Non-inferiority of Belotero® Basic Versus Juvéderm® Ultra 3

Merz Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Wrinkles; Nasolabial Folds; Physiological Stress; Skin Diseases; Disorder of Aging

Treatments: Device: Hyaluronic Acid Filler

Study type: Interventional

Funder types: Industry

Identifiers

NCT01305187

MRZ 90028_4007_0

Details and patient eligibility

About

This study will investigate the non-inferiority of Belotero® Basic versus Juvéderm® Ultra 3 in the treatment of nasolabial folds

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject with bilateral, symmetrical NLF and wish for correction. Documented severity of NLF score 2 or 3 at screening on the Merz Wrinkle Severity Rating Scale II

Exclusion criteria

• Any severe or uncontrolled systemic disease (e.g. cardiac, renal, pulmonary, hepatic, or gastrointestinal). Subject suffering from diabetes mellitus, autoimmune and rheumatic diseases, clinically relevant coagulation disorders, recurrent angina, or severe psychic, neurological or mental disease
• History of malignancy within the last 5 years before the study
• Infection, inflammations or active dermatological disease in the face

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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40 participants in 1 patient group

Hyaluronic Acid Filler - Medical Device

Experimental group

Treatment:

Device: Hyaluronic Acid Filler