Track topics on Twitter Track topics that are important to you
The purpose of this study is to determine the safety and local toleration and histological effects of various dose levels of avotermin (Juvista) injected intradermally in healthy male volunteers.
The study was split into two Cohorts: A and B. Volunteers in Cohort A were assigned to one of four dose groups receiving 50, 100, 500 and 1000ng/100μl/3mm punch biopsy. Volunteers were assigned sequentially in order of ascending dose. Within each dose group volunteers were further randomised to subgroup a, b or c. Each subject was set to receive four 3mm punch biopsies, two on each arm, and intradermal injection of avotermin, placebo or nothing (standard care).
On day 0 two 3mm punch biopsies were administered under local anaesthesia to the inner aspect of one arm of each subject following intradermal injection of avotermin, placebo or nothing. The four subjects in subgroup a received avotermin to one punch biopsy and placebo to the other. The four subjects in subgroup b received avotermin to one punch biopsy and standard care only to the other. The one subject in subgroup c was administered with intradermal placebo to one biopsy and standard care only to the other. 24 h later a further application of intradermal avotermin, placebo or nothing was applied.
While arm 1 was used as a study arm, arm 2 was used for safety procedures. Subjects were then randomised to return on Day 3 or 7 for excision of the first two punch biopsies. At the same time two punch biopsies and the same treatment regime was carried out on the second arm. These were dosed again 24 h later and all were excised on Day 10.
After determining safety and toleration of all doses in Cohort A, new subjects were assigned to Cohort B. These were allocated in ascending order to groups that would receive 1, 10, 50 and 100μg/100μl/3mm punch biopsy, following the same procedures that were used for Cohort A. Only after the first three groups reached Day 10 and the safety data was analysed would the final volunteers be recruited to the 100μg group.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Avotermin, Avotermin, Avotermin, Avotermin, Avotermin, Avotermin, Placebo (vehicle)
Renovo Clinical Trials Unit
Published on BioPortfolio: 2014-08-27T03:19:18-0400
RN1006 has been developed as a stabilized formulation of avotermin which, when dosed once in pre-clinical studies in animals, has shown comparable scar improvement efficacy to the standard...
The purpose of this study is to further determine the safety and toleration of intradermal avotermin (Juvista), confirm accelerated healing and investigate genomic expression profiles
The purpose of this study is to investigate the dosing frequency, wound healing (re-epithelialisation) and anti-scarring effects of one, three and five applications of two concentrations o...
The purpose of this study is to investigate the accelerated-healing potential of injection or injection plus topical application of Juvista to minor split skin grafts (SSG).
This trial is to determine whether Juvista can prevent scar formation or improve the appearance of scars following scar revision surgery. The trial will involve comparing Juvista to placeb...
A road-rage altercation occurred between two vehicle drivers. The driver of vehicle 1 stopped and allegedly fired two shots from within his vehicle over the heads of the driver and passenger of vehicl...
This study aims to develop a time-varying mixed logit model for the vehicle merging behavior in work zone merging areas during the merging implementation period from the time of starting a merging man...
Although placebo analgesia is a well-recognized phenomenon with important clinical implications, the possibility that placebo effects occur during sleep has received little attention. This experimenta...
Placebo beverage conditions remain a key element in the methodological toolkit for alcohol researchers interested in evaluating pharmacological and nonpharmacological factors influencing the effects o...
Recent evidence indicates that placebo effects can occur even when patients know that they are taking a placebo, termed the open-label placebo effect.
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
A vehicle equipped for transporting patients in need of emergency care.
Operating a motor vehicle while impaired by alcohol or other drugs including those prescribed by physicians.
A polyvinyl polymer of variable molecular weight; used as suspending and dispersing agent and vehicle for pharmaceuticals; also used as blood volume expander.
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase 'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...