Trial Outcomes & Findings for A Study to Examine the Effects of Cosmeceutical Therapy in Subjects Undergoing Full Facial Rejuvenation (NCT NCT02726451)

Last Updated: 2020-10-14

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Approximately 3 months from the baseline visit

Results posted on

2020-10-14

Participant Flow

Participant milestones

Participant milestones
Measure	Basic Skin Care 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®)	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. 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®)
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Basic Skin Care n=10 Participants 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®)	Active Skin Care n=10 Participants 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 n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	54.3 years n=5 Participants	54.3 years n=7 Participants	54.3 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 3 months from the baseline visit

Outcome measures

Outcome measures
Measure	Basic Skin Care n=10 Participants 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®)	Active Skin Care n=10 Participants 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®)
C-GAIS by the PI or Designee Visit 7	1.22 units on a scale Standard Deviation 0.441	2.13 units on a scale Standard Deviation 0.835
C-GAIS by the PI or Designee Visit 8/9	1.75 units on a scale Standard Deviation 0.886	2.75 units on a scale Standard Deviation 0.787

PRIMARY outcome

Timeframe: 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 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

Outcome measures

Outcome measures
Measure	Basic Skin Care n=10 Participants 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®)	Active Skin Care n=10 Participants 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®)
SQA by the PI or Designee Tone - Visit 1	1.44 units on a scale Standard Deviation 0.527	1.20 units on a scale Standard Deviation 0.422
SQA by the PI or Designee Tone - Visit 7	1.78 units on a scale Standard Deviation 0.667	2.75 units on a scale Standard Deviation 0.707
SQA by the PI or Designee Tone - Visit 8/9	2.88 units on a scale Standard Deviation 0.641	3.14 units on a scale Standard Deviation 0.690
SQA by the PI or Designee Elasticity - Visit 1	1.33 units on a scale Standard Deviation 0.5	1.30 units on a scale Standard Deviation 0.483
SQA by the PI or Designee Elasticity - Visit 7	2.33 units on a scale Standard Deviation 0.5	3.25 units on a scale Standard Deviation 0.886
SQA by the PI or Designee Elasticity - Visit 8/9	2.75 units on a scale Standard Deviation 0.707	3.57 units on a scale Standard Deviation 0.535
SQA by the PI or Designee Texture - Visit 1	1.11 units on a scale Standard Deviation 0.601	1.10 units on a scale Standard Deviation 0.316
SQA by the PI or Designee Texture - Visit 7	2.33 units on a scale Standard Deviation 0.5	3.25 units on a scale Standard Deviation 0.886
SQA by the PI or Designee Texture - Visit 8/9	2.88 units on a scale Standard Deviation 0.835	3.71 units on a scale Standard Deviation 0.488
SQA by the PI or Designee Radiance - Visit 1	0.88 units on a scale Standard Deviation 0.354	1.0 units on a scale Standard Deviation .0
SQA by the PI or Designee Radiance - Visit 7	2.25 units on a scale Standard Deviation 0.707	3.25 units on a scale Standard Deviation 0.886
SQA by the PI or Designee Radiance - Visit 8/9	3.00 units on a scale Standard Deviation 0.926	3.71 units on a scale Standard Deviation 0.488

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Basic Skin Care n=10 Participants 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®)	Active Skin Care n=10 Participants 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®)
Face-Q by Subjects Satisfaction with Skin - V5	3.21 units on a scale Standard Deviation 0.88	3.54 units on a scale Standard Deviation 0.778
Face-Q by Subjects Satisfaction with Skin - V7	3.27 units on a scale Standard Deviation 0.667	3.29 units on a scale Standard Deviation 0.787
Face-Q by Subjects Satisfaction with Skin - V8/9	3.6 units on a scale Standard Deviation 0.641	3.18 units on a scale Standard Deviation 0.690
Face-Q by Subjects Satisfaction with Facial Appearance Overall - V5	3.14 units on a scale Standard Deviation 0.5	3.13 units on a scale Standard Deviation 0.483
Face-Q by Subjects Satisfaction with Facial Appearance Overall - V7	3.08 units on a scale Standard Deviation 0.5	3.06 units on a scale Standard Deviation 0.886
Face-Q by Subjects Satisfaction with Facial Appearance Overall - V8/9	3.46 units on a scale Standard Deviation 0.707	3.1 units on a scale Standard Deviation 0.535
Face-Q by Subjects Aging Appearance Appraisal - V5	2.22 units on a scale Standard Deviation 0.601	1.79 units on a scale Standard Deviation 0.316
Face-Q by Subjects Aging Appearance Appraisal - V7	2.08 units on a scale Standard Deviation 0.5	1.88 units on a scale Standard Deviation 0.886
Face-Q by Subjects Aging Appearance Appraisal - V8/9	1.45 units on a scale Standard Deviation 0.835	1.61 units on a scale Standard Deviation 0.488
Face-Q by Subjects Age Appraisal-VAS - V5	-2 units on a scale Standard Deviation 0.354	-3 units on a scale Standard Deviation 0.5
Face-Q by Subjects Age Appraisal-VAS - V7	-2.22 units on a scale Standard Deviation 0.707	-3.13 units on a scale Standard Deviation 0.886
Face-Q by Subjects Age Appraisal-VAS - V8/9	-5.38 units on a scale Standard Deviation 0.926	-3.57 units on a scale Standard Deviation 0.488
Face-Q by Subjects Psychological Well-Being - V5	3.5 units on a scale Standard Deviation 0.568	3.54 units on a scale Standard Deviation 0.526
Face-Q by Subjects Psychological Well-Being - V7	3.52 units on a scale Standard Deviation 0.552	3.66 units on a scale Standard Deviation 0.59
Face-Q by Subjects Psychological Well-Being - V8/9	3.81 units on a scale Standard Deviation 0.699	3.8 units on a scale Standard Deviation 0.658
Face-Q by Subjects Social Function - V5	3.51 units on a scale Standard Deviation 0.553	3.53 units on a scale Standard Deviation 0.633
Face-Q by Subjects Social Function - V7	3.56 units on a scale Standard Deviation 0.878	3.58 units on a scale Standard Deviation 0.925
Face-Q by Subjects Social Function - V8/9	3.67 units on a scale Standard Deviation 0.787	3.57 units on a scale Standard Deviation 0.477

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Basic Skin Care n=10 Participants 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®)	Active Skin Care n=10 Participants 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®)
SSES by Subjects Baseline	80.5 units on a scale Standard Deviation 0.527	78.5 units on a scale Standard Deviation 0.422
SSES by Subjects Visit 7	79 units on a scale Standard Deviation 0.886	80 units on a scale Standard Deviation 0.707
SSES by Subjects Visit 8/9	84 units on a scale Standard Deviation 0.641	85 units on a scale Standard Deviation 0.690

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Basic Skin Care n=10 Participants 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®)	Active Skin Care n=10 Participants 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®)
FIQ by Blinded Evaluators Social skills - Before	4.9525 units on a scale Standard Deviation 0.79094	5.0600 units on a scale Standard Deviation 0.83857
FIQ by Blinded Evaluators Social skills - After	5.9136 units on a scale Standard Deviation 0.64010	6.3333 units on a scale Standard Deviation 1.67975
FIQ by Blinded Evaluators Academic Performance - Before	5.3400 units on a scale Standard Deviation 0.83351	5.3900 units on a scale Standard Deviation 0.78095
FIQ by Blinded Evaluators Academic Performance - After	6.1550 units on a scale Standard Deviation 0.48823	6.2800 units on a scale Standard Deviation 1.63815
FIQ by Blinded Evaluators Dating success - Before	4.6700 units on a scale Standard Deviation 1.21824	5.0367 units on a scale Standard Deviation 0.99995
FIQ by Blinded Evaluators Dating success - After	5.5470 units on a scale Standard Deviation 0.85017	6.1433 units on a scale Standard Deviation 1.85263
FIQ by Blinded Evaluators Occupational success - Before	5.3350 units on a scale Standard Deviation 0.93159	5.5233 units on a scale Standard Deviation 0.77835
FIQ by Blinded Evaluators Occupational success - After	6.0723 units on a scale Standard Deviation 0.57428	6.3967 units on a scale Standard Deviation 1.58576
FIQ by Blinded Evaluators Attractiveness - Before	4.7225 units on a scale Standard Deviation 1.27725	4.9467 units on a scale Standard Deviation 1.07574
FIQ by Blinded Evaluators Attractiveness - After	5.7758 units on a scale Standard Deviation 1.03805	6.0867 units on a scale Standard Deviation 1.95090
FIQ by Blinded Evaluators Financial Success - Before	5.3025 units on a scale Standard Deviation 0.92139	5.3567 units on a scale Standard Deviation 0.81363
FIQ by Blinded Evaluators Financial Success - After	6.0309 units on a scale Standard Deviation 0.61463	6.2467 units on a scale Standard Deviation 1.58249
FIQ by Blinded Evaluators Relationship success - Before	5.0850 units on a scale Standard Deviation 0.96094	5.2167 units on a scale Standard Deviation 0.76078
FIQ by Blinded Evaluators Relationship success - After	5.9597 units on a scale Standard Deviation 0.69371	6.3233 units on a scale Standard Deviation 1.70127
FIQ by Blinded Evaluators Athletic success - Before	4.6475 units on a scale Standard Deviation 1.31627	4.6767 units on a scale Standard Deviation 1.03115
FIQ by Blinded Evaluators Athletic success - After	5.4897 units on a scale Standard Deviation 0.96880	5.7467 units on a scale Standard Deviation 1.67741

Adverse Events

Basic Skin Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Skin Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven Dayan, MD

DeNova Research

Phone: 3123352070

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place