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Nasolabial Fold Filler Study for People of Color
This study is currently recruiting participants.
Verified by DeNova Research, March 2009
First Received: March 27, 2009   Last Updated: May 5, 2009   History of Changes
Sponsors and Collaborators: DeNova Research
Johnson & Johnson
Information provided by: DeNova Research
ClinicalTrials.gov Identifier: NCT00871988
  Purpose

Looking for dark skinned, ethnic individuals who have clinical evidence of moderate to deep laugh lines to enroll in a clinical trial using EVOLENCE protein based filler for the correction of facial wrinkles and folds in this area.


Condition Intervention Phase
Bilateral Wrinkles in the Nasolabial Area
Drug: EVOLENCE
Phase IV

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: An Open-Label, MultiCenter, Prospective, Postmarket Study to Assess the Safety and Effectiveness of EVOLENCE in Facial Augmentation of Subjects With Fitzpatrick Skin Color Types IV, V, and VI

Further study details as provided by DeNova Research:

Primary Outcome Measures:
  • To assess the safety EVOLENCE® in subjects with Fitzpatrick Skin Color Types IV, V, and VI seeking correction of facial wrinkles in accordance with the approved device labeling including for example correction of the nasolabial wrinkle /folds. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the device effectiveness in skin types IV, V, and VI [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: EVOLENCE
    Subjects, who fulfill all eligibility criteria, will be injected with EVOLENCE® to treat their wrinkles and folds of the nasolabial area (both sides) in accordance with the approved device labeling. Within two weeks after initial injection, a visit will be performed to evaluate if Optimal Cosmetic Result (OCR) is achieved per PI discretion. If OCR is achieved the subject will start the follow-up period of the study. If OCR has not been achieved following the initial injection, additional 'touch-up' injections may be performed. The subject will be injected as much as needed until OCR is achieved as per PI discretion.
Detailed Description:

The Primary objective of this study is to assess the safety EVOLENCE® in subjects with Fitzpatrick Skin Color Types IV, V, and VI seeking correction of facial wrinkles in accordance with the approved device labeling including for example correction of the nasolabial wrinkle /folds.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females ≥ 18 years of age with Fitzpatrick Skin Color Type IV, V and VI
  2. No history of previous facial augmentation treatments effecting areas below the zygoma.
  3. Have bilateral, fully visible aging defects in the nasolabial area, corresponding to a rating of at least 2 on the validated MFWS.
  4. Willingness and ability to comply with the protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures affecting areas below zygoma (e.g., facelift, full-mouth rehabilitation including dental implants, further augmentation therapy, laser or chemical resurfacing etc.) for the duration of the study.
  5. Women of childbearing potential must be willing and able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent,hormonal methods, IUD, surgical sterilization, abstinence) during the study.Women will not be considered of childbearing potential if one of the following is documented on the medical history:

    • postmenopausal with an absence of menses for at least 3 months.
    • bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 3 months or total hysterectomy.
    • absence of any other physical condition according to the PI's discretion (e.g., fertility treatments, donations etc.)
  6. Willingness and ability to provide written informed consent prior to performance of any study related procedure.

Exclusion Criteria:

  1. Subjects who are pregnant and/or nursing.
  2. History of allergies and/or sensitivity to porcine, bovine and human collagen, lidocaine, local anesthetics products, natural rubber latex.
  3. History of multiple severe allergies and/or anaphylactic shock.
  4. History of keloid or hypertrophic scar formation (i.e., post surgery, trauma etc).
  5. Subjects undergoing or planning to undergo desensitization injections to porcine meat products, as these injections contain porcine collagen.
  6. Clinically significant organic disease including clinically significant cardiovascular, pulmonary, neurological, hepatic or renal disease or other medical condition, serious concurrent illness or extenuating circumstance that, in the opinion of the PI, make the subject a poor candidate for participation in the study.
  7. History of autoimmune disease or collagen vascular disease, or connective tissue disease, such as rheumatoid arthritis, juvenile rheumatoid arthritis, scleroderma, or systemic lupus erythematosous, including any history of known positive ANA blood test (titer greater than or equal to 1:160).
  8. Active skin disease, inflammation or related condition such as infection, psoriasis and herpes zoster near or on the nasolabial folds area at study entry and/or within 6 months prior to study entry.
  9. Any esthetic facial surgical therapy effecting areas below the zygoma (e.g.,facelift) within 12 months prior to enrollment and during the study period.
  10. Use of botulinum-toxin A (i.e., Botox™) injections in the lower half of the face during the whole study period and use of botulinum-toxin A injections in the upper area of the face 6 weeks prior to the facial injection and for 16 weeks following the last injection.
  11. Use of Radio Frequency Skin tightening (Thermage) in the lower half of the face within 6 months prior to enrollment and during the study period.
  12. Use of non-ablative laser treatment on the lower half of the face within 6 months prior to enrollment and during the study period.
  13. Use of ablative laser treatment on the lower half of the face within 12 months prior to enrollment and during the study period.
  14. Any previous tissue augmentation (e.g., injections or other form of implantation of tissue augmenting substances from any kind, degradable, long lasting and permanent implants) on the lower half of the face (bellow the zygoma).
  15. Subjects who are currently treated with immunosuppressive drugs, chemotherapy agents or systemic steroids or have been treated within the last 3 months prior to study entry.
  16. Subjects with a history of bleeding disorders, subjects receiving chronic antiplatelet therapy or other chronic anticoagulant medication (e.g., Warfarin,Clexane, etc). Subjects in whom the use of anti-platelet or other medication with anticoagulant effect, (e.g., Vitamin E above 400IU/Day, Dietary supplements such as Flaxseed oil and Fish oil, etc.), is anticipated during the treatment period of the study should interrupt this use 7 days prior to first facial injection and at least 1 week after the last facial injection. However, subjects on low-dose aspirin or non-steroidal anti-inflammatory drugs may be included in the study, - if therapy is interrupted at least 7 days before the facial injection, and not resumed until at least one week after the last injection.
  17. Subjects using over-the-counter wrinkle products (e.g., products containing 15 % or greater of alpha-hydroxy acid or prescription wrinkle creams (e.g.,Renova) during the course of the study in the investigational area (lower half of the face).
  18. Subjects having a scar or keloid formation, pigmentation changes, facial deformities or hair (i.e., mustache) at the planned injection area.
  19. Subjects received any investigational products within 30 days prior to study enrollment. Subjects cannot receive other investigational products during 20. Subjects planning relocation making follow-up visits impossible during the course of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00871988

Contacts
Contact: Selika Borst, M.S., R.N. 312-335-2070 urakay@drdayan.com

Locations
United States, Illinois
DeNova Research Recruiting
Chicago, Illinois, United States, 60611
Contact: Selika Borst, M.S., R.N.     312-335-2070     urakay@drdayan.com    
Principal Investigator: Steven H Dayan, M.D., F.A.C.S.            
Sponsors and Collaborators
DeNova Research
Johnson & Johnson
  More Information

Additional Information:
No publications provided

Responsible Party: DeNova Research ( Steven H. Dayan, M.D./ Priciniple Investigator )
Study ID Numbers: DP101-US-04
Study First Received: March 27, 2009
Last Updated: May 5, 2009
ClinicalTrials.gov Identifier: NCT00871988     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by DeNova Research:
Filler
Cosmetic Surgery
Nasolabial Folds

Study placed in the following topic categories:
Facies

ClinicalTrials.gov processed this record on May 07, 2009