Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population

Fougera Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis; Psoriasis

Treatments: Drug: Pandel Cream 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01137032

ALT 0153-01-1

Details and patient eligibility

About

The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface area.

Enrollment: 19 patients

Sex: All

Ages: 3+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of psoriasis or atopic dermatitis involving more than 20% of body surface area
• Good health with the exception of psoriasis or atopic dermatitis

Exclusion criteria

• Any disease affecting the HPA-axis
• Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Pandel Cream 0.1%

Experimental group

Description:

Pandel Cream 0.1%

Treatment:

Drug: Pandel Cream 0.1%