Safety Study of Cosmetic Tissue Augmentation in People of Color

NCT01147172 | Completed Results

• 1 other identifier: CTA0701
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

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)

Conditions

Wrinkles

Keywords

Nasolabial Folds; Cosmetic; Injectable Dermal Filler; Hyaluronic Acid with Lidocaine

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

Elevess

EXPERIMENTAL

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

Interventions

Elevess DEVICE

Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles

Elevess

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Anika Therapeutics, Inc.: lead

Study Sites (9)

Vitiligo and Pigmentation Inst of Southern California

Los Angeles, California, 90036, United States

Location

Skin Care Research, Inc.

Boca Raton, Florida, 33486, United States

Location

Dermatology Research Institute, LLC

Coral Gables, Florida, 33146, United States

Location

International Dermatology Research

Miami, Florida, 33144, United States

Location

William Coleman, MD

Metairie, Louisiana, 70006, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

St Luke's Roosevelt

New York, New York, 10025, United States

Location

Tenneesee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Derm Research, Inc.

Austin, Texas, 78759, United States

Location

Related Publications (4)

• Kokelj F, Burnett JW. Treatment of a pigmented lesion induced by a Pelagia noctiluca sting. Cutis. 1990 Jul;46(1):62-4.

  PMID: 1974491 BACKGROUND

• 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.

  PMID: 8844357 BACKGROUND

• 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.

  PMID: 17431730 BACKGROUND

• 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.

  PMID: 2550287 BACKGROUND

Results Point of Contact

• Title: Adrian Orr, Director Clinical Affairs
• Organization: Anika Therapeutics

aorr@anikatherapeutics.com

781.457.9000

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 22, 2010
• Study Start: March 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: August 1, 2010
• Last Updated: October 17, 2017
• Results First Posted: April 20, 2015

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)