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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01137032
First received: June 2, 2010
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Psoriasis
Atopic Dermatitis
Drug: Pandel Cream 0.1%
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Fougera Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Post-injection serum cortisol level [ Time Frame: 22 Days ] [ Designated as safety issue: Yes ]
    The number of subjects with a post-injection serum cortisol level exceeding 18 ug/dL on Day 22.


Secondary Outcome Measures:
  • Pre-injection serum cortisol levels [ Time Frame: 22 Days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 19
Study Start Date: June 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test
Pandel Cream 0.1%
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

  Eligibility

Ages Eligible for Study:   3 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137032

Locations
United States, Nebraska
Christopher Huerter, MD
Omaha, Nebraska, United States, 68130
United States, South Carolina
Oswald Mikell, MD
Hilton Head Island, South Carolina, United States, 29926
United States, Tennessee
Michael Gold, MD
Nashville, Tennessee, United States, 37215
Sponsors and Collaborators
Fougera Pharmaceuticals Inc.
Investigators
Study Director: Angela C Kaplan Fougera Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01137032     History of Changes
Other Study ID Numbers: ALT 0153-01-1
Study First Received: June 2, 2010
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Fougera Pharmaceuticals Inc.:
Psoriasis
Atopic Dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Psoriasis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Diseases, Papulosquamous
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on July 22, 2014