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

Psoriasis Clinical Trial

Official title:

An Open -Label Study to Evaluate the Effect of Pandel Cream 0.1% on the Hypothalamic Pituitary Adrenal Axis in the Pediatric and Adult Population

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01137032
• Other study ID #: ALT 0153-01-1
• Status: Suspended
• Phase: Phase 4
• First received: June 2, 2010
• Last updated: June 25, 2014
• Start date: June 2004
• Est. completion date: December 2014

Study information

• Verified date: June 2014
• Source: Fougera Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 19
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Psoriasis

Intervention

Drug:
• Pandel Cream 0.1%
A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days

Locations

Country	Name	City	State
United States	Oswald Mikell, MD	Hilton Head Island	South Carolina
United States	Michael Gold, MD	Nashville	Tennessee
United States	Christopher Huerter, MD	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Fougera Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-injection serum cortisol level	The number of subjects with a post-injection serum cortisol level exceeding 18 ug/dL on Day 22.	22 Days	Yes
Secondary	Pre-injection serum cortisol levels	The number of subjects with pre-injection serum cortisol levels exceeding 5 ug/dL Day 22 and the number of subjects with an increment between basal and 30 minutes Day 22 of at least 7 ug/dL.	22 Days	Yes