Keloids Clinical Trial
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
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00993005 -
CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars
|
Phase 3 | |
| Terminated |
NCT01425216 -
Sorafenib for Patients With Extensive Keloids
|
Phase 2 | |
| Active, not recruiting |
NCT01113125 -
Scars After Central Venous Catheters
|
Phase 3 | |
| Completed |
NCT00142441 -
Effect of Pulse Width on Scar Treatment Using a 595-nm Pulsed Dye Laser
|
N/A | |
| Completed |
NCT00476801 -
UVA1 Light for Treatment of Scleroderma and Similar Conditions
|
N/A | |
| Completed |
NCT01078428 -
Effect of Transparent, Self-drying Silicone Gel on the Treatment of Hypertrophic Abdominal Scars
|
Phase 4 |