Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid Fillers Clinical Trial
Official title:
A Post-Market, Randomized, Placebo-Controlled Study to Assess the Efficacy of Cosmeceutical Therapy in Subjects Undergoing Full Facial Rejuvenation
| NCT number | NCT02726451 |
| Other study ID # | PCA-SD-01 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2016 |
| Est. completion date | December 11, 2016 |
| Verified date | September 2020 |
| Source | DeNova Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective of this study is to determine the efficacy of Sensi Peel®, Rejuvenating
Serum, and the C&E Strength Max skin care products in subjects who undergo full facial
rejuvenation, with a botulinum neurotoxin A and/or hyaluronic acid filler, in improving the
appearance of the skin, patient satisfaction with aesthetic appearance, and the projected
first impressions.
The secondary objective of this study is to examine patient satisfaction with the continuous
use of Sensi Peel®, Rejuvenating Serum, and the C&E Strength Max products.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | December 11, 2016 |
| Est. primary completion date | November 7, 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 21 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Subject is a female between the ages of 21 and 60; - Subject requires a full facial rejuvenation with a HA soft tissue filler and/or botulinum neurotoxin, per judgment of the PI or designee; - 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 in the 12-month or neurotoxin treatments in the 4-month period prior to enrollment; - Previous treatment with any resurfacing facial aesthetic procedure (e.g. deep chemical peeling and laser treatments) within the 12-month period prior to enrollment; - Previous treatment with photo rejuvenation therapy within the 6-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 | C-GAIS by the PI or Designee | Global aesthetic improvement in subjects is assessed by the PI/designee using the Global Aesthetic Improvement Scale (C-GAIS). Clinical-Global Aesthetic Improvement Scale (C-GAIS): 3 (Very Much Improved) 2 (Much Improved) 1 (Improved) 0 (No change) -1 (Worse) Scores closer to 3 show a more favorable outcome Scores closer to -1 show a less favorable outcome |
Approximately 3 months from the baseline visit | |
| Primary | SQA by the PI or Designee | The quality of subjects' skin is assessed by PI/designee using the Skin Quality Assessment (SQA) Skin Quality Assessment (SQA): Tone (dyschromia) 0 - severe unevenness 1- moderate to severe unevenness 2 - moderate unevenness 3 - mild unevenness 4 - even Elasticity (Firmness) 0 - Very poor elasticity - poor elasticity - fair elasticity - good elasticity - firm Texture (Smoothness) 0 - severe - moderate to severe - moderate - mild - none Radiance 0 - severe dullness - moderate to severe dullness - moderate dullness - mild dullness - radiant All scores with a higher number indicate favorable results All scores with a lower number indicate less favorable results |
Approximately 3 months from the baseline visit | |
| Secondary | Face-Q by Subjects | Subjects self-evaluation of their quality of skin, age-appraisal, and social and psychological assessments are performed using the Face-Q questionnaire. FACE-Q (Satisfaction with Skin): scored between 1-4 for 12 questions. Total score closer to 48 indicates a more favorable outcome FACE-Q (Satisfaction with Facial Appearance Overall): scored between 1-4 for 10 questions. Total score closer to 40 indicates a more favorable outcome FACE-Q (Aging Appearance Appraisal): scored between 1-4 for 7 questions. Total score closer to 28 indicates a more favorable outcome FACE-Q (Age Appraisal-VAS): scored between -15 to +15. Total score closer to -15 indicates a more favorable outcome FACE-Q (Psychological Well-Being): scored between 1-4 for 10 questions. Total score closer to 40 indicates a more favorable outcome FACE-Q (Social Function):scored between 1-4 for 8 questions. Total score closer to 32 indicates a more favorable outcome |
Final assessment is approximately 3 months from the baseline visit | |
| Secondary | SSES by Subjects | Changes in self-esteem is assessed using the State Self-Esteem Scale (SSES): performance, social, and appearance State Self-Esteem Scale (SSES): scored between 1-5 for 20 questions. Scores closer to 100 indicate a more favorable outcome |
Final assessment is approximately 3 months from the baseline visit | |
| Secondary | FIQ by Blinded Evaluators | The projected first impressions are assessed by blinded evaluators using the First Impression Questionnaire (FIQ). First Impression Questionnaire (FIQ): scored between 1-10 for 8 questions. Scores closer to 10 for each question indicate a more favorable outcome |
At the conclusion of study assessments (approximately 3 months from the baseline visit) |