Pandel (Hydrocortisone Probutate) - Summary

PANDEL SUMMARY

pandel^® (hydrocortisone probutate cream) Cream, 0.1%

Pandel Cream contains hydrocortisone probutate, a synthetic adrenocorticosteroid, for dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents.

Pandel (hydrocortisone probutate cream) Cream, 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.

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NEWS HIGHLIGHTS

Published Studies Related to Pandel (Hydrocortisone)

Randomized, double-blind, split-side comparison study of moisturizer containing licochalcone vs. 1% hydrocortisone in the treatment of infantile seborrhoeic dermatitis. [2012]
hydrocortisone for the treatment of ISD... CONCLUSION: Moisturizer containing 0.025% licochalcone had higher cure rate

Single-blind, randomized controlled trial evaluating the treatment of facial seborrheic dermatitis with hydrocortisone 1% ointment compared with tacrolimus 0.1% ointment in adults. [2011.11.17]
BACKGROUND: Tacrolimus is a topical calcineurin inhibitor with immunomodulatory, anti-inflammatory, and fungicidal properties that may be beneficial in the treatment of facial seborrheic dermatitis. OBJECTIVES: We sought to compare the efficacy and safety of tacrolimus with standard corticosteroid treatment in adults with facial seborrheic dermatitis in a phase II, single-blind, randomized controlled trial... CONCLUSION: Tacrolimus 0.1% ointment required significantly fewer applications compared with hydrocortisone 1% ointment to achieve a comparable clinical response in adults with facial seborrheic dermatitis. Tacrolimus was generally well tolerated. Copyright (c) 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

Hydrocortisone reduces postoperative shivering following day care knee arthroscopy. [2011.10]
PURPOSE: Postoperative shivering is commonly observed in patients after general anesthesia. A double-blind randomized controlled trial was conducted in patients undergoing day care knee arthroscopy to test the hypothesis that a single intraoperative dose of hydrocortisone would prevent or attenuate postoperative shivering... CONCLUSIONS: This study shows that hydrocortisone (1-2 mg.kg(-1) iv) provides effective prophylaxis against postoperative shivering in patients undergoing day care knee arthroscopy under general anesthesia.

Comparable efficacy of a topical 0.0584% hydrocortisone aceponate spray and oral ciclosporin in treating canine atopic dermatitis. [2011.07.01]
This study compared the efficacy of a 0.0584% hydrocortisone aceponate (HCA) spray (Cortavance((R)) ; Virbac SA) and ciclosporin (Atopica((R)) ; Novartis Animal Health) in canine atopic dermatitis in a single-blind randomized controlled trial. Dogs received HCA (two sprays/100 cm(2) ; n = 24) or ciclosporin (5 mg/kg; n = 21)...

A randomised placebo-controlled trial of oral hydrocortisone for treating tobacco withdrawal symptoms. [2011.07]
RATIONALE: Many smokers experience a decline in cortisol to sub-normal levels during the first days of smoking cessation. A greater decline in cortisol is associated with more intense cigarette withdrawal symptoms, urge to smoke and relapse to smoking. Findings from an uncontrolled study suggest that glucocorticoids could ameliorate cigarette withdrawal. OBJECTIVES: We investigated whether taking oral hydrocortisone would reduce withdrawal symptoms and the desire to smoke on the first day of temporary smoking abstinence compared with placebo... CONCLUSIONS: Supplements of hydrocortisone do not reduce the desire to smoke but may ameliorate withdrawal-related depression and anxiety, although the clinical benefit is slight.

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Clinical Trials Related to Pandel (Hydrocortisone)

Adherence to Topical Hydrocortisone 17-Butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis [Active, not recruiting]
The purpose of this research study is to better understand how the study drug Locoid works when people use it to treat atopic dermatitis.

Contribution of Salivary Cortisol in the Detection of Infra-clinic Cortisol Adenoma (ACIC) [Recruiting]

Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency [Not yet recruiting]
Patients with chronic adrenal insufficiency need to adapt their hydrocortisone replacement dose in conditions of physical or psychological stress to prevent life threatening adrenal crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e. g. gastroenteritis, severe infectious disease), parenteral administration of the hydrocortisone dose is crucial. The study is conducted to offer patients the possibility to perform hydrocortisone self administration in emergency situations in a way of administration which is easy to perform and accepted by the patient. Therefore, pharmacokinetics and safety of subcutaneous hydrocortisone administration will be studied and compared to intramuscular administration.

Sensitivity of Short and Long Allele Carriers of the 5-HTTLPR to Environmental Threat Post Hydrocortisone Administration [Recruiting]
The current study will test the causal relationship between elevated levels of cortisol and the serotonin transporter gene (5-HTTLPR) as these factors influence sensitivity to environmental threat. The investigators predict that carriers of the short allele of the serotonin transporter gene who have elevated cortisol levels will be most sensitive to threatening environments, whereas carriers of the long allele who do not have elevated cortisol (placebo subjects) will be least sensitive.

Trial of Hydrocortisone for Post-Traumatic Stress Disorder (PTSD) [Recruiting]
Developing novel and effective pharmacologic interventions for this post-traumatic stress disorder is important. The investigators propose to replicate findings of an earlier published pilot study using low dose hydrocortisone as a treatment for PTSD. In order to do so in a more meaningful way, the investigators will conduct a larger but similar randomized double-blind placebo-controlled, cross-over design treatment study examining the use of low dose hydrocortisone (or placebo) for 4 weeks in combat veterans suffering from PTSD.

The investigators hypothesize that, as described by Aerni et al. (2004), administration of daily hydrocortisone will lead to a reduction in PTSD symptom severity, but particularly for re-experiencing types (e. g., flashbacks, nightmares)of symptoms. The investigators also hope to examine potential predictors and moderators of treatment response based on subjects' clinical characteristics, as well as serum cortisol and ACTH levels.

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