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A Randomized Double Blind Vehicle Controlled Dose Ranging Parallel Design Multiple Site Clinical Study

Information source: Taro Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Plaque Psoriasis

Intervention: Desoximetasone Shampoo 0.25% (Drug); Placebo Shampoo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Taro Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Natalie Yantovskiy, Study Director, Affiliation: Taro Pharmaceuticals USA, Inc.

Overall contact:
Taro Pharmaceuticals USA, Phone: 914-345-9001


The objectives of this study are to evaluate the therapeutic efficacy and safety of Desoximetasone 0. 25% Shampoo and a Placebo Shampoo in patients with moderate to severe scalp psoriasis.

Clinical Details

Official title: A Randomized Double Blind Vehicle Controlled Dose Ranging Multiple Site Phase 2 Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone 0.25% Shampoo in Patients With Moderate to Severe Scalp Psoriasis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The proportion of patients in each treatment group that have clinical success at Day 28, which is defined by a Investigator's Global Assessment score of 0 or 1.

Detailed description: This randomized, double-blind, vehicle-controlled, dose-ranging, parallel-group multi-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, desoximetasone 0. 25% Shampoo, for the treatment of moderate to severe scalp psoriasis at different application times up to 30 minutes. Multiple treatment durations will be evaluated to determine the optimum duration of application, which will be used to design subsequent Phase-III efficacy studies. Additionally the active formulation will be assessed for superiority to a Placebo (vehicle) shampoo at each of the four application times


Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Male or non-pregnant, non-lactating females age 12 and older.

- If female of child bearing potential, have a negative urine pregnancy test at

baseline/randomization visits and prepared to abstain from sexual intercourse or use a reliable method of contraception during the study.

- Signed informed consent form. For patients under the age of majority in the state the

study is being conducted, the parent or legal guardian signs consent and child signs a patient assent form.

- Clinical diagnosis of moderate to severe scalp psoriasis, defined by a Investigator's

Global Assessment score of at least 3 at screening.

- Is in good general health.

Exclusion Criteria:

- Under 12 years of age.

- Females who are pregnant, lactating or likely to become pregnant during the study.

- Patients whose scalp and/or non-scalp psoriasis necessitates systemic or other

concomitant topical therapies during the study.

- Has a scalp skin condition that would interfere with the diagnosis or assessment of

plaque psoriasis of the scalp.

- Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the

treatment areas, which could interfere with the rating of efficacy parameters.

- History of psoriasis unresponsive to topical treatments.

- Current immunosuppression.

- Have used the following on the scalp within 2 weeks of screening: topical

corticosteroids, topical anti-psoriatic medication, topical retinoids.

- Have used within 2 weeks of screening beta blockers, lithium preparations,

anti-malarial agents and non-steroidal anti-inflammatory drugs.

- Have used topical corticosteroids on the body within 2 weeks of randomization.

- Use within six months prior to baseline a biologic treatment for psoriasis.

- Use within three months prior to baseline of: chemotherapy or radiation therapy.

- Use within one month prior to baseline of: systemic steroids, systemic antibiotics,

systemic antipsoriatic treatment, psoralen and ultraviolet A therapy, ultraviolet B therapy, systemic anti-inflammatory agents.

- Have used systemic retinoids within 16 weeks of randomization.

- Use within two months prior to baseline of any immunosuppressive drugs or oral


- Changed brands/types or frequency of use of routine hair care products within 14 days

prior to baseline, or intend to change during the study.

- Received any drug as part of a research study within 30 days prior to dosing.

- Significant history or current evidence of chronic infectious disease, system

disorder, organ disorder or other medical condition that would place the study participant at undue risk by participation.

- History of allergy or hypersensitivity to desoximetasone or history of any drug

hypersensitivity or intolerance which would compromise the safety of the patient or the study.

- Current evidence of drug abuse or history of drug abuse within 1 year before the

first dose, including history of alcohol abuse or active alcoholism.

- Inability to understand the protocol requirements, instructions, and study-related

restrictions, the nature, scope, and possible consequences of the clinical study.

- Unlikely to comply with the protocol requirements, instructions, and study-related


- Is a member of the investigational study staff or a member of the family of the

investigational study staff.

- Previous participation in this study.

Locations and Contacts

Taro Pharmaceuticals USA, Phone: 914-345-9001

Taro Pharmaceuticals USA, Inc., Hawthorne, New York 10532, United States; Recruiting
Natalie Yantovskiy
Additional Information

Starting date: March 2015
Last updated: April 8, 2015

Page last updated: August 23, 2015

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