Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid FillersNCT02726451

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

A study testing Basic Skin Care and Active Skin Care in people with Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid Fillers, run by DeNova Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 21 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid Fillers
What is being tested?: Basic Skin Care and Active Skin Care
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Mar 2016to 11 Dec 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 60 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

DeNova Research
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: A Post-Market, Randomized, Placebo-Controlled Study to Assess the Efficacy of Cosmeceutical Therapy in Subjects Undergoing Full Facial Rejuvenation

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
Being tested: Basic Skin Care, Active Skin Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Basic Skin CareOther
Also called Group A
Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)
Active Skin CareOther
Also called Group B
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®)

Study groups in NCT02726451
Study group	Role	What they receive
Basic Skin Care	Placebo comparator	Subjects use a basic skin care regimen. Receives: 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. Receives: Other: Active Skin Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: Approximately 3 months from the baseline visit

Secondary outcomes (3)

Face-Q by Subjects
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
Measured: Final assessment is approximately 3 months from the baseline visit
SSES by Subjects
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
Measured: Final assessment is approximately 3 months from the baseline visit
FIQ by Blinded Evaluators
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
Measured: At the conclusion of study assessments (approximately 3 months from the baseline visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 201611 Dec 2016

First posted1 Apr 2016 (estimated)
Study startMar 2016
Primary completion7 Nov 2016
Study completion11 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid FillersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02726451
Sponsor's protocol ID: PCA-SD-01
Status last verified: Sep 2020
First submitted: 29 Mar 2016
Last updated: 14 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post-Market, Randomized, Placebo-Controlled Study to Assess the Efficacy of Cosmeceutical Therapy in Subjects Undergoing Full Facial Rejuvenation
ClinicalTrials.gov ID: NCT02726451
Acronym / sponsor ID: PCA-SD-01
Conditions: Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid Fillers
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: DeNova ResearchUniversity, hospital or other
Study start: Mar 2016
Primary completion: 7 Nov 2016 (actual)
Study completion: 11 Dec 2016 (actual)
First posted: 1 Apr 2016 (estimated)
Results: Posted 14 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Basic Skin Care	Placebo comparator	Other: Basic Skin CareSubjects use a basic skin care regimen.
Active Skin Care	Active comparator	Other: Active Skin CareSubjects use the Sensi Peel®, Rejuvenating Serum, and C\&E Strength Max skin care products in additional to a basic skin care regiment.

Who may qualify

Ages: 21 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (25 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Basic Skin CareAlso: Group AFacial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)	Other	Basic Skin Care
Active Skin CareAlso: Group BSensi 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	Active Skin Care

Primary outcome

C-GAIS by the PI or Designee
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
SQA by the PI or Designee
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 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

3 secondary outcomes

Face-Q by Subjects
Time frame: Final assessment is approximately 3 months from the baseline visit
SSES by Subjects
Time frame: Final assessment is approximately 3 months from the baseline visit
FIQ by Blinded Evaluators
Time frame: At the conclusion of study assessments (approximately 3 months from the baseline visit)

Results and safety

Results posted to the registry on 14 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Basic Skin Care	10	10
Active Skin Care	10	10

Primary outcome: C-GAIS by the PI or Designee

Time frame: Approximately 3 months from the baseline visit. Mean (Standard Deviation). Unit: units on a scale

Measure	Basic Skin Care n = 10	Active Skin Care n = 10
Visit 7	1.22 (0.441)	2.13 (0.835)
Visit 8/9	1.75 (0.886)	2.75 (0.787)

Primary outcome: SQA by the PI or Designee

Time frame: Approximately 3 months from the baseline visit. Mean (Standard Deviation). Unit: units on a scale

Measure	Basic Skin Care n = 10	Active Skin Care n = 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)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Basic Skin Care	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Active Skin Care	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven H Dayan, MD principal investigator

DeNova Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Basic Skin Care and Active Skin Care in people with Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid Fillers, run by DeNova Research at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

C-GAIS by the PI or Designee (time frame: Approximately 3 months from the baseline visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02726451.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.