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Safety Study of Cosmetic Tissue Augmentation in People of Color

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01147172
Recruitment Status : Completed
First Posted : June 22, 2010
Results First Posted : April 20, 2015
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
Anika Therapeutics, Inc.

Brief Summary:

Elevess is intended for all skin types. However, further study of all soft tissue fillers is needed in people of color because of the increasing use of cosmetic dermal filler products.

This study is designed to evaluate the safety of an injectable hyaluronic acid based dermal filler Elevess (Anika Therapeutics, Inc., Bedford, MA). Safety will be evaluated by incidence and severity of keloid formation and pigmentation changes, and other potential adverse events in people with Fitzpatrick skin types IV, V and VI who have elected to undergo nasolabial fold (NLF) treatment with Elevess.

1. Fitzpatrick Classification of Skin Type as: IV - Burns minimally, always tans well (moderate/light brown skin; Mediterranean, Asian, Hispanic. V - Rarely burns, tans profusely (dark brown/brown skin: Middle eastern, Latin, light skinned Black, Indian) VI - Never burns, (deeply pigmented dark brown to black skin;Black)


Condition or disease Intervention/treatment Phase
Wrinkles Device: Elevess Not Applicable

Detailed Description:

This study is designed to be an open-label, longitudinal, uncontrolled study in a minimum of 100 subjects with Fitzpatrick scale skin type of IV, V or VI at 10 or more U.S. centers who have elected to undergo NLF treatment with intradermal (deep dermal) injection of Elevess. Subjects will be followed for a minimum of 24 weeks with visit assessments at 2, 6, 12 and 24 weeks after the last injection.

Safety: Primary Safety Endpoint assessments will be: 1) keloid formation at the site of injection at 2, 6, 12 and 24 weeks, 2) pigmentation changes at the site of injection compared to adjacent skin at 2, 6, 12 and 24 weeks, and 3) overall adverse events. A subject diary will also be collected.

Effectiveness: No formal effectiveness evaluation will be performed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Post Approval, Multicenter, Open-Label, Longitudinal, Uncontrolled Safety Study of Cosmetic Tissue Augmentation Product (ELEVESS™) in the Treatment of Nasolabial Folds in People of Color
Study Start Date : March 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics

Arm Intervention/treatment
Experimental: Elevess
Gel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite
Device: Elevess
Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles




Primary Outcome Measures :
  1. Keloid Formation at Site of Injection [ Time Frame: 2 Weeks ]
    Percentage of Subjects with keloid formation at the site of injection

  2. Keloid Formation at Site of Injection [ Time Frame: 6 Weeks ]
    Percentage of Subjects with keloid formation at the site of injection

  3. Keloid Formation at Site of Injection [ Time Frame: 12 Weeks ]
    Percentage of Subjects with keloid formation at the site of injection

  4. Keloid Formation at Site of Injection [ Time Frame: 24 Weeks ]
    Percentage of subjects with keloid formation at the site of injection at End of Study

  5. Pigmentation Changes at Site of Injection [ Time Frame: 2 Weeks ]
    Percentage of Subjects with pigmentation changes at site of injection

  6. Pigmentation Changes at Site of Injection [ Time Frame: 6 Weeks ]
    Percentage of Subjects with pigmentation changes at site of injection

  7. Pigmentation Changes at Site of Injection [ Time Frame: 12 Weeks ]
    Percentage of Subjects with pigmentation changes at site of injection

  8. Pigmentation Changes at Site of Injection [ Time Frame: 24 Weeks ]
    Percentage of subjects with pigmentation changes at site of injection at End of Study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Fitzpatrick skin type of IV, V or VI.
  • Bilateral nasolabial folds which, in the investigator's judgment, can be corrected with Elevess.
  • Age greater or equal to 18 years.

Exclusion Criteria:

  • Fitzpatrick skin type of I, II or III.
  • Subject has severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.
  • Subject has allergies to the components of Elevess: hyaluronic acid, lidocaine, sodium metabisulfite or gram positive bacterial proteins.
  • Subject has a history of severe keloids and/or hypertrophic scars.
  • Subject has ever received any soft tissue augmentation in any area of the face and subject is unwilling to forgo all other soft tissue augmentation for the duration of the study.
  • Subject has received any aesthetic or dermatologic treatments or procedures in any area of the face in the previous 6 months and subject is unwilling to forgo such treatments or procedures for the duration of the study.
  • Subject has active facial acne lesions, severe acne scarring or pigmentation disorders at the injection site that might affect clinical assessment of the nasolabial folds.
  • Subject has ever received an injection or implant of silicone in any area of the face.
  • Subject has received immunosuppressive therapy, chemotherapy, or systemic corticosteroids within the last 3 months.
  • Subject has a history of a connective tissue disease.
  • Subject is positive for HIV/AIDS or hepatitis C.
  • Subject is involved in any other research study involving an investigational product (drug, device or biologic) or a new application of an approved product, within 30 days of screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01147172


Locations
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United States, California
Vitiligo and Pigmentation Inst of Southern California
Los Angeles, California, United States, 90036
United States, Florida
Skin Care Research, Inc.
Boca Raton, Florida, United States, 33486
Dermatology Research Institute, LLC
Coral Gables, Florida, United States, 33146
International Dermatology Research
Miami, Florida, United States, 33144
United States, Louisiana
William Coleman, MD
Metairie, Louisiana, United States, 70006
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, New York
St Luke's Roosevelt
New York, New York, United States, 10025
United States, Tennessee
Tenneesee Clinical Research Center
Nashville, Tennessee, United States, 37215
United States, Texas
Derm Research, Inc.
Austin, Texas, United States, 78759
Sponsors and Collaborators
Anika Therapeutics, Inc.
Investigators
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Principal Investigator: Frederic Brandt, MD Dermatology Research Institute, LLC
Principal Investigator: William P Coleman, MD Private Practice
Principal Investigator: Michael Gold, MD Tennessee Clinical Research Center
Principal Investigator: Alicia Barba, MD International Dermatology Research, Inc.
Principal Investigator: Andrew Alexis, MD St. Luke's-Roosevelt Hospital Center
Principal Investigator: Michael Jarratt, MD Derm Research, Inc.
Principal Investigator: Pearl Grimes, MD Vitiligo & Pigmentation Institute of Southern California
Principal Investigator: Marta Rendon, MD Skin Care Research, Inc.
Principal Investigator: Eduardo Tschen, MD Academic Dermatology Associates

Publications:
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Responsible Party: Anika Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01147172    
Other Study ID Numbers: CTA0701
First Posted: June 22, 2010    Key Record Dates
Results First Posted: April 20, 2015
Last Update Posted: October 17, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Anika Therapeutics, Inc.:
Nasolabial Folds
Cosmetic
Injectable Dermal Filler
Hyaluronic Acid with Lidocaine