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

• Sponsor: DeNova Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT02726451
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 9.4
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid Fillers	Other: Basic Skin Care; Other: Active Skin Care	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Other
• Official Title: A Post-Market, Randomized, Placebo-Controlled Study to Assess the Efficacy of Cosmeceutical Therapy in Subjects Undergoing Full Facial Rejuvenation
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Nov 7, 2016
• Actual Study Completion Date: Dec 11, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. C-GAIS by the PI or Designee [Approximately 3 months from the baseline visit]

   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

2. SQA by the PI or Designee [Approximately 3 months from the baseline visit]

   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

Secondary Outcome Measures

1. Face-Q by Subjects [Final assessment is approximately 3 months from the baseline visit]

   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

2. SSES by Subjects [Final assessment is approximately 3 months from the baseline visit]

   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

3. FIQ by Blinded Evaluators [At the conclusion of study assessments (approximately 3 months from the baseline visit)]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DeNova Research	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• DeNova Research

Investigators

• Principal Investigator: Steven H Dayan, MD, DeNova Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DeNova Research
• ClinicalTrials.gov Identifier: NCT02726451
• Other Study ID Numbers: PCA-SD-01
• First Posted: Apr 1, 2016
• Last Update Posted: Oct 14, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Facies

Study Results

Participant Flow

Arm/Group Title	Basic Skin Care	Active Skin Care
Arm/Group Description	Subjects use a basic skin care regimen. Basic Skin Care: Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)	Subjects use the Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products in additional to a basic skin care regiment. 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®)
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Basic Skin Care	Active Skin Care	Total
Arm/Group Description	Subjects use a basic skin care regimen. Basic Skin Care: Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)	Subjects use the Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products in additional to a basic skin care regiment. 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®)	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	8 80%	7 70%	15 75%
>=65 years	2 20%	3 30%	5 25%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	54.3	54.3	54.3
Sex: Female, Male (Count of Participants)
Female	10 100%	10 100%	20 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	C-GAIS by the PI or Designee
Description	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
Time Frame	Approximately 3 months from the baseline visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Basic Skin Care	Active Skin Care
Arm/Group Description	Subjects use a basic skin care regimen. Basic Skin Care: Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)	Subjects use the Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products in additional to a basic skin care regiment. 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®)
Measure Participants	10	10
Visit 7	1.22 (0.441)	2.13 (0.835)
Visit 8/9	1.75 (0.886)	2.75 (0.787)

2. Primary Outcome

Title	SQA by the PI or Designee
Description	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
Time Frame	Approximately 3 months from the baseline visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Basic Skin Care	Active Skin Care
Arm/Group Description	Subjects use a basic skin care regimen. Basic Skin Care: Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)	Subjects use the Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products in additional to a basic skin care regiment. 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®)
Measure Participants	10	10
Tone - Visit 1	1.44 (0.527)	1.20 (0.422)
Tone - Visit 7	1.78 (0.667)	2.75 (0.707)
Tone - Visit 8/9	2.88 (0.641)	3.14 (0.690)
Elasticity - Visit 1	1.33 (0.5)	1.30 (0.483)
Elasticity - Visit 7	2.33 (0.5)	3.25 (0.886)
Elasticity - Visit 8/9	2.75 (0.707)	3.57 (0.535)
Texture - Visit 1	1.11 (0.601)	1.10 (0.316)
Texture - Visit 7	2.33 (0.5)	3.25 (0.886)
Texture - Visit 8/9	2.88 (0.835)	3.71 (0.488)
Radiance - Visit 1	0.88 (0.354)	1.0 (.0)
Radiance - Visit 7	2.25 (0.707)	3.25 (0.886)
Radiance - Visit 8/9	3.00 (0.926)	3.71 (0.488)

3. Secondary Outcome

Title	Face-Q by Subjects
Description	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
Time Frame	Final assessment is approximately 3 months from the baseline visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Basic Skin Care	Active Skin Care
Arm/Group Description	Subjects use a basic skin care regimen. Basic Skin Care: Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)	Subjects use the Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products in additional to a basic skin care regiment. 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®)
Measure Participants	10	10
Satisfaction with Skin - V5	3.21 (0.88)	3.54 (0.778)
Satisfaction with Skin - V7	3.27 (0.667)	3.29 (0.787)
Satisfaction with Skin - V8/9	3.6 (0.641)	3.18 (0.690)
Satisfaction with Facial Appearance Overall - V5	3.14 (0.5)	3.13 (0.483)
Satisfaction with Facial Appearance Overall - V7	3.08 (0.5)	3.06 (0.886)
Satisfaction with Facial Appearance Overall - V8/9	3.46 (0.707)	3.1 (0.535)
Aging Appearance Appraisal - V5	2.22 (0.601)	1.79 (0.316)
Aging Appearance Appraisal - V7	2.08 (0.5)	1.88 (0.886)
Aging Appearance Appraisal - V8/9	1.45 (0.835)	1.61 (0.488)
Age Appraisal-VAS - V5	-2 (0.354)	-3 (0.5)
Age Appraisal-VAS - V7	-2.22 (0.707)	-3.13 (0.886)
Age Appraisal-VAS - V8/9	-5.38 (0.926)	-3.57 (0.488)
Psychological Well-Being - V5	3.5 (0.568)	3.54 (0.526)
Psychological Well-Being - V7	3.52 (0.552)	3.66 (0.59)
Psychological Well-Being - V8/9	3.81 (0.699)	3.8 (0.658)
Social Function - V5	3.51 (0.553)	3.53 (0.633)
Social Function - V7	3.56 (0.878)	3.58 (0.925)
Social Function - V8/9	3.67 (0.787)	3.57 (0.477)

4. Secondary Outcome

Title	SSES by Subjects
Description	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
Time Frame	Final assessment is approximately 3 months from the baseline visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Basic Skin Care	Active Skin Care
Arm/Group Description	Subjects use a basic skin care regimen. Basic Skin Care: Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)	Subjects use the Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products in additional to a basic skin care regiment. 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®)
Measure Participants	10	10
Baseline	80.5 (0.527)	78.5 (0.422)
Visit 7	79 (0.886)	80 (0.707)
Visit 8/9	84 (0.641)	85 (0.690)

5. Secondary Outcome

Title	FIQ by Blinded Evaluators
Description	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
Time Frame	At the conclusion of study assessments (approximately 3 months from the baseline visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Basic Skin Care	Active Skin Care
Arm/Group Description	Subjects use a basic skin care regimen. Basic Skin Care: Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)	Subjects use the Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products in additional to a basic skin care regiment. 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®)
Measure Participants	10	10
Social skills - Before	4.9525 (0.79094)	5.0600 (0.83857)
Social skills - After	5.9136 (0.64010)	6.3333 (1.67975)
Academic Performance - Before	5.3400 (0.83351)	5.3900 (0.78095)
Academic Performance - After	6.1550 (0.48823)	6.2800 (1.63815)
Dating success - Before	4.6700 (1.21824)	5.0367 (0.99995)
Dating success - After	5.5470 (0.85017)	6.1433 (1.85263)
Occupational success - Before	5.3350 (0.93159)	5.5233 (0.77835)
Occupational success - After	6.0723 (0.57428)	6.3967 (1.58576)
Attractiveness - Before	4.7225 (1.27725)	4.9467 (1.07574)
Attractiveness - After	5.7758 (1.03805)	6.0867 (1.95090)
Financial Success - Before	5.3025 (0.92139)	5.3567 (0.81363)
Financial Success - After	6.0309 (0.61463)	6.2467 (1.58249)
Relationship success - Before	5.0850 (0.96094)	5.2167 (0.76078)
Relationship success - After	5.9597 (0.69371)	6.3233 (1.70127)
Athletic success - Before	4.6475 (1.31627)	4.6767 (1.03115)
Athletic success - After	5.4897 (0.96880)	5.7467 (1.67741)

Adverse Events

Time Frame	6 months
Arm/Group Title	Basic Skin Care		Active Skin Care
Arm/Group Description	Subjects use a basic skin care regimen. Basic Skin Care: Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)		Subjects use the Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products in additional to a basic skin care regiment. 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®)
All Cause Mortality
	Basic Skin Care		Active Skin Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Basic Skin Care		Active Skin Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Basic Skin Care		Active Skin Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.