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

Keloids Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00987545
• Other study ID #: CQAX576A2206
• Status: Terminated
• Phase: Phase 2
• Start date: June 2009
• Est. completion date: November 2010

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Keloid
• Keloids
• Recurrence

Intervention

Drug:
• QAX576
QAX576 injection
• QAX576 placebo
Placebo to QAX576 injection

Locations

Country	Name	City	State
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	TKL Research, Inc	Paramus	New Jersey
United States	Skin Search of Rochester/Dermatology Associates	Rochester	New York

Sponsors (5)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Dermatology Consulting Services, High Point NC, Skin Search, TKL Research, Inc., Virginia Clinical Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of keloids after shave removal.		At 13 weeks and 26 weeks with a follow up visit at 52 weeks after the first infusion
Secondary	To assess the mechanism biomarker responses post-shave removal of keloids for confirmation in Part I and application in Part II		Two weeks post-shave removal of keloids

External Links

•   Results for CQAX576A2206 from the Novartis Clinical Trials website