A Study to Examine the Effects of Cosmeceutical Therapy in Subjects Undergoing Full Facial Rejuvenation

A Post-Market, Randomized, Placebo-Controlled Study to Assess the Efficacy of Cosmeceutical Therapy in Subjects Undergoing Full Facial Rejuvenation

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.

Study Overview

• Status: Completed
• Conditions: Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid Fillers
• Intervention / Treatment: Other: Basic Skin Care; Other: Active Skin Care

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Basic Skin Care; Subjects use a basic skin care regimen.	Other: Basic Skin Care; Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®); Other Names: Group A
Active Comparator: Active Skin Care; Subjects use the Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products in additional to a basic skin care regiment.	Other: Active Skin Care; Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products (PCA SKIN®) in addition to the Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®); Other Names: Group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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)

Collaborators and Investigators

• Sponsor: DeNova Research

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): November 7, 2016
• Study Completion (Actual): December 11, 2016

Study Registration Dates

• First Submitted: March 29, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: PCA-SD-01