Safety Study of Cosmetic Tissue Augmentation in People of Color

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

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)

Study Overview

• Status: Completed
• Conditions: Wrinkles
• Intervention / Treatment: Device: Elevess

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90036
      • Vitiligo and Pigmentation Inst of Southern California
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Skin Care Research, Inc.
    • Coral Gables, Florida, United States, 33146
      • Dermatology Research Institute, LLC
    • Miami, Florida, United States, 33144
      • International Dermatology Research
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • William Coleman, MD
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • New York
    • New York, New York, United States, 10025
      • St Luke's Roosevelt
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tenneesee Clinical Research Center
  • Texas
    • Austin, Texas, United States, 78759
      • Derm Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keloid Formation at Site of Injection	Percentage of Subjects with keloid formation at the site of injection	2 Weeks
Keloid Formation at Site of Injection	Percentage of Subjects with keloid formation at the site of injection	6 Weeks
Keloid Formation at Site of Injection	Percentage of Subjects with keloid formation at the site of injection	12 Weeks
Keloid Formation at Site of Injection	Percentage of subjects with keloid formation at the site of injection at End of Study	24 Weeks
Pigmentation Changes at Site of Injection	Percentage of Subjects with pigmentation changes at site of injection	2 Weeks
Pigmentation Changes at Site of Injection	Percentage of Subjects with pigmentation changes at site of injection	6 Weeks
Pigmentation Changes at Site of Injection	Percentage of Subjects with pigmentation changes at site of injection	12 Weeks
Pigmentation Changes at Site of Injection	Percentage of subjects with pigmentation changes at site of injection at End of Study	24 Weeks

Collaborators and Investigators

• Sponsor: Anika Therapeutics, Inc.
• Investigators: Principal Investigator: Alicia Barba, MD, International Dermatology Research, Inc.; Principal Investigator: Eduardo Tschen, MD, Academic Dermatology Associates; Principal Investigator: Frederic Brandt, MD, Dermatology Research Institute, LLC; Principal Investigator: William P Coleman, MD, Private Practice; 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.

Publications and helpful links

General Publications

• Kokelj F, Burnett JW. Treatment of a pigmented lesion induced by a Pelagia noctiluca sting. Cutis. 1990 Jul;46(1):62-4.
• Linder SA, Mele JA 3rd, Harries T. Chronic hyperpigmentation from a heated mustard compress burn: a case report. J Burn Care Rehabil. 1996 Jul-Aug;17(4):351-2. doi: 10.1097/00004630-199607000-00012.
• Royston SL, Wright PA, Widdowson DC, Wareham WJ, Strike PW. Adverse effects reported in epilatory ruby laser treatment. Lasers Med Sci. 2008 Jan;23(1):35-9. doi: 10.1007/s10103-007-0451-0. Epub 2007 Mar 13.
• Tomita Y, Maeda K, Tagami H. Mechanisms for hyperpigmentation in postinflammatory pigmentation, urticaria pigmentosa and sunburn. Dermatologica. 1989;179 Suppl 1:49-53. doi: 10.1159/000248449.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: June 3, 2010
• First Submitted That Met QC Criteria: June 17, 2010
• First Posted (Estimate): June 22, 2010

Study Record Updates

• Last Update Posted (Actual): October 17, 2017
• Last Update Submitted That Met QC Criteria: September 15, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Cosmetic; Nasolabial Folds; Injectable Dermal Filler; Hyaluronic Acid with Lidocaine
• Other Study ID Numbers: CTA0701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO