acne scarring, active inflammation, infection, cancerous or precancerous lesion, or unhealed wound in the mouth area
• Have had an active oral herpes or cold sore within 12 months
• Have undergone oral surgery or other dental procedures (e.g., tooth extraction, orthodontia, or implantation) within 30 days prior to enrollment or be planning to undergo any of these procedures during the study
• Have undergone cosmetic facial or perioral area procedures [e.g., face-lift, or other surgeries which may alter the appearance of the perioral area, including tissue grafting, or tissue augmentation with silicone, fat, or other permanent fillers] or be planning to undergo any of these procedures at any time during the study
• Have undergone temporary or semi-permanent facial dermal filler injections (e.g., hyaluronic acid, calcium hydroxylapatite, L-Polylactic acid) in the lower face (below the orbital rim) within 24 months
• Have received mesotherapy, or resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study other than study related procedures.
• Have begun use of any new over-the-counter or prescription, oral or topical, antiwrinkle products in the treatment area within 90 days prior to enrollment or be planning to begin use of such products at any time during the study. [NOTE: Use of sunscreens and continued therapy with some cosmeceuticals (e.g., alpha hydroxyl acids, glycolic acids, retinol, or retinoic acids) is allowed if the regimen was established ≥ 90 days prior to enrollment]
• Have had epilation (e.g. laser hair removal, electrolysis, threading, etc.) in the perioral area performed within 3 months
• Have received treatment with botulinum toxin of any serotype for any indication in the lower face [below the infraorbital rims (IORs)] within 1 year of the baseline visit

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

Chapel Hill, North Carolina, United States

Countries

United States

References

Butterwick K, Marmur E, Narurkar V, Cox SE, Joseph JH, Sadick NS, Tedaldi R, Wheeler S, Kolodziejczyk JK, Gallagher CJ. HYC-24L Demonstrates Greater Effectiveness With Less Pain Than CPM-22.5 for Treatment of Perioral Lines in a Randomized Controlled Trial. Dermatol Surg. 2015 Dec;41(12):1351-60. doi: 10.1097/DSS.0000000000000576.

Reference Type: BACKGROUND

PMID: 26606435 (View on PubMed)

Other Identifiers

GMA-JUV13001

Identifier Type: -

Identifier Source: org_study_id