A Restylane Treatment Algorithm Approach for Participants With Appearance of Insufficient Bone St… (NCT06428214) | Clinical Trial Compass
CompletedNot Applicable
A Restylane Treatment Algorithm Approach for Participants With Appearance of Insufficient Bone Structure in the Lower Face Alone or in Combination With Facial Soft Tissue Deficiencies
Canada45 participantsStarted 2024-05-13
Plain-language summary
The study's main purpose is to evaluate the overall aesthetic improvement of the treated areas by treatment group, as assessed by the Investigator.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participant is willing to comply with the requirements of the study including being photographed, following post-treatment care instructions, attending all study visits and providing a signed written informed consent.
* Males or non-pregnant, non-breastfeeding females, over the age of 18.
* Intent to receive treatment for temporary augmentation in the chin region.
Exclusion Criteria:
* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins and/or local anesthetics, e.g., lidocaine or other amide-type anesthetics
* Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
* Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from the lower orbital rim.
* Any previous aesthetic procedures or implants.
* Use of concomitant medication that have the potential to prolong bleeding times such as anticoagulants or inhibitors of platelet aggregation.
* Participation in any other interventional clinical study within 30 days (about 4 and a half weeks) before baseline.
* Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period.
What they're measuring
1
Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the Global Aesthetic Improvement Scale (GAIS) at Week 8