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

This study has been terminated.

First Received on September 30, 2009. Last Updated on January 12, 2011 History of Changes

Sponsor:	Novartis Pharmaceuticals
Collaborators:	TKL Research, Paramus NJ Dermatology Consulting Services, High Point NC Skin Search, Rochester NY Virginia Clinical Research, Norfolk VA
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00987545

Purpose

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	Intervention	Phase
Keloids	Drug: QAX576 Drug: QAX576 placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	3
Study Start Date:	June 2009
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: QAX576 placebo
Experimental: QAX576	Drug: QAX576

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987545

Locations

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, Paramus NJ

Dermatology Consulting Services, High Point NC

Skin Search, Rochester NY

Virginia Clinical Research, Norfolk VA

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00987545 History of Changes
Other Study ID Numbers:	CQAX576A2206
Study First Received:	September 30, 2009
Last Updated:	January 12, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Keloids
recurrence

Additional relevant MeSH terms:

Keloid
Recurrence
Collagen Diseases
Connective Tissue Diseases

Cicatrix
Fibrosis
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on February 09, 2012