Clinical trial NCT00891774: Post Market Safety Study and Effectiveness With Evolence in Subjects With Skin Color Types IV-VI
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Therapeutic Body Modification
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2009-05-01
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety Endpoint
timeFrame: 6 months post injection
Secondary outcomes:
measure: Reduction in Wrinkle Severity Score
timeFrame: Baseline, 1, 3 and 6 months post injection
measure: Investigator's Satisfaction of the Overall Treatment
timeFrame: 1, 3 and 6 months post injection
measure: Subject's Satisfaction of the Overall Treatment
timeFrame: 1, 3 and 6 months post injection
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Vitiligo and Pigmentation Institute of Southern California
state: California
city: Rancho Mirage
country: United States
facility: Desert Dermatology Medical Associates
state: California
city: Washington
country: United States
facility: Center for Dermatology and Dermatologic Surgery
state: District of Columbia
city: Alpharetta
country: United States
facility: Atlanta Dermatology Vein & Research Center
state: Georgia
city: Chicago
country: United States
facility: Denova Research
state: Illinois
city: Naperville
country: United States
facility: DuPage Medical Group Clinical Research
state: Illinois
city: Mitchellville
country: United States
facility: Callender Center for Clinical Research
state: Maryland
city: Ypsilanti
country: United States
facility: The Boyd Gillard Institute of Aesthetic & Dermatology Surgery
state: Michigan
city: Montclair
country: United States
facility: Image Dermatology
state: New Jersey
city: Philadelphia
country: United States
facility: Susan Taylor
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Clinical Research
state: Tennessee
Study officials:
affiliation: Colbar/OrthoDermatologics
name: David Shoshani, MD
role: STUDY_DIRECTOR
References: