Non Therapeutic Body Modification
Conditions
Brief 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. 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.
Interventions
DEVICEEVOLENCE®
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
Sponsors
Johnson & Johnson Consumer and Personal Products Worldwide
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* \>18 years of age * moderate to deep wrinkle in the Naso-Labial fold * Fitzpatrick Skin Type IV, V or VI
Exclusion criteria
* Pregnant or nursing females * Hx of allergies to related products * history of keloids, active skin disease, or previous augmentation of the treatment area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint | 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 |
Secondary
| Measure | 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 |
| Subject's Satisfaction of the Overall Treatment | 1, 3 and 6 months post injection |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device Treatment with EVOLENCE® | 172 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Illness (Self/Mother) | 3 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Device |
|---|---|
| Age, Continuous | 51.4 years STANDARD_DEVIATION 10.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 154 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Skin Tone IV (Light Brown) | 54 Participants |
| Fitzpatrick Skin Tone V (Brown) | 66 Participants |
| Fitzpatrick Skin Tone VI (Dark Brown/Black) | 52 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 135 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment North America United States | 172 Participants |
| Sex: Female, Male Female | 150 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 154 / 154 |
| serious Total, serious adverse events | 3 / 158 |
Outcome results
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
Time frame: 6 months post injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device | Safety Endpoint | Success | 155 Participants |
| Device | Safety Endpoint | Keloid Formation | 0 Participants |
| Device | Safety Endpoint | Pigmentation Change | 3 Participants |
Secondary
Investigator's Satisfaction of the Overall Treatment
Time frame: 1, 3 and 6 months post injection
Population: 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.
Secondary
Reduction in Wrinkle Severity Score
Time frame: Baseline, 1, 3 and 6 months post injection
Population: 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.
Secondary
Subject's Satisfaction of the Overall Treatment
Time frame: 1, 3 and 6 months post injection
Population: 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.