Clinical Trials Logo
  1. Home
  2. Fibrosis
  3. NCT01978301

Study to Evaluate Fractional Collagen Synthesis Within Keloid Scars and Identify Biomarkers of Keloid Scars

Fibrosis Clinical Trial

Official title:
A Randomised Open Label Placebo Controlled Study to Evaluate Fractional Collagen Synthesis in Keloids and Identify Biomarkers of Keloid Biology for Potential Application in Future Clinical Trials

Clinical Trial Summary

This is a 3-arm randomised clinical enabling study, with no investigational product. Keloid patients who are scheduled for surgical excision of one or more keloid scars (up to nine) will be recruited to the study. The aim is to investigate how collagen synthesis within keloid scars is affected by the current approved steroid treatment for keloids, triamcinolone acetonide (TAC). The primary endpoint will be fractional collagen synthesis in keloids which have received intra-lesional injections of TAC, placebo or no treatment prior to their removal. Fractional collagen synthesis will be determined using an established isotope/mass spectrometric technique which measures levels of deuterium incorporation into collagen following administration of heavy water to the subject. In addition; keloid tissue samples will be evaluated post surgery to identify further biomarkers of extracellular matrix synthesis and degradation for application in future clinical studies. Subjects will complete a screening visit and will then be randomised to receive three intra-lesional injections of TAC or placebo, or no treatment, at an interval of 2-3 weeks. Subjects will be randomised to different treatment sequences depending on the number of keloids they have scheduled for surgery, in such a way that subjects with multiple keloids will receive different arms of study treatment in their different keloids. Planned surgery for removal of their keloid(s) will be performed at week 6-8. All subjects will receive daily heavy water (Deuterium oxide) administration (twice daily or thrice daily as directed), with the first dose being taken at the Week 2 clinic visit and the final dose being taken on the day prior to surgery. A follow-up visit will be conducted at 1-4 weeks post-surgery.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01978301
Study type Interventional
Source GlaxoSmithKline
Contact
Status Terminated
Phase Phase 1
Start date April 15, 2014
Completion date February 5, 2015
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05570058 - Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis Phase 2
Completed NCT03979417 - Identification of Biomarkers Related to Liver Fibrosis as New Therapeutic Targets
Completed NCT02408744 - Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease Phase 1/Phase 2
Active, not recruiting NCT00148837 - Efficacy of Prazosin Versus Placebo Associated With Peg-Interferon Alpha 2b and Ribavirin in Chronic Hepatitis C With Genotype 1 or 4 and Severe Fibrosis Phase 2
Recruiting NCT05661123 - Effect of Modified Complete Decongestive Therapy on Lower Limbs Fibrosis Post Cellulitis N/A
Recruiting NCT04795570 - Urethral Stricture After Transurethral Resection of the Prostate/Bladder: a Prospective Study of Risk Factors
Active, not recruiting NCT05075785 - Covid-19 Respiratory Sequelae French Cohort
Recruiting NCT03308916 - Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers N/A
Recruiting NCT05459259 - Physiotherapy for Arthrofibrosis Following Knee Replacement.
Enrolling by invitation NCT01483248 - Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis Phase 1/Phase 2
Completed NCT00001729 - Combination Drug Therapy for Patients With Hepatitis C Phase 3
Completed NCT02049307 - Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial Phase 2
Active, not recruiting NCT05685823 - The Impact of Conventional Hemodialysis and Renal Transplantation on the Global Longitudinal Strain of the Left Ventricle
Completed NCT00744939 - Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist Phase 4
Completed NCT00252642 - Peginterferon Alpha-2a Maintenance Therapy for Portal Hypertension in Patients With Hepatitis C N/A
Recruiting NCT04934202 - Cohort Follow-up of Survivors of Hospitalization for COVID-19 During the 2nd Wave of the Epidemic in France
Completed NCT02774161 - B-mode Ultrasound Imaging in Detecting Early Liver Cancer N/A
Completed NCT02604862 - Imaging FIB ONE in the Human Lung Using Endomicroscopy Early Phase 1
Active, not recruiting NCT01246388 - Non-Invasive Evaluation of Fibrosis and Steatosis in Chronic Hepatopathy N/A
Completed NCT00347009 - Adefovir Dipivoxil For The Treatment Of Patients With Chronic Hepatitis B Related Advanced Fibrosis Or Cirrhosis Phase 4