Efficacy 2 Part Study of Identification of Keloid Biomarkers and Effect of QAX576 on Keloid Recurrence
Status:
Terminated
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Novartis Pharmaceuticals
Collaborators:
Dermatology Consulting Services, High Point NC Skin Search TKL Research, Inc. Virginia Clinical Research, Inc.