Intrinsic Aging of SkinPhase 4JUVE_COSMO_1NCT01212809
Comparative Study of Reconstituted JUVÉDERM® Ultra vs COSMODERM® 1 for Lip and Cheek Lines, Folds or Wrinkles
A Phase 4 study testing Juvéderm Ultra and Cosmoderm 1 in people with Intrinsic Aging of Skin, run by Steven Fagien at 1 site in United States.
Trial summary
This study is being done to evaluate the differences in the performance of two well known injectable dermal fillers commonly used for the cosmetic treatment of age lines above the lips and on the cheeks when compared to each other in the same patient. The products being tested are Juvéderm® Ultra and CosmoDerm® 1. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Intrinsic Aging of Skin
- What is being tested?
- Juvéderm Ultra and Cosmoderm 1
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jun 2011
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult females or males, aged 25 to 70 years;
- Subjects must be seeking treatment with Juvéderm Ultra and CosmoDerm 1 injections for vertical lip rhytids or radial cheek lines;
- Subjects must have one or more moderate to severe vertical lip rhytids and/or moderate to severe radial cheek lines based on the physician evaluator assessment (0-3 scale);
- Women must either be of non-childbearing potential (i.e., surgically sterilized or post-menopausal) or if of childbearing potential, must not be pregnant (as documented by a negative urine pregnancy test at the baseline examination) or lactating and must be practicing a medically acceptable method of birth control;
- Subjects must be willing and able to provide written informed consent;
- Subjects must be willing and able to follow the procedures outlined in this protocol.
Who cannot join
- Female subjects who are pregnant (positive urine pregnancy test) or who have an infant they are breast-feeding or who are of childbearing potential and not practicing a reliable method of birth control;
- Previous Botox treatment to the lower two-thirds of the face within the past 6 months for subjects who will have injections into their radial cheek lines. Note: this exclusion criterion does not apply to subjects who only will have injections into lip rhytids unless the previous Botox treatment was administered within the past 6 months to the upper lip region;
- Previous semipermanent injectable filler therapy to the mid-lower face within the past year or any prior history of permanent filler therapy injection to the mid-lower face;
- Prior cosmetic procedures (i.e., facelift, etc.) or visible scars that may affect evaluation of response and/or quality of photography in the opinion of the investigator;
- Known allergy or sensitivity to any of the treatment injections or their components, including known or suspected lidocaine hypersensitivity;
- Known severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies;
Show all 12Show fewer
- Subjects with an infection at an injection site or systemic infection (in this case, postpone study entry until one week following recovery);
- Subjects requiring treatment with major anticoagulants (such as Coumadin) or antiplatelets (such as Plavix) during the study; low-dose aspirin treatment or antiinflammatory medication with potential anticoagulant or antiplatelet effect may be allowed at the investigator's discretion;
- Concurrent participation in an investigational drug or device study or participation within 30 days of study start;
- Subjects are not to undergo any additional cosmetic procedures during the study period;
- Subjects are not to change use of any facial products up to 6 months prior to enrollment and during study period;
- Subjects with a history of poor cooperation, non-compliance with medical treatment, or unreliability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open Label, Randomized, Comparative, Split-Face Study Evaluating Reconstituted JUVÉDERM® Ultra Injectable Gel Versus COSMODERM® 1 Human Based Collagen Implant for the Treatment of Vertical Lip Rhytids and Radial Cheek Lines
This study is being done to evaluate the differences in the performance of two well known injectable dermal fillers commonly used for the cosmetic treatment of age lines above the lips and on the cheeks when compared to each other in the same patient. The products being tested are Juvéderm® Ultra and CosmoDerm® 1.
Read the detailed description
This is a single center, prospective, open label, randomized, comparative, split-face study in adult females or males aged 25 to 70 years seeking treatment with reconstituted Juvéderm® Ultra and CosmoDerm® 1 human-based collagen implant for moderate to severe vertical lip rhytids and/or radial cheek lines.
- Conditions
- Intrinsic Aging of Skin
- Being tested
- Juvéderm Ultra, Cosmoderm 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juvéderm UltraDevice
Also called Juvéderm Ultra injectable gel (crosslinked hyaluronic acid)
Split-face injection of Juvéderm Ultra into vertical lip rhytids and radial cheek lines on one side of face
Cosmoderm 1Device
Also called Cosmoderm 1 human-based collagen implant
Split-face injection of Cosmoderm 1 into vertical lip rhytids and radial cheek lines on one side of face
| Study group | Role | What they receive |
|---|---|---|
| Juvéderm Ultra | Active comparator | Juvéderm Ultra injection Receives: Device: Juvéderm Ultra |
| Cosmoderm 1 | Active comparator | Cosmoderm 1 injection Receives: Device: Cosmoderm 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Assessment of Improvement by Physician Evaluator
Global Assessment of Improvement by Physician Evaluator, including Facial Photographs, Vertical Lip Rhytids and Radial Cheek Line Rating Scales
Measured: 3 days, 2 and 6 weeks, 4 and 6 months
Secondary outcomes (1)
Patient Efficacy, Pain, Adverse Event Assessments
- Facial Line Outcomes (FLO-11 version 1.0) Questionnaire - Patient
- Self-Perception of Age (SPA version 2.0) measure - Patient
- Global Assessment of Improvement - Patient
- Self-Rated Pain Assessment Scale (0-10 point rating scale)
- Treatment-emergent adverse events
Measured: 3 days, 2 and 6 weeks, 4 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrinsic Aging of SkinStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven Fagien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steven Fagien, Fagien, Steven, M.D., PA
- Investigators
- Steven Fagien, MD, Principal investigator, Steven Fagien, MD, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212809
- Sponsor's protocol ID
- JUVE_COSMO_1-10-01
- Acronym
- JUVE_COSMO_1
- Status last verified
- Sep 2011
- First submitted
- 29 Sep 2010
- Last updated
- 12 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Randomized, Comparative, Split-Face Study Evaluating Reconstituted JUVÉDERM® Ultra Injectable Gel Versus COSMODERM® 1 Human Based Collagen Implant for the Treatment of Vertical Lip Rhytids and Radial Cheek Lines
- ClinicalTrials.gov ID
- NCT01212809
- Acronym / sponsor ID
- JUVE_COSMO_1 / JUVE_COSMO_1-10-01
- Conditions
- Intrinsic Aging of Skin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Steven FagienUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Oct 2010 (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.
This study is being done to evaluate the differences in the performance of two well known injectable dermal fillers commonly used for the cosmetic treatment of age lines above the lips and on the cheeks when compared to each other in the same patient. The products being tested are Juvéderm® Ultra and CosmoDerm® 1.
Detailed description
This is a single center, prospective, open label, randomized, comparative, split-face study in adult females or males aged 25 to 70 years seeking treatment with reconstituted Juvéderm® Ultra and CosmoDerm® 1 human-based collagen implant for moderate to severe vertical lip rhytids and/or radial cheek lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Juvéderm Ultra | Active comparator | Device: Juvéderm UltraJuvéderm Ultra injection |
| Cosmoderm 1 | Active comparator | Device: Cosmoderm 1Cosmoderm 1 injection |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult females or males, aged 25 to 70 years;
- Subjects must be seeking treatment with Juvéderm Ultra and CosmoDerm 1 injections for vertical lip rhytids or radial cheek lines;
- Subjects must have one or more moderate to severe vertical lip rhytids and/or moderate to severe radial cheek lines based on the physician evaluator assessment (0-3 scale);
- Women must either be of non-childbearing potential (i.e., surgically sterilized or post-menopausal) or if of childbearing potential, must not be pregnant (as documented by a negative urine pregnancy test at the baseline examination) or lactating and must be practicing a medically acceptable method of birth control;
- Subjects must be willing and able to provide written informed consent;
Key exclusion criteria (12 listed)
- Female subjects who are pregnant (positive urine pregnancy test) or who have an infant they are breast-feeding or who are of childbearing potential and not practicing a reliable method of birth control;
- Previous Botox treatment to the lower two-thirds of the face within the past 6 months for subjects who will have injections into their radial cheek lines. Note: this exclusion criterion does not apply to subjects who only will have injections into lip rhytids unless the previous Botox treatment was administered within the past 6 months to the upper lip region;
- Previous semipermanent injectable filler therapy to the mid-lower face within the past year or any prior history of permanent filler therapy injection to the mid-lower face;
- Prior cosmetic procedures (i.e., facelift, etc.) or visible scars that may affect evaluation of response and/or quality of photography in the opinion of the investigator;
- Known allergy or sensitivity to any of the treatment injections or their components, including known or suspected lidocaine hypersensitivity;
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 |
|---|---|---|
| Juvéderm UltraAlso: Juvéderm Ultra injectable gel (crosslinked hyaluronic acid)Split-face injection of Juvéderm Ultra into vertical lip rhytids and radial cheek lines on one side of face | Device | Juvéderm Ultra |
| Cosmoderm 1Also: Cosmoderm 1 human-based collagen implantSplit-face injection of Cosmoderm 1 into vertical lip rhytids and radial cheek lines on one side of face | Device | Cosmoderm 1 |
Primary outcome
Global Assessment of Improvement by Physician Evaluator
Time frame: 3 days, 2 and 6 weeks, 4 and 6 months
Global Assessment of Improvement by Physician Evaluator, including Facial Photographs, Vertical Lip Rhytids and Radial Cheek Line Rating Scales
1 secondary outcome
Patient Efficacy, Pain, Adverse Event Assessments
Time frame: 3 days, 2 and 6 weeks, 4 and 6 months
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 12 Sep 2011.
Related trials for Intrinsic Aging of Skin
Active, not recruiting
Effects of a Multi-Targeted Oral Supplement on Skin, Hair, Sleep, Energy, Cognition, Libido and Epigenetic Biological Clock Age
Skin Ageing, Healthy Ageing
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 Fagien, MD principal investigator
Steven Fagien, MD, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Juvéderm Ultra and Cosmoderm 1 in people with Intrinsic Aging of Skin, run by Steven Fagien 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 6 inclusion and 12 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 12 Sep 2011. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Global Assessment of Improvement by Physician Evaluator (time frame: 3 days, 2 and 6 weeks, 4 and 6 months). 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 12 Sep 2011.