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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With an Improved Score From Baseline Based on Physician Global Aesthetic Improvement Scale (PGAIS) | The scores are from 1 to 5, 1 indicating exceptional improvement and 5 indicating worsened results | 24 weeks |
| Number of NLFs Maintaining a Clinically Significant Improvement in NLF Severity Score by Wrinkle Severity Rating Scale (WSRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamran Balighi, Prof. Derm | Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orchid Pharmed, Medical Department | Tehran | 19947-66411 | Iran |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Each participant received Lunaphil Ultra on right NLF and Juvederm Ultra 4® on the left NLF |
| FG001 | Group 2 | Each participant received Lunaphil Ultra on left NLF and Juvederm Ultra 4® on the right NLF |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 14, 2021 | Nov 5, 2025 |
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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.
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| 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 |
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≥1-point reduction from baseline. The scores are from 1 to 5, 1 indicating no visible folds and 5 indicating extreme folds |
| 24 weeks |
| The Injected Volume to Obtain Optimal Aesthetic Result | initial treatment + touch-up | 2 weeks |
| The Number of NLFs Receiving Touch-up Treatment | Counting the number of NLF who need additional injection | 2 weeks |
| Evaluation of Adverse Events During 24 Weeks | All reported AEs are classified based on the Medical Dictionary for Regulatory Activities (MedDRA) terms and are graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | 24 weeks |
| Lunaphil Ultra |
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| Juvederm Ultra 4® |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Participants | Each participant received Lunaphil Ultra on one NLF and Juvederm Ultra 4® on the other NLF |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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 | 29 participants were excluded from the per-protocol (PP) population due to protocol violation; In addition, 4 participants with missing data at week 24 and 4 participants with missing data at week 12 (for imputation) were excluded from the intention-to-treat (ITT) population. | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
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| Secondary | Number of Subjects With an Improved Score From Baseline Based on Physician Global Aesthetic Improvement Scale (PGAIS) | The scores are from 1 to 5, 1 indicating exceptional improvement and 5 indicating worsened results | ITT Population; 7 participants with missing data at week 24 were excluded from the intention-to-treat (ITT) population. | Posted | Count of Participants | Participants | 24 weeks |
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| Secondary | Number of NLFs Maintaining a Clinically Significant Improvement in NLF Severity Score by Wrinkle Severity Rating Scale (WSRS) | ≥1-point reduction from baseline. The scores are from 1 to 5, 1 indicating no visible folds and 5 indicating extreme folds | ITT population; 74 NLF in each group had clinically significant improvement in NLF severity score by Wrinkle Severity Rating Scale (WSRS) | Posted | Count of Units | NLF | 24 weeks | NLF | NLF |
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| Secondary | The Injected Volume to Obtain Optimal Aesthetic Result | initial treatment + touch-up | ITT Population | Posted | Mean | Standard Deviation | cc | 2 weeks |
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| Secondary | The Number of NLFs Receiving Touch-up Treatment | Counting the number of NLF who need additional injection | ITT population | Posted | Count of Units | NLF | 2 weeks | NLF | NLF |
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| Secondary | Evaluation of Adverse Events During 24 Weeks | All reported AEs are classified based on the Medical Dictionary for Regulatory Activities (MedDRA) terms and are graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | Safety population | Posted | Count of Participants | Participants | 24 weeks |
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24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lunaphil Ultra (by Espad Pharmed Co.) | 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). Hyaluronic acid Lunaphil Ultra (by Espad Pharmed Co.): 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 | 0 | 104 | 0 | 104 | 3 | 104 |
| EG001 | Juvederm Ultra 4® (by Allergan Co.) | 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). Hyaluronic acid Juvederm Ultra 4® (by Allergan Co.): 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 | 0 | 104 | 0 | 104 | 5 | 104 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | Systematic Assessment |
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| Injection site pain | General disorders | Systematic Assessment |
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| Injection site swelling | General disorders | Systematic Assessment |
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| Injection site mass | General disorders | Systematic Assessment |
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| Injection site nodule | General disorders | Systematic Assessment |
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| Presyncope | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hamidreza Kafi | EspadPharmed | +989129232594 | Kafi.h@orchidpharmed.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 14, 2021 | Nov 15, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ITT population |
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| >0.99 |
| Mean Difference (Final Values) |
| 0.013 |
| Standard Deviation |
| 0.11 |
| 2-Sided |
| 95 |
| -0.013 |
| 0.040 |
| Other |
| Participants |
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| NLF |
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