Cutivate Lotion HPA Axis Pediatric Study

Fougera Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: Fluticasone propionate 0.05% lotion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00546000

ALT 0434-01-01

Details and patient eligibility

About

A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.

Enrollment: 56 patients

Sex: All

Ages: 3 to 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects are 3-12 months of age
• Subjects diagnosed with Atopic Dermatitis (AD) and have ≥35% of Body Surface Area
• Subjects meet protocol specific AD signs and symptom severity score

Exclusion criteria

• Subjects with conditions effecting the HPA Axis
• Subjects with clinically significant systemic disease
• Subjects who require treatment with systemic or topical retinoids during the study
• Subjects who have been treated with various chronic therapies identified in the protocol
• Subjects who have received other investigational drug treatment within 30 days prior to study entry

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

1

Experimental group

Description:

Receive between 22 and 29 days of Cutivate lotion treatment

Treatment:

Drug: Fluticasone propionate 0.05% lotion