Efficacy 2 Part Study of Identification of Keloid Biomarkers and Effect of QAX576 on Keloid Recurrence
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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 2 |
| 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 |
- 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 ]
- 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 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: QAX576 placebo
Placebo to QAX576 injection
|
| Experimental: QAX576 |
Drug: QAX576
QAX576 injection
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and 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 | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00987545 History of Changes |
| Other Study ID Numbers: | CQAX576A2206 |
| Study First Received: | September 30, 2009 |
| Last Updated: | May 2, 2012 |
| 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 May 16, 2013