Saypha® Volume LIdocaine in Nasolabial Folds

NCT04883632 | Completed Results

• 1 other identifier: CPH-101-201477
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

Brief Summary

Comparison of saypha Volume Lidocaine from 2 different manufacturing locations in correcting moderate to sever nasolabial folds

Conditions

Moderate to Severe Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

• Responder Rate in Reduction of Nasolabial Folds

  The proportion of subjects with the NLF-SRS grade reduced by ≥1 point versus baseline at Week 24. This anaylsis is done per manufacturing site: C1 and HQ separately and for the overall population. A 'responder' is defined having at least ≥ 1 grade improvement as evaluated with the 5 point-validated NLF-SRS score on both sides of the face. Nasolabial Folds Severity Rating Scale (NLF-SRS) is a validated 5 grade scale where the lower number corresponds to: 0 = None/minimal: No visible/minimal nasolabial folds; 1. = Mild: Shallow but visible nasolabial fold with a slight indentation; 2. = Moderate: Moderately deep nasolabial fold; 3. = Severe: Very deep nasolabial fold with prominent facial feature; 4. = Extreme: Extremely deep and long nasolabial fold with skin redundancy Therefore, the lower the number, the better.

  24 Weeks

Secondary Outcomes (2)

• Proportion of Responders at Other Time Points

  Week 4, week 36, week 52, week 65, week 78, week 104

• Change Versus Baseline in Nasolabial Fold Severitry

  Week 4, Week 24, Week 36, Week 52 and, optional at Week 65, Week 78 and Week 104

Other Outcomes (10)

• Percentage of Responders With a ≥2-point Improvement

  Weeks 4, 24, 36, 52, 65, 78, and 104

• Percentage of Subjects With Aesthetic Improvement Using the 5-point GAIS Based on Investigator's Assessment

  Weeks 4, 24, 36, 52, 65, 78, and 104

• Percentage of Subjects With Aesthetic Improvement Using the 5-point GAIS Based on Subjects Assessment

  Weeks 4, 24, 36, 52, 65, 78, and 104

Study Arms (2)

Volume Lidocaine HQ

EXPERIMENTAL

Subjects randomized to be treated with Saypha Volume Lidocaine manufactured in the Croma Pharma HQ Facility

Combination Product: Saypha Volume Lidocaine

Volume Lidocaine C1

ACTIVE COMPARATOR

Subjects randomized to be treated with Saypha Volume Lidocaine manufactured in the Croma Pharma C1 Facility

Combination Product: Saypha Volume Lidocaine

Interventions

Saypha Volume Lidocaine COMBINATION_PRODUCT

correction of Nasolabial Folds using injection of Saypha Volume Lidocaine manufactured in 2 different plants at Croma Pharma. The amount injected depended on the size of the area to be corrected and the desired level of soft tissue augmentation. It was estimated that a maximum volume of 4 mL per treatment was needed but should not have exceeded 10 mL in total per treatment or 20 mL per year. and use in respective indications. The investigational device was administered to eligible subjects on investigation Day 0. A touchup treatment at Week 2 was optional at the investigator's discretion if full correction was

Volume Lidocaine C1; Volume Lidocaine HQ

Eligibility Criteria

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

You may qualify if:

• A subject must meet ALL of the following criteria to be eligible for the study:
• Male or female 18 years of age or older
• Presence of two fully visible, approximately symmetrical nasolabial folds, with each of the folds scored with 2 or 3 according to the 5-grade Nasolabial Folds Severity Rating Scale (NLF-SRS) as assessed by the investigator
• Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation
• Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation
• Written signed and dated informed consent

You may not qualify if:

• subject who meets ANY of the following criteria is NOT eligible for the study:
• Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only)
• History of mental disorders or emotional instability
• History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anaesthetic
• Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region
• Any superficial or deep facial surgery or injection or implantation of any dermal fillers (including but not limited to hyaluronic acid, collagen, calcium hydroxylapatite, poly-l-lactic acid, polymethylmethacrylate, autologous fat injections), application of any absorbable and non-absorbable sutures (thread) for any purpose including wound care and facial lifting, any laser therapy (including but not limited to Neodym-YAG, KTP, IPL, Diode lasers as well as Erbium-YAG, CO2 or other ablative lasers), dermoabrasion, or botulinum toxin application in the nasolabial region within previous 12 months prior to enrolment, or any chemical peeling procedures (including but not limited to glycolic acid, trichloroacetic acid or phenolic peels) within previous 3 months prior to enrolment, or planning to undergo such procedures in the treatment area during the study
• Presence of infectious, inflammatory, or proliferative lesions in the nasolabial region
• Cutaneous lesions in the treatment area
• Known human immune deficiency virus-positive individuals
• History of allergies against aesthetic filling products and recurrent (3 times a year) herpes simplex in the treated area
• Tendency to hypertrophic scars and/or keloid formation
• History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
• Uncontrolled systemic diseases (such as diabetes mellitus)
• Bariatric surgery within 12 months prior to enrollment or planned during the clinical investigation
• Use of anticoagulant or thrombolytic medication from 10 days pre- to 3 days post injection

Sponsors & Collaborators

• Croma-Pharma GmbH: lead

Study Sites (3)

Yuvell

Vienna, 1010, Austria

Location

Ordination Dr. Gaerner

Vienna, 1180, Austria

Location

Privatklinik Waehring GmbH

Vienna, 1180, Austria

Location

Results Point of Contact

• Title: Clinical Development - Head of Clinical Operations
• Organization: Croma Pharma

clinical.studies@croma.at

+432262684680

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will be randomized to receive products from one of 2 productions sites. (C1 and HQ, respectively); as the products appear in an identical fashion only the batch numbers will allow identification of the production site; as the allocation of batch numbers to the respective site is not disclosed to the study site team, the entire team will be masked until break of blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, randomized, double-blind, parallel-group, multi-center study

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 12, 2021
• Study Start: November 5, 2019
• Primary Completion: May 27, 2021
• Study Completion: February 16, 2022
• Last Updated: April 3, 2025
• Results First Posted: April 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)