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Safety Study in Patients With Scalp Psoriasis Suppression Following Maximal Use Treatment With Topical Product

NCT ID: NCT02933502

Last Updated: 2018-12-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-11

Study Completion Date

2018-01-02

Brief Summary

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An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use DSXS topical product (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Moderate to SevereScalp Psoriasis

Detailed Description

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* Evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe scalp psoriasis.
* Evaluate the efficacy parameters and adverse event (AE) profiles of DSXS topical product administered to patients with moderate to severe scalp psoriasis.

Conditions

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Scalp Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DSXS topical product

treatment with DSXS once daily for 28 days

Group Type EXPERIMENTAL

DSXS topical product

Intervention Type DRUG

treatment daily for 28 days

Interventions

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DSXS topical product

treatment daily for 28 days

Intervention Type DRUG

Other Intervention Names

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Active

Eligibility Criteria

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Inclusion Criteria

* Male or non-pregnant, non-lactating females 12-17 years of age.

Exclusion Criteria

* Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novum Pharmaceutical Research Services

Role: STUDY_CHAIR

http://www.novumprs.com/contact

Locations

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Taro Pharmaceuticals USA Inc.

Hawthorne, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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DSXS 1538b

Identifier Type: -

Identifier Source: org_study_id