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

NCT02726451 | Completed Results

• 1 other identifier: PCA-SD-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 1. \- poor elasticity 2. \- fair elasticity 3. \- good elasticity 4. \- firm Texture (Smoothness) 0 - severe 1. \- moderate to severe 2. \- moderate 3. \- mild 4. \- none Radiance 0 - severe dullness 1. \- moderate to severe dullness 2. \- moderate dullness 3. \- mild dullness 4. \- 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 Outcomes (3)

• Face-Q by Subjects

  Final assessment is approximately 3 months from the baseline visit

• SSES by Subjects

  Final assessment is approximately 3 months from the baseline visit

• FIQ by Blinded Evaluators

  At the conclusion of study assessments (approximately 3 months from the baseline visit)

Study Arms (2)

Basic Skin Care

PLACEBO COMPARATOR

Subjects use a basic skin care regimen.

Other: Basic Skin Care

Active Skin Care

ACTIVE COMPARATOR

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

Interventions

Basic Skin Care OTHER

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

Also known as: Group A

Basic Skin Care

Active Skin Care 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®)

Also known as: Group B

Active Skin Care

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• DeNova Research: lead

Study Sites (1)

DeNova Research

Chicago, Illinois, 60611, United States

Location

Results Point of Contact

• Title: Steven Dayan, MD
• Organization: DeNova Research

sdayan@drdayan.com

3123352070

Study Officials

• Steven H Dayan, MD

  DeNova Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 1, 2016
• Study Start: March 1, 2016
• Primary Completion: November 7, 2016
• Study Completion: December 11, 2016
• Last Updated: October 14, 2020
• Results First Posted: October 14, 2020

Record last verified: 2020-09

Locations

US (1)