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Safety Study of Cosmetic Tissue Augmentation in People of Color

NCT01147172 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-10-17

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Anika Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Frederic Brandt, MD · Dermatology Research Institute, LLC

  • William P Coleman, MD · Private Practice

  • Michael Gold, MD · Tennessee Clinical Research Center

  • Alicia Barba, MD · International Dermatology Research, Inc.

  • Andrew Alexis, MD · St. Luke's-Roosevelt Hospital Center

  • Michael Jarratt, MD · Derm Research, Inc.

  • Pearl Grimes, MD · Vitiligo & Pigmentation Institute of Southern California

  • Marta Rendon, MD · Skin Care Research, Inc.

  • Eduardo Tschen, MD · Academic Dermatology Associates

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-12-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01147172 on ClinicalTrials.gov