PROCTOFOAM HC SUMMARY
proctofoam® HC
(hydrocortisone acetate 1% and pramoxine hydrochloride 1%)
topical aerosol
Rx Only
Proctofoam®-HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) is a topical aerosol foam for anal use containing hydrocortisone acetate 1% and pramoxine hydrochloride 1% in a hydrophilic base containing cetyl alcohol, emulsifying wax, methylparaben, polyoxyethylene-10-stearyl ether, propylene glycol, propylparaben, purified water, trolamine and inert propellants: isobutane and propane.Proctofoam®-HC contains a synthetic corticosteroid used as an anti-inflammatory/antipruritic agent and a local anesthetic.
Proctofoam®-HC is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region.
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NEWS HIGHLIGHTS
Clinical Trials Related to Proctofoam HC (Hydrocortisone / Pramoxine Rectal)
The Safety of Proctofoam-HC in the Third Trimester of Pregnancy [Recruiting]
Children's Exposures/Health Effects/Diesel Exhaust [Recruiting]
The contribution of diesel exhaust (DE) to health, especially children's health, is of
tremendous public health interest. DE has been associated with worsening asthma and
allergies, among other important health effects. Reducing DE exposures has become a major
regulatory initiative, and federal, state, and local jurisdictions are investing hundreds of
millions of dollars in retrofitting diesel engines in school buses and other changes to
reach this goal.
The U. S. Environmental Protection Agency's recent regulations require all on-road diesel
vehicles to change to low emission engines and ultra-low-sulfur fuels by 2007 (US EPA '00).
In spring 2003, the U. S. EPA announced a nationwide voluntary school bus retrofit
initiative. In July 2003, the Washington Legislature enacted a statewide "Diesel Solutions"
program that provides 25 million dollars by 2008 to retrofit school diesel buses with
cleaner burning engines and fuels, making it one of the largest and most active voluntary
school bus retrofit program in the country. If risk assessment estimates are accurate, these
changes will have a large public health impact, especially on children who ride school buses
daily. However, no studies to-date have rigorously examined school children's exposure to
diesel exhaust (DE) and its health effects, nor such a significant change in vehicular
pollution control. We propose to seize this opportunity of a large natural experiment taking
place in the Puget Sound area and conduct a study to assess health effects from diesel bus
exhaust before and after the retrofit of diesel bus fleets between 2005 and 2007. The
specific aims of the study are to:
1. Determine whether asthmatic children changing to retrofitted buses with cleaner fuels
and engines have a reduction in sub-clinical and clinical asthma severity.
2. Determine if increased levels of DE exposure lead to an increase in acute clinical and
sub-clinical features of asthma in children.
3. Quantify the levels and changes in particle and toxic gas exposures to DE in 3 groups
of children commuting to school by retrofitted buses or private cars, old diesel buses
to be retrofitted later, and old diesel buses through the study.
Sub-aim 3: Use the time-activity information, personal exposure measurements, and on-bus
monitoring data to construct an exposure model to predict individual exposures to DE for all
subjects.
Bowel Preparation and Pelvic Organ Prolapse Surgery [Recruiting]
The purpose of this study is to find out if performing a bowel preparation prior to pelvic
organ prolapse surgery has any effect on the return of bowel function after surgery.
Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy [Not yet recruiting]
Study hypothesis The overall aim of this study is to compare two bowel preparations that are
used prior to a colonoscopy procedure.
The principal research questions are:
1. Does the use of a low residue diet increase patient concordance to the bowel
preparation instructions?
2. Does the use of a low residue diet decrease the adequacy of assessment of the mucosa?
3. Does the use of a low residue diet increase the willingness of patients to undertake
repeated examination as is required for disease follow−up?
4. Does body weight affect perceived tolerability of either group?
MRI/MRSI in Risk Assessment of Prostate Cancer Patients [Recruiting]
The purpose of this study is to see if magnetic resonance imaging (MRI) and magnetic
resonance spectroscopic imaging (MRSI) can tell which patients with prostate cancer are at a
low risk for their cancer growing and spreading. Magnetic resonance methods use magnets and
radio waves to take pictures of body structure (MRI) and to measure amounts of important
chemicals within the body (MRSI). This study will look at the structural and chemical
properties of prostates before undergoing treatment. Hopefully, doctors will be able to use
this method before making treatment decisions for patients with newly diagnosed cancer of
the prostate. This study will continue our work to assess the value of MRI/MRSI in
addressing what is currently one of the greatest clinical challenges in the management of
prostate cancer: the identification of low-risk organ-confined prostate cancer that can be
managed expectantly with deferred treatment.
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