Non Therapeutic Body ModificationNCT00891774
Post Market Safety Study and Effectiveness With Evolence in Subjects With Skin Color Types IV-VI
A study testing EVOLENCE® in people with Non Therapeutic Body Modification, run by Johnson & Johnson Consumer and Personal Products Worldwide at 11 sites in United States.
Trial summary
Approximately 165 subjects with Fitzpatrick Skin Color Types IV, V, and VI and a moderate to deep wrinkle between the corner of the nose and the corner of the mouth, will be treated with EVOLENCE® (an approved collagen filler) to smooth and flatten that wrinkle. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non Therapeutic Body Modification
- What is being tested?
- EVOLENCE®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 11 sitesUnited States
- Study dates
- 31 Dec 2008to 30 Nov 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years of age
- moderate to deep wrinkle in the Naso-Labial fold
- Fitzpatrick Skin Type IV, V or VI
Who cannot join
- Pregnant or nursing females
- Hx of allergies to related products
- history of keloids, active skin disease, or previous augmentation of the treatment area
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Atlanta Dermatology Vein & Research Center
Alpharetta, Georgia, 30022
Denova Research
Chicago, Illinois, 60611
The Vitiligo and Pigmentation Institute of Southern California
Los Angeles, California, 90036
Callender Center for Clinical Research
Mitchellville, Maryland, 20721
Image Dermatology
Montclair, New Jersey, 07042
DuPage Medical Group Clinical Research
Naperville, Illinois, 60563
Tennessee Clinical Research
Nashville, Tennessee, 37215
Susan Taylor
Philadelphia, Pennsylvania, 19107
Desert Dermatology Medical Associates
Rancho Mirage, California, 92270
Center for Dermatology and Dermatologic Surgery
Washington D.C., District of Columbia, 20037
The Boyd Gillard Institute of Aesthetic & Dermatology Surgery
Ypsilanti, Michigan, 48197
About this study
Official title: An Open-label, Multi-Center, Prospective, Post Market Study to Assess the Safety and Effectiveness of EVOLENCE® in Facial Augmentation of Subjects With Fitzpatrick Skin Color Types IV, V, and VI
Approximately 165 subjects with Fitzpatrick Skin Color Types IV, V, and VI and a moderate to deep wrinkle between the corner of the nose and the corner of the mouth, will be treated with EVOLENCE® (an approved collagen filler) to smooth and flatten that wrinkle. They will be observed for 6 months to establish safety of the product as it relates to scarring and changes in skin pigment, and long term effectiveness.
Read the detailed description
This is an open-label, multi-center, prospective, postmarket study to assess the safety and effectiveness of EVOLENCE® (DP101) in Subjects with Fitzpatrick Skin Color Types IV, V, and VI seeking correction of bilateral facial wrinkles and folds of the nasolabial area.
The study will enroll and treat a total of 165 subjects with Fitzpatrick Skin Color Types IV, V and VI who have clinical evidence of moderate to deep bilateral wrinkles in the nasolabial area.
- Conditions
- Non Therapeutic Body Modification
- Being tested
- EVOLENCE®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVOLENCE®Device
Also called Facial augmentation
Single injection of material into the mid-dermis of the wrinkle - Second 'touch-up' injection is permitted approximately 14-Days later if needed to achieve satisfactory results
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Treatment with EVOLENCE® Receives: Device: EVOLENCE® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint
Safety Endpoint includes three categories: 1) composite determination of success (no pigmentation change or keloid formation); 2) pigmentation changes; and 3) keloid formation
Measured: 6 months post injection
Secondary outcomes (3)
Reduction in Wrinkle Severity Score
Measured: Baseline, 1, 3 and 6 months post injection
Investigator's Satisfaction of the Overall Treatment
Measured: 1, 3 and 6 months post injection
Subject's Satisfaction of the Overall Treatment
Measured: 1, 3 and 6 months post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study start31 Dec 2008
- Primary completion30 Nov 2009
- Study completion30 Nov 2009
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 Non Therapeutic Body ModificationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Shoshani, MD, Study director, Colbar/OrthoDermatologics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891774
- Sponsor's protocol ID
- DP101 US-04
- Status last verified
- Jan 2019
- First submitted
- 30 Apr 2009
- Last updated
- 6 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-Center, Prospective, Post Market Study to Assess the Safety and Effectiveness of EVOLENCE® in Facial Augmentation of Subjects With Fitzpatrick Skin Color Types IV, V, and VI
- ClinicalTrials.gov ID
- NCT00891774
- Acronym / sponsor ID
- DP101 US-04
- Conditions
- Non Therapeutic Body Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2008 (actual)
- Primary completion
- 30 Nov 2009 (actual)
- Study completion
- 30 Nov 2009 (actual)
- First posted
- 1 May 2009 (estimated)
- Results
- Posted 13 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 165 subjects with Fitzpatrick Skin Color Types IV, V, and VI and a moderate to deep wrinkle between the corner of the nose and the corner of the mouth, will be treated with EVOLENCE® (an approved collagen filler) to smooth and flatten that wrinkle. They will be observed for 6 months to establish safety of the product as it relates to scarring and changes in skin pigment, and long term effectiveness.
Detailed description
This is an open-label, multi-center, prospective, postmarket study to assess the safety and effectiveness of EVOLENCE® (DP101) in Subjects with Fitzpatrick Skin Color Types IV, V, and VI seeking correction of bilateral facial wrinkles and folds of the nasolabial area.
The study will enroll and treat a total of 165 subjects with Fitzpatrick Skin Color Types IV, V and VI who have clinical evidence of moderate to deep bilateral wrinkles in the nasolabial area.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: EVOLENCE®Treatment with EVOLENCE® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years of age
- moderate to deep wrinkle in the Naso-Labial fold
- Fitzpatrick Skin Type IV, V or VI
Key exclusion criteria (3 listed)
- Pregnant or nursing females
- Hx of allergies to related products
- history of keloids, active skin disease, or previous augmentation of the treatment area
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 |
|---|---|---|
| EVOLENCE®Also: Facial augmentationSingle injection of material into the mid-dermis of the wrinkle - Second 'touch-up' injection is permitted approximately 14-Days later if needed to achieve satisfactory results | Device | Device |
Primary outcome
Safety Endpoint
Time frame: 6 months post injection
Safety Endpoint includes three categories: 1) composite determination of success (no pigmentation change or keloid formation); 2) pigmentation changes; and 3) keloid formation
3 secondary outcomes
Reduction in Wrinkle Severity Score
Time frame: Baseline, 1, 3 and 6 months post injection
Investigator's Satisfaction of the Overall Treatment
Time frame: 1, 3 and 6 months post injection
Subject's Satisfaction of the Overall Treatment
Time frame: 1, 3 and 6 months post injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Shoshani, MD study director
Colbar/OrthoDermatologics
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVOLENCE® in people with Non Therapeutic Body Modification, run by Johnson & Johnson Consumer and Personal Products Worldwide at 11 sites 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 3 inclusion and 3 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 6 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 11 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2011). 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?
Safety Endpoint (time frame: 6 months post injection). 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 6 Feb 2019.