Clinical trial NCT02726451: A Study to Examine the Effects of Cosmeceutical Therapy in Subjects Undergoing Full Facial Rejuvenation
Official title: A Post-Market, Randomized, Placebo-Controlled Study to Assess the Efficacy of Cosmeceutical Therapy in Subjects Undergoing Full Facial Rejuvenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid Fillers
Lead sponsor: DeNova Research
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 20
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: C-GAIS by the PI or Designee
timeFrame: Approximately 3 months from the baseline visit
measure: SQA by the PI or Designee
timeFrame: Approximately 3 months from the baseline visit
Secondary outcomes:
measure: Face-Q by Subjects
timeFrame: Final assessment is approximately 3 months from the baseline visit
measure: SSES by Subjects
timeFrame: Final assessment is approximately 3 months from the baseline visit
measure: FIQ by Blinded Evaluators
timeFrame: At the conclusion of study assessments (approximately 3 months from the baseline visit)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
Study officials:
affiliation: DeNova Research
name: Steven H Dayan, MD
role: PRINCIPAL_INVESTIGATOR
References: