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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00987545
Recruitment Status : Terminated (Negative pharmacodynamics due to lack of Interleukin-13 signature in biomarker data from Part I of the study.)
First Posted : October 1, 2009
Last Update Posted : May 4, 2012
TKL Research, Inc.
Dermatology Consulting Services, High Point NC
Skin Search
Virginia Clinical Research, Inc.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Keloids Drug: QAX576 Drug: QAX576 placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Post-shave Keloid Recurrence Study in Two Parts: A Biomarker Assessment Followed by a Randomized, Double-blind, Placebo Controlled Evaluation of Safety, Tolerability, and Efficacy of QAX576
Study Start Date : June 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: QAX576 placebo
Placebo to QAX576 injection

Experimental: QAX576 Drug: QAX576
QAX576 injection

Primary Outcome Measures :
  1. Recurrence of keloids after shave removal. [ Time Frame: At 13 weeks and 26 weeks with a follow up visit at 52 weeks after the first infusion ]

Secondary Outcome Measures :
  1. To assess the mechanism biomarker responses post-shave removal of keloids for confirmation in Part I and application in Part II [ Time Frame: Two weeks post-shave removal of keloids ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Other protocol-defined inclusion/exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00987545

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United States, New Jersey
TKL Research, Inc
Paramus, New Jersey, United States, 07652
United States, New York
Skin Search of Rochester/Dermatology Associates
Rochester, New York, United States, 14623
United States, North Carolina
Dermatology Consulting Services
High Point, North Carolina, United States, 27262
United States, Virginia
Virginia Clinical Research, Inc.
Norfold, Virginia, United States, 23507
Sponsors and Collaborators
Novartis Pharmaceuticals
TKL Research, Inc.
Dermatology Consulting Services, High Point NC
Skin Search
Virginia Clinical Research, Inc.
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00987545    
Other Study ID Numbers: CQAX576A2206
First Posted: October 1, 2009    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes
Collagen Diseases
Connective Tissue Diseases