Effectiveness and Safety of Princess FILLER Lidocaine in Correction of Nasolabial Folds (NLF)

Dermatological Non-Disease Clinical Trial

— FILIDO  

Official title:

A Randomized, Subject- and Evaluating Investigator-blinded, Controlled, Multicenter, Split-face, Comparison Clinical Investigation to Evaluate Effectiveness and Safety of Princess FILLER Lidocaine in the Correction of Nasolabial Folds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03990883
• Other study ID #: CPH 301-201200F
• Status: Completed
• Phase: N/A
• Start date: June 4, 2019
• Est. completion date: February 15, 2022

Study information

• Verified date: March 2022
• Source: Croma-Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical Investigation to demonstrate the effectiveness and safety of Princess Filler Lidocaine in the correction of moderate to severe nasolabial folds

Description:

Clinical Investigation to assess the effectiveness of "Princess Filler Lidocaine" in reducing the severity of nasolabial folds compared to "Juvederm Ultra XC", based on the independent blinded evaluating investigator live assessment using the Nasolabial Folds Severity Rating Scale (NLF-SRS) at Week 24 after initial treatment and relative to Baseline assessments

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: February 15, 2022
• Est. primary completion date: May 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• over or equal 22 years at screening

• approximately symmetrical moderate to severe nasolabial folds

• negative urine pregnancy test

• healthy skin

• willing to abstain from aesthetic or surgical procedures in the treatment area

• written informed consent

Exclusion Criteria:

• pregnant and/or lactating

• history of allergies or hypersensitivity to e.g. hyaluronic acid preparations

• tendency to keloid formation

• HIV positive

• presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions

• herpes simplex in treatment area

• autoimmune or connective tissue disease, immunomodulating therapy

• uncontrolled diabetes or systemic diseases

• Facial plastic surgery, tissue augmentation

• implantation of facial dermal fillers within 12 months

• Skin of nasolabial region affected by aesthetic treatments

• Facial lipolysis

• Bariatric surgery within 12 months

• History of bleeding disorder

• Planned dental/oral surgery

• Any medical condition prohibiting the inclusion according to the investigator

• Previous enrollment

• Current participation in another clinical investigation within 30 days prior to enrollment

• Dependency of the subject to the investigation site

Related Conditions & MeSH terms

• Dermatological Non-Disease

Intervention

Device:
• Princess Filler Lidocaine
correction of nasolabial folds

Locations

Country	Name	City	State
United States	John Joseph	Beverly Hills	California
United States	Gary Monheit	Birmingham	Alabama
United States	Jeremy Green	Coral Gables	Florida
United States	Joel Cohen	Greenwood Village	Colorado
United States	Robert Weiss	Hunt Valley	Maryland
United States	Jeanine Downie	Montclair	New Jersey
United States	Michael Gold	Nashville	Tennessee
United States	The Center for Dermatology Cosmetic and Laser Surgery	New York	New York
United States	Susan Taylor	Philadelphia	Pennsylvania
United States	Sabrina Fabi	San Diego	California
United States	Ava Shamban	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Croma-Pharma GmbH	Syneos Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	independent evaluating investigator live assessment	percentage of responders based on the independent evaluating investigators live assessment	Week 24
Secondary	independent photographic reviewers assessment	percentage of responders based on the independent photographic reviewers assessment	Week 24
Secondary	treating investigator live assessment	percentage of responders based on the treating investigators live assessment	Week 24
Secondary	Improvement over Baseline - investigator assessment	percentage of subjects with improvement based on the independent evaluating investigators assessment	Week 24
Secondary	Improvement over Baseline - subject assessment	percentage of subjects with improvement based on the subjects assessment	Week 24