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

NCT ID: NCT00987545

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Keloids

Keywords

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Keloids recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

QAX576 placebo

Intervention Type DRUG

Placebo to QAX576 injection

QAX576

Group Type EXPERIMENTAL

QAX576

Intervention Type DRUG

QAX576 injection

Interventions

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QAX576

QAX576 injection

Intervention Type DRUG

QAX576 placebo

Placebo to QAX576 injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Patients with two or more keloids on the trunk, upper extremities or thighs. The keloids must meet specified size criteria and have been present for greater than or equal to 1 year, been stable in size and symptoms for at least 6 months.

Exclusion Criteria

* Use of other investigational drugs at the time of enrollment, or history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g. lidocaine, epinephrine, and topical antibiotics as bacitracin and neomycin).
* History of repeated recurrence of keloid after prior surgical removal (4-5 times removed).
* Keloids near the hands, joints, and anogenital areas as recurrence might cause significant problems.
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the patient in case of participation in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TKL Research, Inc.

INDUSTRY

Sponsor Role collaborator

Dermatology Consulting Services, High Point NC

OTHER

Sponsor Role collaborator

Skin Search

UNKNOWN

Sponsor Role collaborator

Virginia Clinical Research, Inc.

OTHER

Sponsor Role collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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TKL Research, Inc

Paramus, New Jersey, United States

Site Status

Skin Search of Rochester/Dermatology Associates

Rochester, New York, United States

Site Status

Dermatology Consulting Services

High Point, North Carolina, United States

Site Status

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Site Status

Countries

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United States

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5685

Results for CQAX576A2206 from the Novartis Clinical Trials website

Other Identifiers

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CQAX576A2206

Identifier Type: -

Identifier Source: org_study_id