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

NCT06509477 | Completed Results

• 1 other identifier: LUN.ESP.KB.IV.00
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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 prominent with aging and significantly affects the beauty of the facial skin. Dermal fillers, particularly hyaluronic acid (HA) fillers, are commonly used to correct these signs of aging. This study aimed to compare the effectiveness and safety of Lunaphil Ultra with Juvederm Ultra 4® for treating NLFs. Primary objective: Effectiveness assessment of Lunaphil Ultra Secondary objectives: Effectiveness and safety assessment of Lunaphil Ultra Study design: This is a randomized, double-masked, active controlled, within-subject, and equivalency clinical trial. Setting: Subjects were treated with Lunaphil Ultra in one NLF and Juvederm Ultra 4® in the opposite NLF.

Conditions

Moderate or Severe Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

• Mean Level of Improvement From Baseline in NLF Severity Score by Wrinkle Severity Rating Scale (WSRS)

  The scores are from 1 to 5, 1 indicating no visible folds and 5 indicating extreme folds

  24 weeks

Secondary Outcomes (5)

• Number of Subjects With an Improved Score From Baseline Based on Physician Global Aesthetic Improvement Scale (PGAIS)

  24 weeks

• Number of NLFs Maintaining a Clinically Significant Improvement in NLF Severity Score by Wrinkle Severity Rating Scale (WSRS)

  24 weeks

• The Injected Volume to Obtain Optimal Aesthetic Result

  2 weeks

• The Number of NLFs Receiving Touch-up Treatment

  2 weeks

• Evaluation of Adverse Events During 24 Weeks

  24 weeks

Study Arms (2)

Lunaphil Ultra (by Espad Pharmed Co.)

EXPERIMENTAL

Lunaphil Ultra (by Espad Pharmed Co.) will be administered over a 2-week period (initial treatment plus one touch-up) to achieve optimal correction of the NLFs. In case of suboptimal correction of NLFs at week 2 after the initial treatment, the treating investigator will be directed to retreat the under corrected NLF(s).

Device: Hyaluronic acid Lunaphil Ultra (by Espad Pharmed Co.)

Juvederm Ultra 4® (by Allergan Co.)

ACTIVE COMPARATOR

Juvederm Ultra 4® (by Allergan Co.) will be administered over a 2-week period (initial treatment plus one touch-up) to achieve optimal correction of the NLFs. In case of suboptimal correction of NLFs at week 2 after the initial treatment, the treating investigator will be directed to retreat the under corrected NLF(s).

Device: Hyaluronic acid Juvederm Ultra 4® (by Allergan Co.)

Interventions

Hyaluronic acid Juvederm Ultra 4® (by Allergan Co.) DEVICE

Two treatments will be allowed over a 2-week period (initial treatment plus one touch-up) to achieve optimal correction of the NLFs based on investigator's opinion

Juvederm Ultra 4® (by Allergan Co.)

Hyaluronic acid Lunaphil Ultra (by Espad Pharmed Co.) DEVICE

Two treatments will be allowed over a 2-week period (initial treatment plus one touch-up) to achieve optimal correction of the NLFs based on investigator's opinion

Lunaphil Ultra (by Espad Pharmed Co.)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Espad Pharmed: lead

Study Sites (1)

Orchid Pharmed, Medical Department

Tehran, 19947-66411, Iran

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Hamidreza Kafi
• Organization: EspadPharmed

Kafi.h@orchidpharmed.com

+989129232594

Study Officials

• Kamran Balighi, Prof. Derm

  Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-masked, active controlled, within-subject, paired, and equivalency clinical trial. Subjects were treated with Lunaphil Ultra in one NLF and Juvederm Ultra 4® in the opposite NLF.

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 19, 2024
• Study Start: December 1, 2021
• Primary Completion: November 11, 2023
• Study Completion: November 11, 2023
• Last Updated: February 3, 2026
• Results First Posted: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)