Trial Outcomes & Findings for 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 (NCT NCT06509477)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

104 participants

Primary outcome timeframe

24 weeks

Results posted on

2026-02-03

Participant Flow

Unit of analysis: NLF

Participant milestones

Participant milestones
Measure	Group 1 Each participant received Lunaphil Ultra on right NLF and Juvederm Ultra 4® on the left NLF	Group 2 Each participant received Lunaphil Ultra on left NLF and Juvederm Ultra 4® on the right NLF
Overall Study STARTED	52 104	52 104
Overall Study Lunaphil Ultra	52 52	52 52
Overall Study Juvederm Ultra 4®	52 52	52 52
Overall Study COMPLETED	51 102	46 92
Overall Study NOT COMPLETED	1 2	6 12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Participants n=104 Participants Each participant received Lunaphil Ultra on one NLF and Juvederm Ultra 4® on the other NLF
Age, Continuous	43.39 years STANDARD_DEVIATION 10.44 • n=104 Participants
Sex: Female, Male Female	83 Participants n=104 Participants
Sex: Female, Male Male	21 Participants n=104 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: 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.

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

Outcome measures

Outcome measures
Measure	Lunaphil Ultra (by Espad Pharmed Co.) n=100 Participants 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).	Juvederm Ultra 4® (by Allergan Co.) n=100 Participants 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).
Mean Level of Improvement From Baseline in NLF Severity Score by Wrinkle Severity Rating Scale (WSRS) PP population	-0.80 score on a scale Standard Deviation 0.66	-0.81 score on a scale Standard Deviation 0.67
Mean Level of Improvement From Baseline in NLF Severity Score by Wrinkle Severity Rating Scale (WSRS) ITT population	-0.73 score on a scale Standard Deviation 0.66	-0.74 score on a scale Standard Deviation 0.67

SECONDARY outcome

Timeframe: 24 weeks

Population: ITT Population; 7 participants with missing data at week 24 were excluded from the intention-to-treat (ITT) population.

The scores are from 1 to 5, 1 indicating exceptional improvement and 5 indicating worsened results

Outcome measures

Outcome measures
Measure	Lunaphil Ultra (by Espad Pharmed Co.) n=97 Participants 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).	Juvederm Ultra 4® (by Allergan Co.) n=97 Participants 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).
Number of Subjects With an Improved Score From Baseline Based on Physician Global Aesthetic Improvement Scale (PGAIS) Assessor 1	66 Participants	66 Participants
Number of Subjects With an Improved Score From Baseline Based on Physician Global Aesthetic Improvement Scale (PGAIS) Assessor 2	79 Participants	79 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: ITT population; 74 NLF in each group had 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

Outcome measures

Outcome measures
Measure	Lunaphil Ultra (by Espad Pharmed Co.) n=74 NLF 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).	Juvederm Ultra 4® (by Allergan Co.) n=74 NLF 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).
Number of NLFs Maintaining a Clinically Significant Improvement in NLF Severity Score by Wrinkle Severity Rating Scale (WSRS)	43 NLF	43 NLF

SECONDARY outcome

Timeframe: 2 weeks

Population: ITT Population

initial treatment + touch-up

Outcome measures

Outcome measures
Measure	Lunaphil Ultra (by Espad Pharmed Co.) n=104 Participants 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).	Juvederm Ultra 4® (by Allergan Co.) n=104 Participants 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).
The Injected Volume to Obtain Optimal Aesthetic Result	0.90 cc Standard Deviation 0.29	0.88 cc Standard Deviation 0.29

SECONDARY outcome

Timeframe: 2 weeks

Population: ITT population

Counting the number of NLF who need additional injection

Outcome measures

Outcome measures
Measure	Lunaphil Ultra (by Espad Pharmed Co.) n=104 NLF 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).	Juvederm Ultra 4® (by Allergan Co.) n=104 NLF 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).
The Number of NLFs Receiving Touch-up Treatment	74 NLF	69 NLF

SECONDARY outcome

Timeframe: 24 weeks

Population: Safety population

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.

Outcome measures

Outcome measures
Measure	Lunaphil Ultra (by Espad Pharmed Co.) n=104 Participants 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).	Juvederm Ultra 4® (by Allergan Co.) n=104 Participants 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).
Evaluation of Adverse Events During 24 Weeks	3 Participants	5 Participants

Adverse Events

Lunaphil Ultra (by Espad Pharmed Co.)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Juvederm Ultra 4® (by Allergan Co.)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lunaphil Ultra (by Espad Pharmed Co.) n=104 participants at risk 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	Juvederm Ultra 4® (by Allergan Co.) n=104 participants at risk 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
General disorders Injection site erythema	1.9% 2/104 • 24 weeks	0.00% 0/104 • 24 weeks
General disorders Injection site pain	0.96% 1/104 • 24 weeks	0.96% 1/104 • 24 weeks
General disorders Injection site swelling	0.96% 1/104 • 24 weeks	1.9% 2/104 • 24 weeks
General disorders Injection site mass	0.00% 0/104 • 24 weeks	0.96% 1/104 • 24 weeks
General disorders Injection site nodule	0.00% 0/104 • 24 weeks	0.96% 1/104 • 24 weeks
Nervous system disorders Presyncope	0.00% 0/104 • 24 weeks	0.96% 1/104 • 24 weeks

Additional Information

Hamidreza Kafi

EspadPharmed

Phone: +989129232594

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place