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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device | Experimental | Treatment with EVOLENCE® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVOLENCE® | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months post injection |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Wrinkle Severity Score | Baseline, 1, 3 and 6 months post injection | |
| Investigator's Satisfaction of the Overall Treatment | 1, 3 and 6 months post injection | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Shoshani, MD | Colbar/OrthoDermatologics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Vitiligo and Pigmentation Institute of Southern California | Los Angeles | California | 90036 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Device | Treatment with EVOLENCE® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Subject's Satisfaction of the Overall Treatment |
| 1, 3 and 6 months post injection |
| Desert Dermatology Medical Associates |
| Rancho Mirage |
| California |
| 92270 |
| United States |
| Center for Dermatology and Dermatologic Surgery | Washington D.C. | District of Columbia | 20037 | United States |
| Atlanta Dermatology Vein & Research Center | Alpharetta | Georgia | 30022 | United States |
| Denova Research | Chicago | Illinois | 60611 | United States |
| DuPage Medical Group Clinical Research | Naperville | Illinois | 60563 | United States |
| Callender Center for Clinical Research | Mitchellville | Maryland | 20721 | United States |
| The Boyd Gillard Institute of Aesthetic & Dermatology Surgery | Ypsilanti | Michigan | 48197 | United States |
| Image Dermatology | Montclair | New Jersey | 07042 | United States |
| Susan Taylor | Philadelphia | Pennsylvania | 19107 | United States |
| Tennessee Clinical Research | Nashville | Tennessee | 37215 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Device | Treatment with EVOLENCE® |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Fitzpatrick Skin Tone | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | Participants | 6 months post injection |
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| Secondary | Reduction in Wrinkle Severity Score | Sponsor made business decision to discontinue marketing of product in US and program was terminated before full analysis of results. No analysis was performed on Secondary Outcome Measures. Sincere efforts were made to obtain secondary outcome measure data; there is no longer access to these data and therefore no data can be reported. | Posted | Baseline, 1, 3 and 6 months post injection |
|
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| Secondary | Investigator's Satisfaction of the Overall Treatment | Sponsor made business decision to discontinue marketing of product in US and program was terminated before full analysis of results. No analysis was performed on Secondary Outcome Measures. Sincere efforts were made to obtain secondary outcome measure data; there is no longer access to these data and therefore no data can be reported. | Posted | 1, 3 and 6 months post injection |
|
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| Secondary | Subject's Satisfaction of the Overall Treatment | Sponsor made business decision to discontinue marketing of product in US and program was terminated before full analysis of results. No analysis was performed on Secondary Outcome Measures. Sincere efforts were made to obtain secondary outcome measure data; there is no longer access to these data and therefore no data can be reported. | Posted | 1, 3 and 6 months post injection |
|
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6 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Device | Treatment with EVOLENCE® | 3 | 158 | 154 | 154 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Enlarging Multifibroid Uterus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Bladder Failure | Renal and urinary disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Administration Site Conditions | General disorders | Systematic Assessment |
| ||
| Oral or Upper Respiratory Infections | Infections and infestations | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Sponsor discontinued US marketing of product; program terminated. No analysis performed on Secondary Measures. Sincere efforts were made to obtain secondary measure data; there is no longer access to these data and therefore no data can be reported.
No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written consent. The Institution will provide Sponsor with at least sixty (60) days for review of a manuscript, and if requested in writing, the Institution and Principal Investigators will withhold such publication for up to an additional sixty (60) days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joyce Hauze, RPS Sr. Specialist, Clinical Research Operations | Johnson & Johnson Consumer and Personal Products Worldwide | 928-277-0715 | jhauze@its.jnj.com |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| VI (Dark Brown/Black) |
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| Title | Measurements |
|---|---|
|