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

Taro Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: DSXS topical

Study type: Interventional

Funder types: Industry

Identifiers

NCT02932891

DSXS 1502a

Details and patient eligibility

About

An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment with DSXS in Patients with Atopic Dermatitis

Full description

To evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe atopic dermatitis.

Enrollment: 28 patients

Sex: All

Ages: 6 months to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Parent/legal guardian has signed informed consent form, which 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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28 participants in 1 patient group

DSXS topical

Experimental group

Description:

active treatment

Treatment:

Drug: DSXS topical