Status:
TERMINATED
Efficacy 2 Part Study of Identification of Keloid Biomarkers and Effect of QAX576 on Keloid Recurrence
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
TKL Research, Inc.
Dermatology Consulting Services, High Point NC
Conditions:
Keloids
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00987545
Start Date
June 1 2009
End Date
November 1 2010
Last Update
December 19 2020
Active Locations (4)
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1
TKL Research, Inc
Paramus, New Jersey, United States, 07652
2
Skin Search of Rochester/Dermatology Associates
Rochester, New York, United States, 14623
3
Dermatology Consulting Services
High Point, North Carolina, United States, 27262
4
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507