Restylane Defyne in a Stepwise Treatment Approach

NCT04520997 | Completed Results FDA Device

• 1 other identifier: 05DF1910
• Study Type: interventional
• Target: 62
• Locations: 3 countries
• Sites: 5

Brief Summary

This was a 12-week study to evaluate the effectiveness and safety of Restylane Defyne when using two different injection approaches, stepwise down-up vs. top-down, when treating the lower face.

Conditions

Lower Face Folds and Lines

Outcome Measures

Primary Outcomes (3)

• Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3

  Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 3 were reported.

  At Week 3

• Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6

  Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the Treating Investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Percentage of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 6 were reported.

  At Week 6

• Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9

  Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the Treating Investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Percentage of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 9 were reported.

  At Week 9

Secondary Outcomes (2)

• Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator

  At Week 3, 6, and 9

• Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)

  At Week 3, 6 and 9

Study Arms (2)

Down-up

EXPERIMENTAL

Participants in this group received up to 2 mL Restylane Defyne on chin at baseline and up to 2 mL of Restylane Defyne per NLF at baseline and up to 2 mL per ML of Restylane Defyne at Week 3. An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator.

Device: Restylane Defyne

Top-down

EXPERIMENTAL

Participants in this group received up to 2 mL Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at baseline and up to 2mL on chin Week 3. An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator.

Device: Restylane Defyne

Interventions

Restylane Defyne DEVICE

Up to 2 milliliters (ml) of Restylane Defyne per treatment site (chin and surrounding area) with maximum of total 4 ml at baseline, up to 2 ml of Restylane Defyne per NLF and ML at week 3 and optional up to 2 ml of Restylane Defyne per facial half for NLF and ML in combination with a total of 2 ml in the chin and surrounding area at week 6.

Down-up

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects willed to comply with the requirements of the study and provided a signed written informed consent
• Subjects willed to undergo augmentation and correction therapy in the studied indications
• Adult males or non-pregnant, non-breastfeeding females and women of non-child bearing potential over the age of 21

You may not qualify if:

• Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins
• Previous use of any permanent (non-biodegradable) treatment, lifting threads, permanent implants or autologous fat below the level of the horizontal line from the lower orbital rim
• Participation in any interventional clinical study within 30 days of screening

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (5)

Galderma Research Site

Birmingham, Alabama, 35209, United States

Location

Galderma Research Site

Chicago, Illinois, 60611, United States

Location

Galderma Research Site

Belo Horizonte, Brazil

Location

Galderma Research Site

São Paulo, Brazil

Location

Galderma Research Site

Palermo, Italy

Location

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: December 7, 2020
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: April 14, 2023
• Results First Posted: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); BR (2); US (2)