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

NCT ID: NCT02726451

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-12-11

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.

Conditions

Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid Fillers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Basic Skin Care

Subjects use a basic skin care regimen.

Group Type: PLACEBO_COMPARATOR

Basic Skin Care

Intervention Type: OTHER

Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)

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.

Group Type: ACTIVE_COMPARATOR

Active Skin Care

Intervention Type: OTHER

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®)

Interventions

Basic Skin Care

Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)

Intervention Type: 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®)

Intervention Type: OTHER

Other Intervention Names

Group A; Group B

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

DeNova Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven H Dayan, MD

Role: PRINCIPAL_INVESTIGATOR

DeNova Research

Locations

DeNova Research

Chicago, Illinois, United States

Countries

United States

Other Identifiers

PCA-SD-01

Identifier Type: -

Identifier Source: org_study_id