Subjects Requesting and Requiring Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid Fillers Clinical Trial
Official title:
A Post-market, Randomized Study to Assess the Efficacy of Skin Rejuvenation Therapy in Combination With Neurotoxin and Full Facial Filler Treatments
| Verified date | February 2019 |
| Source | DeNova Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
20 female subjects, between the ages of 25 and 60, who request a full facial rejuvenation
treatment, meet all the inclusion and none of the exclusion criteria, and have signed a
written informed consent, will be enrolled. Subjects will be divided randomly into two
treatment groups:
1. Group A: subjects will use a basic skin care regime following a full facial rejuvenation
with hyaluronic acid soft-tissue filler and botulinum neurotoxin.
2. Group B: subjects will use the Nu-Derm® system following a full facial rejuvenation with
hyaluronic acid soft-tissue filler and botulinum neurotoxin.
The study consists of 5 visits: Baseline/Screening Assessments (Visit 1), Treatment (Visit
2), Two-Week Evaluation (Visit 3), Six-Week Evaluation (Visit 4), and Twelve-Week Evaluation
(Visit 5).
Changes in the subjects' quality of skin will be determined by the PI's assessment of skin
tone (dyschromia), elasticity (firmness), texture (smoothness), radiance, and wrinkling as
well as the global aesthetic improvement at 6 and 12 weeks following neurotoxin and
hyaluronic acid treatments. The PI will be blind to the group assignment of the subjects.
Subjects' satisfaction with treatments and their quality of skin will be determined through a
self-evaluation at 6 and 12 weeks following neurotoxin and hyaluronic acid treatments. The
impact of treatments on subjects' state self-esteem will also be assessed at 6 and 12 weeks
following the treatments.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | September 9, 2016 |
| Est. primary completion date | September 9, 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 25 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Subject requires a full facial rejuvenation with a HA soft tissue filler and/or botulinum neurotoxin, per judgment of the PI; - Subject is willing and able to provide written informed consent prior to the performance of any study related procedure; - Subject is willing and able to comply with the protocol requirements; and - Subject is willing and able to provide written photo consent and adhere to the photography and video procedures such as removal of jewelry and makeup. Exclusion Criteria: - Subjects who have received any facial filler or neurotoxin treatments in the 12-month period prior to enrollment; - Previous treatment with any facial aesthetic procedure (e.g. chemical peeling, photo rejuvenation, and laser treatments) within the 12-month period prior to enrollment; - Subjects who plan to undergo facial cosmetic surgery or any aesthetic procedure (e.g. neurotoxins, dermal fillers, laser treatments, and chemical peels), which are not specified in this protocol, during the course of the study; - A known allergy or sensitivity to any component of the study ingredients; - Use of systemic steroids or anticoagulation medications; - Subjects with a history of bleeding disorders; - Subjects with severe allergies manifested by a history of anaphylaxis or presence of multiple severe allergies; - Subjects with hypersensitivity to botulinum neurotoxin; - Subject with allergies to gram positive bacterial proteins; - Sensitivity to sulfides; - Subjects with allergy to cow's milk protein; - Subjects with previous history of sensitivity to amide type local anesthetics; - Subject with surgical alterations to the facial anatomy or marked facial asymmetry; - Inflammation or infection at the injection site(s); - Subjects with a history of eyelid or eyebrow ptosis; - Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin; - Subjects with neuromuscular disorders; - Use of anticholinergic, aminoglycosides or other agents that interfere with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants; - Subjects with immunodeficiencies such as HIV, lupus, scleroderma, and systemic infections; - Pregnant, nursing, or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence); - Current history of chronic drug or alcohol abuse; - Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study product; - Subjects who, in the investigator's opinion, have a history of poor cooperation, non-compliance with medical treatment, or unreliability; and - Enrollment in any active study involving the use of investigational devices or drugs. |
| Country | Name | City | State |
|---|---|---|---|
| United States | DeNova research | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| DeNova Research |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall aesthetic improvements | The primary objective of this study is to examine the effect of skin rejuvenation therapy in combination with full facial rejuvenation, via neurotoxin or HA soft-tissue filler, on the overall aesthetic improvements. | 90 Days | |
| Secondary | State Self-Esteem | The secondary objective of this study is to assess the impact of skin quality and aesthetic improvements on short-term self-esteem. | 90 Days |