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Efficacy 2 Part Study of Identification of Keloid Biomarkers and Effect of QAX576 on Keloid Recurrence

NCT00987545 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2020-12-19

No results posted yet for this study

Summary

This is a 2-part study. In the first part (Part I, 8 subjects), biopsies will be obtained from the resection site after keloid shaving and two weeks following resection to assess and select biomarkers to determine the biologic effects that occur in shaved keloids. No drug will be administered.

In Part II (32 patients) will be randomized to receive QAX576 or placebo. An initial drug infusion will be followed by shave removal of keloids 6 - 8 days later followed by two additional drug infusions 4 weeks apart. Two weeks following resection, punch biopsies will be performed to assess biomarker responses. Patients will be followed-up for 52 weeks after first drug administration to assess keloid recurrence (clinically and by 3D imaging), and by physician's and patient's cosmetic assessments, and safety.

Conditions

  • Keloids

Interventions

DRUG

QAX576

QAX576 injection

DRUG

QAX576 placebo

Placebo to QAX576 injection

Sponsors & Collaborators

  • TKL Research, Inc.

    collaborator INDUSTRY

  • Dermatology Consulting Services, High Point NC

    collaborator OTHER

  • Skin Search

    collaborator UNKNOWN

  • Virginia Clinical Research, Inc.

    collaborator OTHER

  • Novartis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00987545 on ClinicalTrials.gov