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NCT01137032 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Atopic Dermatitis and Psoriasis, sponsored by Fougera Pharmaceuticals.

Completed
Registry status
Phase 4
Development phase
19
Enrollment target
3
Study locations

NCT01137032: Completed Phase 4 study of Atopic Dermatitis and Psoriasis, sponsored by Fougera Pharmaceuticals.

NCT01137032 is a Phase 4 study of Atopic Dermatitis and Psoriasis that has completed, run by Fougera Pharmaceuticals. The registered enrollment target is 19 participants, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01137032, a Phase 4 study of Atopic Dermatitis and Psoriasis, has completed, sponsored by Fougera Pharmaceuticals.

COMPLETED
Registry status
Phase 4
Development phase
19 participants
Enrollment target
3
Study locations

Study 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.

Primary Outcome

The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22.

Interventions

  • DRUG Pandel Cream 0.1%

Study Locations (3)

Nebraska

  • Christopher Huerter, MD - Omaha

South Carolina

  • Oswald Mikell, MD - Hilton Head Island

Tennessee

  • Michael Gold, MD - Nashville

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2004-06
Est. Completion 2005-08
Phase Phase 4
Fougera Pharmaceuticals

7 total trials

What the finished NCT01137032 record still lists

NCT01137032 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (97% lower).

The record links to 2 conditions, with Atopic Dermatitis appearing as the primary indexed condition, and to 1 intervention - of which Pandel Cream 0.1% is the first listed.

NCT01137032 reports a single indexed study location in Nebraska, South Carolina, Tennessee.

Frequently Asked Questions

What is clinical trial NCT01137032 about?

NCT01137032 is a clinical study titled "Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population". 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.

What is the current status of trial NCT01137032?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 19 participants. The study started on 2004-06. Estimated completion is 2005-08.

What conditions does trial NCT01137032 study?

This clinical trial studies the following conditions: Atopic Dermatitis, Psoriasis.

What interventions are being tested in trial NCT01137032?

The interventions under investigation include: Pandel Cream 0.1% (DRUG).

Who is sponsoring clinical trial NCT01137032?

This trial is sponsored by Fougera Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01137032 being conducted?

This trial has 3 study locations across Nebraska, South Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Atopic Dermatitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01137032's enrollment target sits among peer trials

19 140th of 150 higher than 10 of 150 other Atopic Dermatitis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Atopic Dermatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01137032, the US trial registry maintained by the National Library of Medicine. NCT01137032 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.