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

Taro Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Scalp Psoriasis

Treatments: Drug: DSXS topical product

Study type: Interventional

Funder types: Industry

Identifiers

NCT02933502

DSXS 1538b

Details and patient eligibility

About

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

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: 3 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

DSXS topical product

Experimental group

Description:

treatment with DSXS once daily for 28 days

Treatment:

Drug: DSXS topical product