DeNova Research
Chicago, Illinois, 60611, United States
NCT Number: NCT02726451
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.
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Notify Me21 year–60 year
Female
Interventional
Not applicable
Chicago, Illinois, 60611, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)
Other names: Group A
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
Time frame: 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
Time frame: 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
Texture (Smoothness) 0 - severe
Radiance 0 - severe dullness
All scores with a higher number indicate favorable results All scores with a lower number indicate less favorable results
Time frame: 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
Time frame: 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
Time frame: 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
DeNova Research
Other
A Post-Market, Randomized, Placebo-Controlled Study to Assess the Efficacy of Cosmeceutical Therapy in Subjects Undergoing Full Facial Rejuvenation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.