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OpenTrials
Completed

NCT Number: NCT02933528

Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS

An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment with DSXS .

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

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

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.

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 18 years of age or older.
  • IRE-approved, signed informed consent form that meets all criteria of current FDA regulations.

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.

Treatment and study plan

DSXS topical product

Drug

once daily for 28 days

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 stimulation

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 Maximal Use Treatment With DSXS in Patients With Moderate to Severe Scalp Psoriasis

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 14, 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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