Who is sponsoring NCT00546000?

NCT00546000 is sponsored by Fougera Pharmaceuticals Inc..

What condition does NCT00546000 study?

NCT00546000 studies Atopic Dermatitis.

What drugs are being tested in NCT00546000?

Interventions: Fluticasone propionate 0.05% lotion.

What is the status of NCT00546000?

NCT00546000 is currently COMPLETED.

Last reviewed 2014-06-25 · How we verify

A Multi-Center, Open-Label Study to Evaluate the Effect of ALTANA Inc's Cutivate (Fluticasone Propionate) Lotion 0.05% on the Hypothalmic Pituitary Adrenal (HPA) Axis in the Treatment of Atopic Dermatitis in a Pediatric Population

NCT00546000 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Fougera Pharmaceuticals Inc.
Phase	Phase 4
Status	COMPLETED
Enrolment	56
Start date	2007-07
Completion	2008-12

Conditions

Atopic Dermatitis

Interventions

Fluticasone propionate 0.05% lotion

Primary outcomes

Post Treatment Serum Cortisol Values Will be Compared. — Up to 29 days of treatment
The primary safety parameter was the response to the CST at the end of treatment/final visit. Blood samples were collected prior to injection of cosyntropin and post-injection. Post-CST stimulation cortisol level ≤ 18micrograms/dL was considered as evidence of adrenal suppression.

Countries

United States