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Artefill for the Treatment of HIV-associated Facial Lipoatrophy

NCT02009462 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-07-15

No results posted yet for this study

Summary

Artefill is an injectable facial filler device that is currently approved by the FDA for the correction of nasolabial folds. This study seeks to examine the use of Artefill in the treatment of HIV associated facial lipoatrophy. Facial lipoatrophy (facial fat loss) related to HIV is a stigmatizing condition characterized by loss of facial fat, most notably in the cheeks and temples.

Conditions

  • HIV-facial Lipoatrophy

Interventions

DRUG

Artefill dermal filler

Four treatment visits will be scheduled at baseline and at weeks 4, 12, and 24. Each treatment session will utilize no more than 8 mL of Artefill and no more than 30 syringes of Artefill.

Sponsors & Collaborators

  • Suneva Medical, Inc.

    collaborator INDUSTRY

  • Gerald Pierone, Jr. M.D.

    lead OTHER

Principal Investigators

  • Gerald Pierone, Jr., M.D · AIDS Research and Treatment Center of the Treasure Coast

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2019-11-30
Completion
2019-11-30

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 NCT02009462 on ClinicalTrials.gov