Topics

A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis

2015-12-21 06:04:21 | BioPortfolio

Summary

This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.

Description

This study will be a multicenter (approximately 30 sites), randomized, vehicle-controlled, double-blind, and parallel group design. Approximately 264 subjects with moderate to severe plaque psoriasis will be randomized to treatment with DFD-06 Cream or Vehicle Cream. Subjects will use study product twice daily for 14 days. Subject visits are scheduled at Screening, Baseline (Day 1) and Days 4, 8, and 15. Clinical determinations of disease severity will be performed using the total sign score (TSS) for the target lesion and Investigator Global Assessment (IGA) for overall severity.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Psoriasis

Intervention

DFD06 Cream, Vehicle Cream

Location

Site 116
Glendale
Arizona
United States
85308

Status

Not yet recruiting

Source

Promius Pharma, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-12-21T06:04:21-0500

Clinical Trials [1504 Associated Clinical Trials listed on BioPortfolio]

A Multi-Center, Double-Blind, Randomized, Vehicle- Controlled, Parallel-Group Study Comparing AM001 Cream, 7.5% to Vehicle Cream in the Treatment of Plaque Psoriasis

To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the treatment of plaque psoriasis

The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis

This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream 0.3% or ARQ-151 cream 0.15% or vehicle cream is applied once daily for 84 days to subjects with chro...

GSK2894512 Vehicle-Controlled Study for Adult Plaque Psoriasis

This study will evaluate the efficacy and safety of GSK2894512 cream for the topical treatment of plaque psoriasis (psoriasis) with its vehicle cream. This is a randomized, double-blind, v...

A Phase I Study to Assess Novel Cream in a Psoriasis Plaque Test

The purpose of this study is to investigate dose-response relationship, antipsoriatic efficacy and safety of different concentrations of topical formulations with AN2728 in subjects with p...

Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001)

This is a randomized, double-blind, vehicle-controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% once daily for the treatment of plaque psoriasis in ...

PubMed Articles [1338 Associated PubMed Articles listed on BioPortfolio]

A Real-World, Non-interventional Indian Study Evaluating Intensive Plant-Based Butter Moisturizing Cream in Psoriasis.

Psoriasis is estimated to affect 0.44-2.8% of the Indian population. Moisturizers are a key adjuvant psoriasis treatment strategy, but data regarding their effectiveness, safety and compliance pattern...

Irritant contact dermatitis caused by a shower cream used as a leave-on product.

Irritant contact dermatitis can be caused by exposure to numerous irritants such as water, alkalis, acids, oils and organic solvents (1). Here, we present a patient who developed severe irritant conta...

Evaluation of cytotoxicity and wound healing activity of Avicennia schaueriana in cream.

Avicennia schaueriana is found in Brazilian mangrove coast. The cytotoxicity in vitro of the Aqueous Extract of Leaves of Avicennia schaueriana (AELAs) and the healing activity of the plant in cream o...

Fludroxycortide cream as an alternative therapy for actinic cheilitis.

The objective of the study is to assess, by clinical follow-up, the efficacy of the dermatological cream Fludroxycortide 0.125 mg/g (Drenison®) in the treatment of actinic cheilitis (AC).

Significant therapeutic response to cysteamine cream in a melasma patient resistant to Kligman's formula.

L-Cysteamine is a biological antioxidant produced during the coenzyme A metabolism cycle and is naturally present in all mammalian cells. The efficacy of topical cysteamine for the treatment of melasm...

Medical and Biotech [MESH] Definitions

A frozen dairy food made from cream or butterfat, milk, sugar, and flavorings. Frozen custard and French-type ice creams also contain eggs.

A synthetic, non-steroidal estrogen structurally related to stilbestrol. It is used, usually as the cream, in the treatment of menopausal and postmenopausal symptoms.

The clarified portion of milk, cream, or butter obtained by the removal of the nonfat constituents. (from Dictionary of Food Ingredients, 4th ed., 2001)

A water-soluble medicinal preparation applied to the skin.

A corticosteroid used topically in the treatment of various skin disorders. It is usually employed as a cream or an ointment, and is also used as a polyethylene tape with an adhesive. (From Martindale, The Extra Pharmacopoeia, 30th ed, p733)

More From BioPortfolio on "A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis"

Quick Search

Relevant Topics

Psoriasis
Psoriasis is a common skin condition affecting 2-3% of the population of the United Kingdom, where the skins replacement process is sped taking 2-6 days instead of the usual 21 - 28 days for the replacement of skin cells. Patients experience an accumulat...

Alzumab (Itolizumab)
Biocon Launches ALZUMAb™ - a ‘First in Class’ Novel Biologic Treatment for Psoriasis Patients in India • ALZUMAb™-World's first novel anti-CD6 antibody developed by Biocon to address a large unmet need for th...

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