Topics

Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis

2019-09-20 03:46:43 | BioPortfolio

Summary

This is a Phase 2a, randomized, double blind, vehicle controlled, parallel group, proof of concept study that will include participants with stasis dermatitis without active skin ulceration, who will receive crisaborole ointment 2% or vehicle twice daily for 6 weeks.

Description

Study C3291038 is a Phase 2a, randomized, double-blind, vehicle-controlled, parallel-group, proof of concept study to evaluate the efficacy, safety, and local tolerability of 6 weeks of treatment with crisaborole in adult participants with SD without active skin ulceration. Approximately 82 eligible participants will be randomized into the double blind treatment period in a 1:1 ratio to receive crisaborole ointment, 2% or vehicle twice daily for 6 weeks.

The study will recruit male and female participants aged ≥ 45 years with a clinical diagnosis of SD.

The total duration of participation in the study will be up to 14 weeks, including up to 4 weeks for screening, a 6 week double blind treatment period, and a follow-up period of 4 weeks after treatment completion.

Study enrollment and management will be de centralized, where participants do not visit an investigator or a clinic for clinical assessment. The participants will participate in the study at home. The sponsor (or designee) will provide home visits by qualified home visit practitioners (HVP), remote contact by telemedicine (or telephone), and clinical database electronic case report forms (eCRFs), eDiary, and other electronic data entries from 3rd party vendors for study data collection.

Study Design

Conditions

Stasis Dermatitis

Intervention

crisaborole ointment, vehicle ointment

Status

Not yet recruiting

Source

Pfizer

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-20T03:46:43-0400

Clinical Trials [1102 Associated Clinical Trials listed on BioPortfolio]

Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis

This study is being conducted to characterize the mechanism of action of crisaborole ointment 2%, by evaluation of efficacy and changes in key skin biomarkers in atopic dermatitis (AD) les...

A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD

This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%; crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice daily (BID)...

Study to Assess Efficacy and Safety of Two Regimens of Crisaborole Ointment 2% in Japanese Participants Aged ≥2 Years With Mild to Moderate Atopic Dermatitis

This is a Phase 2b, multi-center, randomized, double-blind, vehicle-controlled, intraparticipant study to evaluate efficacy and safety of two regimens of crisaborole ointment 2% in Japanes...

Different Application Rates of Crisaborole Ointment 2% in Adults With Mild to Moderate Atopic Dermatitis

This study is being conducted to evaluate the efficacy and safety of 3 different application rates of topically applied Crisaborole ointment 2% over vehicle in adults with mild to moderate...

A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis

This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of...

PubMed Articles [1384 Associated PubMed Articles listed on BioPortfolio]

Ex vivo (human skin) and in vivo (minipig) permeation of propylene glycol applied as topical crisaborole ointment, 2.

Crisaborole ointment, 2%, is a non-steroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate atopic dermatitis. It contains 9% w/w propylene glycol (PG). Although PG is generally c...

Crisaborole and atopic dermatitis skin biomarkers: an intrapatient randomized trial.

Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the treatment of mild-to-moderate atopic dermatitis (AD). The mechanism of action (MOA) of crisaborole and its effe...

Phase 1 study of crisaborole in Japanese healthy volunteers and patients with atopic dermatitis.

Crisaborole ointment, 2%, is a non-steroidal phosphodiesterase 4 inhibitor for the treatment of mild to moderate atopic dermatitis (AD). This parallel-cohort, phase 1 study was conducted to investigat...

Crisaborole 2% ointment for the treatment of intertriginous, anogenital, and facial psoriasis: a double-blind, randomized, vehicle-controlled trial.

Psoriasis of the intertriginous, anogenital, and facial regions remains a therapeutic challenge, with current algorithms lacking a topical agent that exhibits both high efficacy and minimal side effec...

Calcipotriol ointment shows comparable efficacy to topical steroids in chronic hand eczema.

Topical potent corticosteroids are the mainstay of treatment for chronic hand eczema (CHE). However, there are numerous adverse effects associated with the chronic use of topical corticosteroids. Calc...

Medical and Biotech [MESH] Definitions

Semisolid preparations used topically for protective emollient effects or as a vehicle for local administration of medications. Ointment bases are various mixtures of fats, waxes, animal and plant oils and solid and liquid hydrocarbons.

A mixture of liquid hydrocarbons obtained from petroleum. It is used as laxative, lubricant, ointment base, and emollient.

A colloidal system of semisolid hydrocarbons obtained from PETROLEUM. It is used as an ointment base, topical protectant, and lubricant.

Non-ionic surfactant of the polyethylene glycol family. It is used as a solubilizer and emulsifying agent in foods, cosmetics, and pharmaceuticals, often as an ointment base, and also as a research tool.

A poly(dimethylsiloxane) which is a polymer of 200-350 units of dimethylsiloxane, along with added silica gel. It is used as an antiflatulent, surfactant, and ointment base.

More From BioPortfolio on "Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis"

Quick Search

Relevant Topics

Allergies
The term allergy is used to describe a response, within the body, to a substance, which is not necessarily harmful in itself, but results in an immune response and a reaction that causes symptoms and disease in a predisposed person, which in turn can cau...

Wound management
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...

Dermatology
Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...


Searches Linking to this Trial