Restylane Defyne in a Stepwise Treatment Approach

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04520997
• Collaborator: (none)
• Enrollment: 60
• Locations: 5
• Arms: 2
• Actual Duration (Months): 9.1
• Patients Per Site: 12
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

This is 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.

Condition or Disease	Intervention/Treatment	Phase
Lower Face Folds and Lines	Device: Restylane Defyne	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Evaluator-Blinded Study to Evaluate Facial Harmony and Subject Satisfaction Using Restylane Defyne in a Stepwise Treatment Approach
• Actual Study Start Date: Dec 7, 2020
• Actual Primary Completion Date: Sep 10, 2021
• Actual Study Completion Date: Sep 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Down-up Participants in this group will receive injections in the chin area at baseline and in the nasolabial folds (NLFs) and marionette lines (MLs) at week 3.	Device: Restylane Defyne; Hyaluronic acid filler
Experimental: Top-down Participants in this group will receive injections in the nasolabial folds (NLFs) and marionette lines (MLs) at baseline and in the chin area at week 3.	Device: Restylane Defyne; Hyaluronic acid filler

Outcome Measures

Primary Outcome Measures

1. Percentage of participants assessed as at least improved on the GAIS [Week 3, 6 and 9]

   Aesthetic improvement after treatment in chin and nasolabial fold/marionette line, respectively, and in combination is evaluated by Treating Investigator. Aesthetic improvement is evaluated with the 5-graded Global Aesthetic Improvement Scale (GAIS) with options 'worse', 'no change', 'improved', 'much improved', 'very much improved'.

Secondary Outcome Measures

1. Percentage of participants assessed as having a natural treatment result [Week 3, 6 and 9]

   To evaluate naturalness of the treatment result, assessed by Treating Investigator using directed questions.

2. Percentage of participants agreeing with statements in a satisfaction questionnare [Week 3, 6 and 9]

   Subject satisfaction treating chin versus treating nasolabial fold/marionette line, respectively, and in combination, is evaluated. Evaluation made via subject satisfaction questionnaire.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects willing to comply with the requirements of the study and providing a signed written informed consent

• Subjects willing 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

Exclusion Criteria:

• 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

• Previous use of any semi-permanent treatment (e.g., calcium hydroxylapatite or Poly-L-Lactic acid) below the level of the horizontal line from the lower orbital rim within 24 months of the baseline visit

• Previous use of any HA based or collagen based biodegradable facial tissue augmentation therapy below the level of the horizontal line from the lower orbital rim within 12 months of the baseline visit

• Previous facial surgery, within 12 months, below the level of the horizontal line from the lower orbital rim

• Participation in any interventional clinical study within 30 days of screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Galderma Research Site	Birmingham	Alabama	United States	35209
2	Galderma Research Site	Chicago	Illinois	United States	60611
3	Galderma Research Site	Belo Horizonte		Brazil
4	Galderma Research Site	São Paulo		Brazil
5	Galderma Research Site	Palermo		Italy

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Q-Med AB, Galderma R&D

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT04520997
• Other Study ID Numbers: 05DF1910
• First Posted: Aug 20, 2020
• Last Update Posted: Aug 25, 2022
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Aug 25, 2022