The Experts below are selected from a list of 39 Experts worldwide ranked by ideXlab platform
Leon H Kircik - One of the best experts on this subject based on the ideXlab platform.
-
transitioning from brand to generic with topical products and the importance of maintaining the formulation and therapeutic profiles of the original product focus on Clocortolone Pivalate 0 1 cream
Journal of Drugs in Dermatology, 2014Co-Authors: Del Rosso Jq, Leon H KircikAbstract:: Topical corticosteroids (TCSs) are a major part of the foundation of treatment for a wide variety of eczematous and inflammatory skin disorders in both adults and children. Mid-potency TCSs represent an important category as they are often used to treat eczematous dermatoses, such as atopic dermatitis. The TCS product must effectively release the active ingredient and promote cutaneous penetration so that therapeutic activity can occur. As many topical products eventually become available as generic formulations, it is important to recognize that although the active ingredient and its concentration are the same, the vehicle excipients may differ significantly, occasionally leading to potential differences in irritancy, in allergenicity, in effects on epidermal permeability barrier function, and, possibly, in efficacy. Clocortolone Pivalate 0.1% cream is a mid-potency TCS formulated in an emollient formulation that has been shown to be effective and well-tolerated in the management of several corticosteroid-responsive dermatoses. This article outlines the pharmacologic and clinical data achieved with the original brand formulation of Clocortolone Pivalate 0.1% cream, and discusses the establishment of an authorized generic formulation that is identical in formulation to the original brand.
-
A study to assess the occlusivity and moisturization potential of three topical corticosteroid products using the skin trauma after razor shaving (STARS) bioassay.
Journal of Drugs in Dermatology, 2014Co-Authors: Leon H KircikAbstract:Abstract Dysfunction of the epidermal barrier is generally considered a precursor of cutaneous inflammation that can directly contribute to the pathogenesis of skin diseases, notably atopic dermatitis (AD). We also know that topical corticosteroids may actually impair the epidermal barrier by interfering with epidermal lipid synthesis. Therefore, it is important to utilize topical corticosteroids in vehicles that will help at least to enhance the already disrupted epidermal barrier in atopic dermatitis patients. Two studies of identical design were conducted to determine and compare the occlusivity and moisturizing potential of three topical corticosteroid products when applied to skin whose barrier integrity has been disrupted by dry shaving. Findings in both studies showed the Clocortolone Pivalate cream decreased TEWL better than non-treatment or treatment with hydrocortisone butyrate lotion. Skin surface hydration increased significantly (P
-
Clocortolone Pivalate a topical corticosteroid with a unique structure
Journal of Drugs in Dermatology, 2013Co-Authors: Leon H KircikAbstract:: As the accumulated clinical evidence and experience to be presented in the next several pages demonstrate, the unique engineering of the Clocortolone Pivalate molecule balances potency with documented efficacy and a favorable safety profile. Clocortolone Pivalate 0.1% cream is a well-formulated and versatile therapeutic option to consider for many of our patients with steroid-responsive dermatoses.
-
the role of a midpotency topical corticosteroid and the clinical relevance of formulation characteristics in the management of commonly encountered eczematous and inflammatory dermatoses in adults and children focus on the pharmacologic properties of
Journal of Drugs in Dermatology, 2013Co-Authors: James Q Del Rosso, Leon H KircikAbstract:: Midpotency topical corticosteroids (TCSs) are frequently used for the treatment of common eczematous and inflammatory skin disorders in both adults and children. There are several commercially available products in this category, and many vehicles and formulations for the clinician to choose from. Clocortolone Pivalate 0.1% cream is a midpotency TCS formulated in an emollient formulation that has been shown to be effective and well tolerated when used appropriately in the management of several corticosteroid-responsive dermatoses. This article discusses the physiochemical properties of the compound; the characteristics of its emollient cream formulation; the functions of individual excipients; and the efficacy, tolerability, and safety data supporting its use in adults and children, including for facial involvement.
-
the treatment of inflammatory facial dermatoses with topical corticosteroids focus on Clocortolone Pivalate 0 1 cream
Journal of Drugs in Dermatology, 2012Co-Authors: Leon H Kircik, Del Rosso JqAbstract:OBJECTIVE: Study results evaluating the efficacy and safety of Clocortolone Pivalate 0.1% cream in the treatment of adults, young children, and infants with inflammatory facial dermatoses are reported in this article. Clocortolone Pivalate 0.1% cream, indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, is a mid-potency topical corticosteroid (Class 4) that has been studied and used extensively to treat a variety of corticosteroid-responsive inflammatory dermatoses, many of which often involve facial skin in both adults and children. METHODS: Clocortolone Pivalate 0.01% cream was applied to affected facial skin in subjects presenting with seborrheic dermatitis, contact dermatitis, atopic dermatitis, or psoriasis. Application was completed three times daily for 21 days. Assessments of erythema, edema, transudation, lichenification, scaling, pruritus and/or pain were completed at baseline and Days 4, 7, 14, and 21. Overall therapeutic response was assessed at all follow-up visits. Forty-nine subjects were entered, ranging in age from 1 month to 88 years of age. Thirty-eight subjects completed the studies, with 11 subjects lost to follow-up after the first visit. Individuals between the ages of 13 and 19 years were pre-emptively excluded to avoid potential application of a corticosteroid to acne-affected or acne-prone skin. RESULTS: Treatment with Clocortolone Pivalate 0.1% cream resulted in decreases in erythema, edema, transudation, lichenification, scaling, and pruritus/pain in 76% of treated study subjects. The overall therapeutic response in approximately two-thirds of the subjects (68%) was rated as good to excellent. There were 7 adverse events noted over the course of the study that were judged to be related to treatment, all of which were cutaneous and localized to the site of application (acneiform eruptions, burning, and folliculitis). CONCLUSION: Clocortolone Pivalate 0.1% cream was effective in relieving the signs and symptoms of corticosteroid-responsive inflammatory dermatoses involving facial skin, including seborrheic dermatitis, contact dermatitis, atopic dermatitis, and psoriasis. Overall, the safety profile was favorable and devoid of any treatment-related serious adverse events.
Del Rosso Jq - One of the best experts on this subject based on the ideXlab platform.
-
transitioning from brand to generic with topical products and the importance of maintaining the formulation and therapeutic profiles of the original product focus on Clocortolone Pivalate 0 1 cream
Journal of Drugs in Dermatology, 2014Co-Authors: Del Rosso Jq, Leon H KircikAbstract:: Topical corticosteroids (TCSs) are a major part of the foundation of treatment for a wide variety of eczematous and inflammatory skin disorders in both adults and children. Mid-potency TCSs represent an important category as they are often used to treat eczematous dermatoses, such as atopic dermatitis. The TCS product must effectively release the active ingredient and promote cutaneous penetration so that therapeutic activity can occur. As many topical products eventually become available as generic formulations, it is important to recognize that although the active ingredient and its concentration are the same, the vehicle excipients may differ significantly, occasionally leading to potential differences in irritancy, in allergenicity, in effects on epidermal permeability barrier function, and, possibly, in efficacy. Clocortolone Pivalate 0.1% cream is a mid-potency TCS formulated in an emollient formulation that has been shown to be effective and well-tolerated in the management of several corticosteroid-responsive dermatoses. This article outlines the pharmacologic and clinical data achieved with the original brand formulation of Clocortolone Pivalate 0.1% cream, and discusses the establishment of an authorized generic formulation that is identical in formulation to the original brand.
-
the treatment of inflammatory facial dermatoses with topical corticosteroids focus on Clocortolone Pivalate 0 1 cream
Journal of Drugs in Dermatology, 2012Co-Authors: Leon H Kircik, Del Rosso JqAbstract:OBJECTIVE: Study results evaluating the efficacy and safety of Clocortolone Pivalate 0.1% cream in the treatment of adults, young children, and infants with inflammatory facial dermatoses are reported in this article. Clocortolone Pivalate 0.1% cream, indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, is a mid-potency topical corticosteroid (Class 4) that has been studied and used extensively to treat a variety of corticosteroid-responsive inflammatory dermatoses, many of which often involve facial skin in both adults and children. METHODS: Clocortolone Pivalate 0.01% cream was applied to affected facial skin in subjects presenting with seborrheic dermatitis, contact dermatitis, atopic dermatitis, or psoriasis. Application was completed three times daily for 21 days. Assessments of erythema, edema, transudation, lichenification, scaling, pruritus and/or pain were completed at baseline and Days 4, 7, 14, and 21. Overall therapeutic response was assessed at all follow-up visits. Forty-nine subjects were entered, ranging in age from 1 month to 88 years of age. Thirty-eight subjects completed the studies, with 11 subjects lost to follow-up after the first visit. Individuals between the ages of 13 and 19 years were pre-emptively excluded to avoid potential application of a corticosteroid to acne-affected or acne-prone skin. RESULTS: Treatment with Clocortolone Pivalate 0.1% cream resulted in decreases in erythema, edema, transudation, lichenification, scaling, and pruritus/pain in 76% of treated study subjects. The overall therapeutic response in approximately two-thirds of the subjects (68%) was rated as good to excellent. There were 7 adverse events noted over the course of the study that were judged to be related to treatment, all of which were cutaneous and localized to the site of application (acneiform eruptions, burning, and folliculitis). CONCLUSION: Clocortolone Pivalate 0.1% cream was effective in relieving the signs and symptoms of corticosteroid-responsive inflammatory dermatoses involving facial skin, including seborrheic dermatitis, contact dermatitis, atopic dermatitis, and psoriasis. Overall, the safety profile was favorable and devoid of any treatment-related serious adverse events.
-
a comprehensive review of Clocortolone Pivalate 0 1 cream structural development formulation characteristics and studies supporting treatment of corticosteroid responsive dermatoses
The Journal of clinical and aesthetic dermatology, 2012Co-Authors: Del Rosso Jq, Leon H KircikAbstract:Clocortolone Pivalate is a mid-potency topical corticosteroid available as a 0.1% emollient cream approved by the United States Food and Drug Aministration for use in the treatment of corticosteroid-responsive dermatoses. The vehicle is formulated for application to a variety of corticosteroid-responsive skin disorders, including those with inflamed and fissured skin, such as eczematous dermatoses. Hence, the potency of the formulation and its vehicle characteristics are important when treating disorders, such as atopic dermatitis and other eczematous dermatoses, which are prone to cutaneous irritation and skin sensitivity to exogenously applied agents. As both localized and diffuse eczematous dermatoses and seborrheic dermatitis are common in pediatric patients (including infants) as well as in adults, the fact that Clocortolone Pivalate 0.1% cream has no age restriction related to its use according to United States Food and Drug Aministration-approved product labeling is important to recognize. The chemical structure of Clocortolone Pivalate is a unique design that provides high lipid solubility. Highly lipophilic topical corticosteroids exhibit augmented penetration through the stratum corneum, which provides higher epidermal concentrations. It has been reported that the structural characteristics of this molecule enhance its potency without increasing the potential for topical corticosteroid-related adverse effects. Clocortolone Pivalate 0.1% cream has been studied in randomized, controlled trials of patients with atopic dermatitis and other eczematous dermatoses, psoriasis vulgaris, contact dermatitis, and seborrheic dermatitis. It has been shown to be more effective as monotherapy in the treatment of these corticosteroid-responsive dermatoses than the vehicle. Its efficacy and safety in pediatric patients and patients with facial dermatoses have also been demonstrated. Patients using Clocortolone Pivalate 0.1% topical cream in clinical trials had a low rate of adverse events, which were primarily minor application-site reactions. Systemic reactions related to the drug were not observed in these trials. Clinical studies of patients with corticosteroid-responsive dermatological conditions have found that Clocortolone Pivalate 0.1% cream is an effective class 4 topical corticosteroid with a favorable safety profile.
Baldeep Kaur Mann - One of the best experts on this subject based on the ideXlab platform.
-
clinical utility of Clocortolone Pivalate for the treatment of corticosteroid responsive skin disorders a systematic review
Clinical Cosmetic and Investigational Dermatology, 2012Co-Authors: Sanjay Singh, Baldeep Kaur MannAbstract:Clocortolone Pivalate 0.1% cream is a class IV mid-strength topical glucocorticoid. After topical application the glucocorticoid achieves higher concentration in inflamed skin compared with normal skin. Furthermore, pharmacologic studies have shown that there is little systemic absorption of Clocortolone Pivalate and hence no adrenal suppression. Systematic review was performed to evaluate the efficacy and safety of the glucocorticoid. PubMed, the Cochrane Library, and individual websites of the top 20 dermatology journals were searched using a defined strategy. Following the selection criteria, eight clinical trials were selected, of which five were randomized controlled trials. The trials mainly included patients with atopic dermatitis and eczemas. Quality appraisal of randomized controlled trials was done using the Delphi list, which showed that the trials had weaknesses in several items. The results of the systematic review tend to show that Clocortolone Pivalate cream is generally effective with early onset of action and has a good safety profile in the treatment of these conditions. Further studies comparing this glucocorticoid with other glucocorticoids and treatments in steroid-responsive dermatoses are desirable.
Sanjay Singh - One of the best experts on this subject based on the ideXlab platform.
-
clinical utility of Clocortolone Pivalate for the treatment of corticosteroid responsive skin disorders a systematic review
Clinical Cosmetic and Investigational Dermatology, 2012Co-Authors: Sanjay Singh, Baldeep Kaur MannAbstract:Clocortolone Pivalate 0.1% cream is a class IV mid-strength topical glucocorticoid. After topical application the glucocorticoid achieves higher concentration in inflamed skin compared with normal skin. Furthermore, pharmacologic studies have shown that there is little systemic absorption of Clocortolone Pivalate and hence no adrenal suppression. Systematic review was performed to evaluate the efficacy and safety of the glucocorticoid. PubMed, the Cochrane Library, and individual websites of the top 20 dermatology journals were searched using a defined strategy. Following the selection criteria, eight clinical trials were selected, of which five were randomized controlled trials. The trials mainly included patients with atopic dermatitis and eczemas. Quality appraisal of randomized controlled trials was done using the Delphi list, which showed that the trials had weaknesses in several items. The results of the systematic review tend to show that Clocortolone Pivalate cream is generally effective with early onset of action and has a good safety profile in the treatment of these conditions. Further studies comparing this glucocorticoid with other glucocorticoids and treatments in steroid-responsive dermatoses are desirable.
Hugh W. Thompson - One of the best experts on this subject based on the ideXlab platform.
-
9α-Chloro-16α-methyl-3,11-dioxoandrosta-1,4,6-triene-17β-carboxylic acid pinacolone solvate: catemeric hydrogen bonding and pinacolone solvation in a steroidal diketo acid derived from a commercial glucocorticoid
Acta Crystallographica Section E-structure Reports Online, 2007Co-Authors: Irum Azim, Mark Davison, Marisa Devita Dufort, Roger A. Lalancette, Hugh W. ThompsonAbstract:The title ketocarboxylic acid, synthesized from the anti-inflammatory Clocortolone Pivalate, crystallizes as C21H23ClO4·C6H12O, with one molecule of steroid and one of 3,3-dimethylbutanone per asymmetric unit. The carboxyl group is highly ordered and the steroid molecules form translational carboxyl-to-ketone hydrogen-bonding catemers [O⋯O = 2.682 (3) A and O—H⋯O = 158°] that utilize the 3-ketone group, with one chain proceeding in the [110] direction and the other in the [\overline{1}10] direction. One close intermolecular C—H⋯O=C contact is present, which involves the solvent O atom, but neither it nor the Cl atom nor the 11-ketone group play any role in the classical hydrogen bonding.