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

NCT ID: NCT01137032

Last Updated: 2016-05-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis Atopic Dermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pandel Cream 0.1%

Pandel Cream 0.1%

Group Type EXPERIMENTAL

Pandel Cream 0.1%

Intervention Type DRUG

A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fougera Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela C Kaplan

Role: STUDY_DIRECTOR

Fougera Pharmaceuticals Inc.

Locations

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Christopher Huerter, MD

Omaha, Nebraska, United States

Site Status

Oswald Mikell, MD

Hilton Head Island, South Carolina, United States

Site Status

Michael Gold, MD

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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ALT 0153-01-1

Identifier Type: -

Identifier Source: org_study_id

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