Effectiveness and Safety Comparison of Lunaphil Ultra (Hyaluronic Acid, by Espad Pharmed Co.) Versus Juvederm Ultra 4® (Hyaluronic Acid, by Allergan Co.) in Nasolabial Folds (NLFs) Management

Prior treatment

• History of receiving immune therapy or a history of autoimmune disease
• Any prior cosmetic procedure or tissue augmentation at the NLF injection site within 1 year before study entry (or intent to undergo such a procedure during the study)

Other illness

• Known susceptibility to keloid formation, hypertrophic scarring or clinically significant skin pigmentation disorders
• Known sensitivity to local anesthetics of the amide type (such as lidocaine), history of hypersensitivity to gram-positive bacterial proteins, history of multiple severe allergies, history of anaphylactic shock
• Known hypersensitivity to any component of the study products or excipients (like hyaluronic acid)
• History of active chronic debilitating systemic disease
• History of connective tissue disease, history of malignancy (except for non-melanoma skin cancer) within the last 5 years
• Clinically significant active dermatologic disorders within the last 6 months

Lab values

• History of bleeding disorders or participants receiving or recently exposed (≤ 3 weeks) to continuous treatment with thrombolytics, anticoagulants, platelet inhibitors, or NSAIDs

Other

• Acute herpetic eruption
• Use of oral retinoids, over-the-counter (OTC) or prescription antiwrinkle treatments, microdermabrasion, or chemical peels in the NLF area within the last 4 weeks or intention to use them during the study
• Pregnancy or breastfeeding

• Subjects ≥ 30 years of age
• Visible bilateral NLFs that were approximately symmetrical and had an equal severity ranging from moderate to severe (assessed at the deepest part)
• Able to follow study instructions and likely to complete all required visits
• Signed informed consent