Title
Efficacy 2 Part Study of Identification of Keloid Biomarkers and Effect of QAX576 on Keloid Recurrence
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
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.
QAX576 injection
Placebo to QAX576 injection
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.
