A Study to Assess the Efficacy of Skin Rejuvenation Therapy in Combination With Neurotoxin and Full Facial Filler Treatments
Status: | Completed |
---|---|
Conditions: | Other Indications |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 25 - 60 |
Updated: | 2/10/2019 |
Start Date: | October 6, 2015 |
End Date: | September 9, 2016 |
A Post-market, Randomized Study to Assess the Efficacy of Skin Rejuvenation Therapy in Combination With Neurotoxin and Full Facial Filler Treatments
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.
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.
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.
We found this trial at
1
site
845 North Michigan Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
312-335-2070
Principal Investigator: Steven H Dayan, MD
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