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OpenTrials
Completed

NCT Number: NCT02932878

An Open Label, Safety Study to Assess the Potential for Adrenal Suppression

An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment with DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Plaque Psoriasis

Completed

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Key information

Conditions

Plaque Psoriasis

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Taro Pharmaceuticals USA Inc.

Hawthorne, New York, 10532, United States

About this study

To evaluate the potential of DSXS to suppress HPA axis function in patients with mild to moderate plaque psoriasis.

To evaluate the efficacy parameters and adverse event (AE) profile of DSXS administered to patients with mild to moderate plaque psoriasis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or non pregnant, non lactating females

Exclusion criteria

  • Patients under 2 years of age

Treatment and study plan

DSXS topical

Drug

topical treatment

Other names: active

Primary outcomes

  1. Proportion of Patients in the Study With HPA Axis Suppression

    Time frame: 28 Days

    Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS Topical Product in Patients With Plaque Psoriasis

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 13, 2016
Registry last updated
Dec 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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