Status:
COMPLETED
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
Lead Sponsor:
Espad Pharmed
Conditions:
Moderate or Severe Nasolabial Folds
Eligibility:
All Genders
30+ years
Phase:
NA
Brief Summary
Rationale and background: Skin aging is a complex process that results in various changes in the skin, including wrinkles, sun spots, and sagging skin. The NLF is a natural change that becomes more pr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- History of bleeding disorders or participants receiving or recently exposed (≤ 3 weeks) to continuous treatment with thrombolytics, anticoagulants, platelet inhibitors, or NSAIDs
- Acute herpetic eruption
- 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 receiving immune therapy or a history of autoimmune disease
- 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
- 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
- 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)
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2023
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06509477
Start Date
December 1 2021
End Date
November 11 2023
Last Update
May 21 2025
Active Locations (1)
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1
Orchid Pharmed, Medical Department
Tehran, Tehran Province, Iran, 19947-66411