Ecchymosis and Erythema Commonly Associated With Soft Tissue Filler InjectionsNCT01919359
A Study of Nutritional Supplementation in Altering Ecchymosis, Erythema and Health Outcomes Associated With Aesthetic Procedures
A study testing Multizyme Cellular Vitality Cyruta Plus SHEP in people with Ecchymosis and Erythema Commonly Associated With Soft Tissue Filler Injections, run by DeNova Research at 1 site in United States.
Trial summary
Nutritional supplementation is more effective than placebo in the reduction of redness and bruising following facial ablative laser resurfacing treatments and following soft tissue filler injections to the lips and/or malar areas. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ecchymosis and Erythema Commonly Associated With Soft Tissue Filler Injections
- What is being tested?
- Multizyme Cellular Vitality Cyruta Plus SHEP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Oct 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females aged 18 or greater.
- Subjects requesting full facial ablative laser resurfacing treatment or soft tissue filler augmentation to the lips and/or malar areas.
- Subjects willing to abstain from exclusionary procedures in the treatment area (i.e., injectable fillers, laser or chemical resurfacing, botulinum toxin type A, facial cosmetic surgery).
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
- Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following is documented on the medical history:
- postmenopausal for at least 12 months prior to study drug administration
Show all 28Show fewer
- without a uterus and/or both ovaries
- has had a bilateral tubal ligation for at least 6 months prior to study drug administration.
- absence of an other physical condition according to the PI's discretion
- Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup).
- Willingness and ability to provide written informed consent prior to performance of any study related procedure.
- Exclusionary Criteria
- Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
- Subjects with a known allergy or sensitivity to any component of the study treatment or anesthesia.
- Subjects who have had prior exposure to any permanent filler in the area(s) to be treated.
- Ablative skin resurfacing on the malar area within the previous 6 months.
- Current history of nutritional supplementation (14 day washout period)
- Retinoid, microdermabrasion, or prescription level glycolic acid treatments to the malar area within 2 weeks prior to study participation or during the study.
- Active infection in the malar area (e.g., acute acne lesions or ulcers).
- Current history of chronic drug or alcohol abuse.
- History of autoimmune disease.
- Current history of blood thinners (aspirin, ibuprofen, naprosyn, herbal supplements, Vitamin E, etc.)
- Current history of tobacco use
- Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
- Subjects who anticipate the need for surgery or overnight hospitalization during the study.
- Subjects who, in the Investigator's opinion, have a history of poor cooperation, non¬compliance with medical treatment or unreliability.
- Enrollment in any active study involving the use of investigational devices or drugs.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blinded, Randomized Placebo Controlled Study to Assess the Efficacy of Nutritional Supplementation in Altering Ecchymosis, Erythema and Health Outcomes Associated With Aesthetic Procedures
Nutritional supplementation is more effective than placebo in the reduction of redness and bruising following facial ablative laser resurfacing treatments and following soft tissue filler injections to the lips and/or malar areas.
- Being tested
- Multizyme Cellular Vitality Cyruta Plus SHEP
- Keywords
- ablative laser, soft tissue filler
- Medical subject headings
- Ecchymosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multizyme Cellular Vitality Cyruta Plus SHEPDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Facial filler w/vitamin,Placebo/Resurfacing w/vitamin, placebo | Experimental | Multizyme 150C 2 caps 2 times/day between meals Day of tx for 30 days Cyruta Plus 90T 1 cap 3 times/day 30 days before and after tx or Multizyme 150C 2caps 2 times/day between meals Day of Tx for 30 days; SHEP 2caps 2 times/day 30 days before and after Tx Cellular Vitality 90C 1cap 3 times/day 30 days before and after Tx Receives: Dietary Supplement: Multizyme Cellular Vitality Cyruta Plus SHEP |
| Soft Tissue filler sugar pill | Placebo comparator | Placebo Analog 2tabs 2 times/day between meals; Day of tx for 30 days; Placebo Analog 1tab 3 times/day 30 days before and after tx or Placebo Analog (A) 2
1cap 2 times/day between meals; Day of Tx for 30 days Placebo Analog (B) 2caps 2 times/day 30 days before and after Tx Placebo Analog (C) 1cap 3 times/day 30 days before and after Tx Receives: Dietary Supplement: Multizyme Cellular Vitality Cyruta Plus SHEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canfield Vectra Photography
The Primary objective of this study is to determine the efficacy of nutritional supplements for the reduction of ecchymosis and erythema associated with aesthetic procedures.
Reduction in ecchymosis and erythema will be determined by evaluation of red, green and blue color values of 3D patient photography using the Canfield Vectra.
Measured: baseline, within 30 minutes post injection/laser, Day 1, Day 3, Day 7 and Day 30.
Secondary outcomes (1)
Heatherton & Polivy State Self-Esteem (HPSS) Scale, (SkinReplica) at Day 30 as compared to baseline (ablative laser group only, Global Aesthetic Improvement Scale (GAIS,
to evaluate the effects of nutritional supplementation with the following assessments: Improvement in self-esteem at all follow-up visits compared to baseline as assessed using the Heatherton \& Polivy State Self-Esteem (HPSS) Scale Improvement in fine lines and wrinkles in the crow's feet area as assessed using silicon profilometry (SkinReplica) at Day 30 as compared to baseline (ablative laser group only) Improvement in aesthetic appearance at all follow-up visits as assessed by the subject's assessments of photography from the Canfield Vectra 3D Imaging Severity of ecchymosis assessed using a 5-point categorical scale within 30 minutes post injection/laser and all subsequent follow up visits Severity of erythema as assessed using a 4-point scale within 30 minutes post injection/laser and all subsequent follow up visits Subject satisfaction with healing assessed at Day 7 and 30 Severity and duration of adverse events measured by 30-day patient diary
Measured: 30 min post injections- 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ecchymosis and Erythema Commonly Associated With Soft Tissue Filler InjectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeNova Research
- Sponsor type
- University, hospital or other
- Collaborators
- Standard Process Inc.
- Responsible party
- Principal investigator, Steven H. Dayan, DeNova Research
- Investigators
- Steven H Dayan, MD FACS, Principal investigator, DeNova Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919359
- Sponsor's protocol ID
- PS-SUP-12
- Status last verified
- May 2018
- First submitted
- 7 Aug 2013
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Randomized Placebo Controlled Study to Assess the Efficacy of Nutritional Supplementation in Altering Ecchymosis, Erythema and Health Outcomes Associated With Aesthetic Procedures
- ClinicalTrials.gov ID
- NCT01919359
- Acronym / sponsor ID
- PS-SUP-12
- Keywords
- ablative laser, soft tissue filler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- DeNova ResearchUniversity, hospital or other
- Collaborators
- Standard Process Inc.
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Aug 2013 (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.
Nutritional supplementation is more effective than placebo in the reduction of redness and bruising following facial ablative laser resurfacing treatments and following soft tissue filler injections to the lips and/or malar areas.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facial filler w/vitamin,Placebo/Resurfacing w/vitamin, placebo | Experimental | Dietary Supplement: Multizyme Cellular Vitality Cyruta Plus SHEPMultizyme 150C 2 caps 2 times/day between meals Day of tx for 30 days Cyruta Plus 90T 1 cap 3 times/day 30 days before and after tx or Multizyme 150C 2caps 2 times/day between meals Day of Tx for 30 days; SHEP 2caps 2 times/day 30 days before and after Tx Cellular Vitality 90C 1cap 3 times/day 30 days before and after Tx |
| Soft Tissue filler sugar pill | Placebo comparator | Dietary Supplement: Multizyme Cellular Vitality Cyruta Plus SHEPPlacebo Analog 2tabs 2 times/day between meals; Day of tx for 30 days; Placebo Analog 1tab 3 times/day 30 days before and after tx or Placebo Analog (A) 2 1cap 2 times/day between meals; Day of Tx for 30 days Placebo Analog (B) 2caps 2 times/day 30 days before and after Tx Placebo Analog (C) 1cap 3 times/day 30 days before and after Tx |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Males and females aged 18 or greater.
- Subjects requesting full facial ablative laser resurfacing treatment or soft tissue filler augmentation to the lips and/or malar areas.
- Subjects willing to abstain from exclusionary procedures in the treatment area (i.e., injectable fillers, laser or chemical resurfacing, botulinum toxin type A, facial cosmetic surgery).
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
- Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following is documented on the medical history:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Multizyme Cellular Vitality Cyruta Plus SHEP | Dietary supplement | Facial filler w/vitamin,Placebo/Resurfacing w/vitamin, placebo, Soft Tissue filler sugar pill |
Primary outcome
Canfield Vectra Photography
Time frame: baseline, within 30 minutes post injection/laser, Day 1, Day 3, Day 7 and Day 30.
The Primary objective of this study is to determine the efficacy of nutritional supplements for the reduction of ecchymosis and erythema associated with aesthetic procedures. Reduction in ecchymosis and erythema will be determined by evaluation of red, green and blue color values of 3D patient photography using the Canfield Vectra.
1 secondary outcome
Heatherton & Polivy State Self-Esteem (HPSS) Scale, (SkinReplica) at Day 30 as compared to baseline (ablative laser group only, Global Aesthetic Improvement Scale (GAIS,
Time frame: 30 min post injections- 30 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 1 Jun 2018.
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 FACS 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 Multizyme Cellular Vitality Cyruta Plus SHEP in people with Ecchymosis and Erythema Commonly Associated With Soft Tissue Filler Injections, 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 28 inclusion and 0 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 1 Jun 2018. 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?
Canfield Vectra Photography (time frame: baseline, within 30 minutes post injection/laser, Day 1, Day 3, Day 7 and Day 30.). 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 1 Jun 2018.