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

Taro Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: DSXS Topical product

Study type: Interventional

Funder types: Industry

Identifiers

NCT02933528

DSXS 1538a

Details and patient eligibility

About

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

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Dsxs topical product

Experimental group

Description:

treatment with DSXS once daily for 28 days

Treatment:

Drug: DSXS Topical product