Clinical trial NCT00987545: Efficacy 2 Part Study of Identification of Keloid Biomarkers and Effect of QAX576 on Keloid Recurrence
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Keloids
Keywords: Keloids
recurrence
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: TKL Research, Inc.
name: Dermatology Consulting Services, High Point NC
name: Skin Search
name: Virginia Clinical Research, Inc.
First posted: 2009-10-01
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence of keloids after shave removal.
timeFrame: At 13 weeks and 26 weeks with a follow up visit at 52 weeks after the first infusion
Secondary outcomes:
measure: To assess the mechanism biomarker responses post-shave removal of keloids for confirmation in Part I and application in Part II
timeFrame: Two weeks post-shave removal of keloids
Other outcomes:
Locations:
city: Paramus
country: United States
facility: TKL Research, Inc
state: New Jersey
city: Rochester
country: United States
facility: Skin Search of Rochester/Dermatology Associates
state: New York
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: