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Proctofoam HC (Hydrocortisone Acetate / Pramoxine Hydrochloride) - Summary

 
 



PROCTOFOAM HC SUMMARY

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.


See all Proctofoam HC indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Proctofoam HC (Hydrocortisone / Pramoxine)

The fetal safety of hydrocortisone-pramoxine (Proctofoam-HC) for the treatment of hemorrhoids in late pregnancy. [2011.02]
OBJECTIVE: Fetal safety has never been studied for any drug used in the treatment of hemorrhoids. Proctofoam-HC is a combination of a corticosteroid and a local anaesthetic that is proven effective for the treatment of hemorrhoids. The objective of this study was to assess prospectively the fetal safety of third trimester exposure to Proctofoam-HC... CONCLUSION: Proctofoam-HC is safe to use in the treatment of hemorrhoids in late pregnancy.

The effectiveness of Proctofoam-HC for treatment of hemorrhoids in late pregnancy. [2009.07]
OBJECTIVE: Currently no topical anti-hemorrhoidal agents have been studied for effectiveness in pregnancy. This study evaluated the effectiveness of Proctofoam-HC used during the last trimester of pregnancy... CONCLUSIONS: Proctofoam-HC appears to provide effective treatment of hemorrhoids in late pregnancy.

more studies >>

Clinical Trials Related to Proctofoam HC (Hydrocortisone / Pramoxine)

The Safety of Proctofoam-HC in the Third Trimester of Pregnancy [Completed]

Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis Patients [Active, not recruiting]

The Effects of Emollient Therapy on the Skin Barrier [Recruiting]
The goal of this study is to better understand what effect emollients (moisturizers) have on the skin in young children and adults. Subjects will be recruited from PI and Sub-I clinics and Oregon Health & Science University (OHSU) research opportunities website. 1. Adult and Adolescent Study:

Moisturizer Intervention - There will be 2-3 visits for this study: a screening visit,

a baseline visit, and a final visit. Adults with a history of eczema will be asked to apply one of four possible moisturizers to one arm and nothing to the other arm for four weeks. The moisturizers, which will be assigned to the subjects, include either Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, or Vaseline 100% Petroleum Jelly. Subjects can use other skin treatments as needed for their skin condition, but may not treat the arms during the study. Non-invasive tests of the skin will be made at Visit 1 and after four weeks (Visit 2). The skin measurements that will be performed are:

- Transepidermal loss (TEWL)- measures how much water is lost across the skin

barrier

- Skin Cohesion and TEWL - TEWL after 5, 10, 15, and 20 tape strips will measure

skin barrier function after tape-stripping

- Skin electrical capacitance - measures the moisture in the top layer of skin

- Skin pH - measures the acidity of the skin

- Stratum corneum cohesion assay - tape-stripping to measure the protein removed

from the top layer of skin

- Lipidomic analysis - measures the lipids, or oils, in the top layer of skin

Control - There will be 1-2 visits for this group: a screening visit and baseline

visit, which can be combined. Non-invasive tests of the skin will be taken and include the skin measurements that will be performed are the same as the Moisturizer Intervention group. 2. Pediatric Study: There will be 2-3 visits for this study: a screening visit, a baseline visit, and a final visit. Infants and toddlers between 3 months and 3 years of age without a history of skin barrier diseases will be assigned to a moisturizer, which include either Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, or Aveeno Skin Relief Moisture Repair Cream. Non-invasive tests of the skin will be made at Visit 1 and after four weeks (Visit 2).

- TEWL- measures how much water is lost across the skin barrier

- Skin electrical capacitance - measures the moisture in the top layer of skin

- Skin pH - measures the acidity of the skin

A Study to Compare QUTENZA With Pregabalin for the Treatment of Peripheral Neuropathic Pain (PNP) After 8 Weeks of Treatment [Completed]
This study is comparing the efficacy and tolerability of Qutenza with that of pregabalin in patients suffering from peripheral neuropathic pain. Treatment allocation will be to one of these treatments and the duration of the study will be about 10 weeks (assuming that from screening to treatment allocation takes 2 weeks). Participants will be asked to complete questionnaires about various aspects relating to their condition throughout the study. This study will include subjects suffering from Postherpetic Neuralgia, Peripheral Nerve Injury or Non Diabetic peripheral polyneuropathy.

A Prospective, Randomized, Three Arms, Open Label Study Comparing the Safety and Efficacy of Two Formulations of PP110 to the Active Comparator Preparation-H Cream in the Treatment of Bleeding Hemorrhoids Grades 2-3 [Completed]
Eligible patients with bleeding hemorrhoids of grade 2-3 are randomized to test-1 product (PP110 Gel), test-2 product (PP-110 medicated wipes) or control (Preparation-H cream). Test product usage: once daily, about 1-5 minutes prior to first bowel movement. Control product usage: according to label, 3-4 times daily application to rectal region. At the end of each day, subject fills a questionnaire regarding bleeding, pain, discharge, swelling, itching, discomfort and painkiller usage. Treatment is for two weeks, after which subjects fill a feedback questionnaire addressing treatment efficacy and subject satisfaction. Also, at the end of two weeks, subjects are examined by study physician who assesses hemorrhoid severity.

more trials >>


Page last updated: 2011-12-09

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