Efficacy 2 Part Study of Identification of Keloid Biomarkers and Effect of QAX576 on Keloid Recurrence - Full Text View

Sponsor:	Novartis Pharmaceuticals
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:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
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 ]

Estimated Enrollment:	40
Study Start Date:	June 2009
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Drug: QAX576 placebo
QAX576: Experimental	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 measure ≥ 1.5 cm and ≤ 2.5 cm at its base and have been present for ≥ 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 to 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

Contacts

Contact: Novartis Pharmaceuticals

862-778-8300

Locations

United States, Florida
University of Miami Miller School of Medicine	Withdrawn
Miami, Florida, United States, FL 33136
United States, New Jersey
TKL Research, Inc	Recruiting
Paramus, New Jersey, United States, NJ 07652
Contact: TKL Research Inc 201-587-0500

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CQAX576A2206
Study First Received:	September 30, 2009
Last Updated:	November 5, 2009
ClinicalTrials.gov Identifier:	NCT00987545 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Keloids
recurrence

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Skin Diseases
Collagen Diseases

Keloid
Connective Tissue Diseases
Recurrence
Cicatrix

ClinicalTrials.gov processed this record on February 08, 2010