Study to Evaluate the Effectiveness, Safety and Long Term Safety of Saypha® FILLER Lidocaine for Lip Augmentation

NCT04917588 | Completed Results

• 1 other identifier: CPH-101-201479
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 3

Brief Summary

This is a prospective, open-label, multicentre, randomized study conducted to evaluate the effectiveness, safety and long-term safety of Saypha® FILLER Lidocaine for lip augmentation.

Conditions

Abnormal Lip

Keywords

Moderate to Severe Lip Volume Deficit

Outcome Measures

Primary Outcomes (1)

• Responder Rate in Lip Volume Improvement

  The proportion of subjects ('responders') with the lip volume improved by ≥1 point versus baseline value at 6 weeks after initial treatment based on the investigator live assessment using the validated Lip Fullness Scale (LFS). Lip Fullness Scale (LFS) is a validated 5-point rating scale,that evaluates the Lip Volume Deficiency ranging from Grade 1 (minimal volume) to Grade 5 (very significant volume): In this case, the bigger the number, the better.

  Week 6

Secondary Outcomes (9)

• Percentage of Responders Based on the Investigator Live Assessment

  6, 12 and optional 18 months

• Percentage of Responders Based on the Independent Photographic Reviewer´s Assessments

  Week 6, Month 6, 12 and optional Month 18

• Percentage of Subjects With an Improvement Based on the Investigator Assessment Using GAIS

  Week 6, Month 6, 12 and optional Month 18

• Percentage of Subjects With an Improvement Based on Subject Assessment Using GAIS

  Week 6, Month 6, 12 and optional Month 18

• Subject Satisfaction Using Face-Q Questionnaire

  Week 6, Month 6, 12 and optional Month 18

Study Arms (2)

Saypha® FILLER HQ

EXPERIMENTAL

Eligible subjects will undergo bilateral lip augmentation treatments with Saypha® FILLER Lidocaine manufactured in the Croma Pharma HQ Facility in order to correct moderate to severe deficiency of lip volume. The treatment will be administered at the Baseline visit (Day 0).

Combination Product: Saypha® FILLER Lidocaine (HQ)

Saypha® FILLER C1

ACTIVE COMPARATOR

Eligible subjects will undergo bilateral lip augmentation treatments with Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility in order to correct moderate to severe deficiency of lip volume. The treatment will be administered at the Baseline visit (Day 0).

Combination Product: Saypha® FILLER Lidocaine (C1)

Interventions

Saypha® FILLER Lidocaine (HQ) COMBINATION_PRODUCT

Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year.

Saypha® FILLER HQ

Saypha® FILLER Lidocaine (C1) COMBINATION_PRODUCT

Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year.

Saypha® FILLER C1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult female or male subjects 18 years of age at Screening/Baseline visit (Visit 1)
• Presence of approximately symmetrical "very thin" lips (minimal red lip shows) to "moderately thick" lips (moderate red lip shows) as assessed with the LFS (severity grade of 1 to 3 on both lips) as determined by the investigator at Visit 1
• For females of childbearing potential only: negative urine pregnancy test at Visit 1, and must agree to use an highly effective method of contraception for the duration of the clinical investigation
• Healthy skin in the treatment area and free of diseases that could interfere in evaluation of treatment
• Willingness to abstain from any cosmetic or surgical procedures in the treatment area for the duration of the clinical investigation
• Willingness to take part in this clinical investigation documented by a personally signed/dated informed consent.

You may not qualify if:

• 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
• Prior surgery, scars or tattoo to the upper or lower lip or lip line; surgery and tattooing are prohibited until end of clinical investigation
• Tooth gap, overbite, beard longer three-day beard, or excessive facial hair that could interfere in evaluation of treatment as judged by the investigator
• Presence of any abnormal lip structure, such as a scar or lump or severe lip asymmetry, as judged by the investigator
• Previous tissue augmenting therapy in the lip area (including lips, oral commissures, nasolabial folds, marionette and perioral lines) with HA or collagen filler, or laser treatment, chemical peeling, dermabrasion or mesotherapy within 12 months before Visit 1 and until end of clinical investigation
• Previous permanent implant or treatment with non-HA or non-collagen filler in the lip area (including lips, oral commissures, nasolabial folds, marionette and perioral lines) and until end of the investigation
• Previous toxin treatment in the lip area (including lips, oral commissures, nasolabial folds, marionette and perioral lines) within 9 months before Visit 1 and until end of clinical investigation
• Presence of cutaneous lesions, inflammatory and/or infectious processes (e.g. acne, herpes, etc.) or proliferative 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, keloid formation and/or pigmentation disorders
• History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
• Uncontrolled systemic diseases (such as diabetes mellitus)

Sponsors & Collaborators

• Croma-Pharma GmbH: lead

Study Sites (3)

Medizinisch Aesthetisches Zentrum Wien

Vienna, 1010, Austria

Location

YUVELL - Home of Aesthetics

Vienna, 1010, Austria

Location

PW-Privatklinik Waehring GmbH

Vienna, 1180, Austria

Location

Results Point of Contact

• Title: Head of Clinical Operations
• Organization: CROMA - PHARMA

clinical.studies@croma.at

+43 0226268468

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 8, 2021
• Study Start: July 28, 2020
• Primary Completion: December 14, 2020
• Study Completion: April 6, 2022
• Last Updated: March 14, 2025
• Results First Posted: March 14, 2025

Record last verified: 2022-05

Locations

AU (3)