Subjects Requesting and Requiring Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid FillersNCT02551562
A Study to Assess the Efficacy of Skin Rejuvenation Therapy in Combination With Neurotoxin and Full Facial Filler Treatments
A study testing NuDerm® System in people with Subjects Requesting and Requiring Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid Fillers, run by DeNova Research at 1 site in United States.
Trial summary
20 female subjects, between the ages of 25 and 60, who request a full facial rejuvenation treatment, meet all the inclusion and none of the exclusion criteria, and have signed a written informed consent, will be enrolled. Subjects will be divided randomly into two treatment groups: 1. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Subjects Requesting and Requiring Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid Fillers
- What is being tested?
- NuDerm® System
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2015to 9 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject requires a full facial rejuvenation with a HA soft tissue filler and/or botulinum neurotoxin, per judgment of the PI;
- 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 or neurotoxin treatments in the 12-month period prior to enrollment;
- Previous treatment with any facial aesthetic procedure (e.g. chemical peeling, photo rejuvenation, and laser treatments) within the 12-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;
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- 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.
About this study
Official title: A Post-market, Randomized Study to Assess the Efficacy of Skin Rejuvenation Therapy in Combination With Neurotoxin and Full Facial Filler Treatments
20 female subjects, between the ages of 25 and 60, who request a full facial rejuvenation treatment, meet all the inclusion and none of the exclusion criteria, and have signed a written informed consent, will be enrolled. Subjects will be divided randomly into two treatment groups:
- Group A: subjects will use a basic skin care regime following a full facial rejuvenation with hyaluronic acid soft-tissue filler and botulinum neurotoxin.
- Group B: subjects will use the Nu-Derm® system following a full facial rejuvenation with hyaluronic acid soft-tissue filler and botulinum neurotoxin.
Read more
The study consists of 5 visits: Baseline/Screening Assessments (Visit 1), Treatment (Visit 2), Two-Week Evaluation (Visit 3), Six-Week Evaluation (Visit 4), and Twelve-Week Evaluation (Visit 5).
Changes in the subjects' quality of skin will be determined by the PI's assessment of skin tone (dyschromia), elasticity (firmness), texture (smoothness), radiance, and wrinkling as well as the global aesthetic improvement at 6 and 12 weeks following neurotoxin and hyaluronic acid treatments. The PI will be blind to the group assignment of the subjects.
Subjects' satisfaction with treatments and their quality of skin will be determined through a self-evaluation at 6 and 12 weeks following neurotoxin and hyaluronic acid treatments. The impact of treatments on subjects' state self-esteem will also be assessed at 6 and 12 weeks following the treatments.
- Being tested
- NuDerm® System, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuDerm® SystemOther
The Nu-Derm® System (Valeant Pharmaceuticals North America, LLP) is a skin care system that helps correct and reduce visible signs of aging such as age spots, rough skin, erythema, sallowness, and hyperpigmentation.
PlaceboOther
Basic skin care regimen
| Study group | Role | What they receive |
|---|---|---|
| Group A: Basic Skin Care | Placebo comparator | Subjects will use a basic skin care regime following a full facial rejuvenation with hyaluronic acid soft-tissue filler and botulinum neurotoxin. Receives: Other: Placebo |
| Group B: NuDerm® System | Experimental | Subjects will use the Nu-Derm® system following a full facial rejuvenation with hyaluronic acid soft-tissue filler and botulinum neurotoxin. Receives: Other: NuDerm® System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall aesthetic improvements
The primary objective of this study is to examine the effect of skin rejuvenation therapy in combination with full facial rejuvenation, via neurotoxin or HA soft-tissue filler, on the overall aesthetic improvements.
Measured: 90 Days
Secondary outcomes (1)
State Self-Esteem
The secondary objective of this study is to assess the impact of skin quality and aesthetic improvements on short-term self-esteem.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study start6 Oct 2015
- Primary completion9 Sep 2016
- Study completion9 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects Requesting and Requiring 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeNova Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven H Dayan, MD, Principal investigator, DeNova Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551562
- Sponsor's protocol ID
- NuD-SD-01
- Status last verified
- Feb 2019
- First submitted
- 14 Sep 2015
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market, Randomized Study to Assess the Efficacy of Skin Rejuvenation Therapy in Combination With Neurotoxin and Full Facial Filler Treatments
- ClinicalTrials.gov ID
- NCT02551562
- Acronym / sponsor ID
- NuD-SD-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- DeNova ResearchUniversity, hospital or other
- Study start
- 6 Oct 2015 (actual)
- Primary completion
- 9 Sep 2016 (actual)
- Study completion
- 9 Sep 2016 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
20 female subjects, between the ages of 25 and 60, who request a full facial rejuvenation treatment, meet all the inclusion and none of the exclusion criteria, and have signed a written informed consent, will be enrolled. Subjects will be divided randomly into two treatment groups:
- Group A: subjects will use a basic skin care regime following a full facial rejuvenation with hyaluronic acid soft-tissue filler and botulinum neurotoxin.
- Group B: subjects will use the Nu-Derm® system following a full facial rejuvenation with hyaluronic acid soft-tissue filler and botulinum neurotoxin.
The study consists of 5 visits: Baseline/Screening Assessments (Visit 1), Treatment (Visit 2), Two-Week Evaluation (Visit 3), Six-Week Evaluation (Visit 4), and Twelve-Week Evaluation (Visit 5).
Changes in the subjects' quality of skin will be determined by the PI's assessment of skin tone (dyschromia), elasticity (firmness), texture (smoothness), radiance, and wrinkling as well as the global aesthetic improvement at 6 and 12 weeks following neurotoxin and hyaluronic acid treatments. The PI will be blind to the group assignment of the subjects.
Subjects' satisfaction with treatments and their quality of skin will be determined through a self-evaluation at 6 and 12 weeks following neurotoxin and hyaluronic acid treatments. The impact of treatments on subjects' state self-esteem will also be assessed at 6 and 12 weeks following the treatments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Basic Skin Care | Placebo comparator | Other: PlaceboSubjects will use a basic skin care regime following a full facial rejuvenation with hyaluronic acid soft-tissue filler and botulinum neurotoxin. |
| Group B: NuDerm® System | Experimental | Other: NuDerm® SystemSubjects will use the Nu-Derm® system following a full facial rejuvenation with hyaluronic acid soft-tissue filler and botulinum neurotoxin. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject requires a full facial rejuvenation with a HA soft tissue filler and/or botulinum neurotoxin, per judgment of the PI;
- 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 (24 listed)
- Subjects who have received any facial filler or neurotoxin treatments in the 12-month period prior to enrollment;
- Previous treatment with any facial aesthetic procedure (e.g. chemical peeling, photo rejuvenation, and laser treatments) within the 12-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;
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 |
|---|---|---|
| NuDerm® SystemThe Nu-Derm® System (Valeant Pharmaceuticals North America, LLP) is a skin care system that helps correct and reduce visible signs of aging such as age spots, rough skin, erythema, sallowness, and hyperpigmentation. | Other | Group B: NuDerm® System |
| PlaceboBasic skin care regimen | Other | Group A: Basic Skin Care |
Primary outcome
Overall aesthetic improvements
Time frame: 90 Days
The primary objective of this study is to examine the effect of skin rejuvenation therapy in combination with full facial rejuvenation, via neurotoxin or HA soft-tissue filler, on the overall aesthetic improvements.
1 secondary outcome
State Self-Esteem
Time frame: 90 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
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 NuDerm® System in people with Subjects Requesting and Requiring 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 4 inclusion and 24 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 8 Feb 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall aesthetic improvements (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2019.