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NCT01826461 · ClinicalTrials.gov registry record · Phase 2
An Evaluation of PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis
A Phase 2 study of Atopic Dermatitis, sponsored by PreCision Dermatology.
- Completed
- Registry status
- Phase 2
- Development phase
- 151
- Enrollment target
- 9
- Study locations
NCT01826461: Completed Phase 2 study of Atopic Dermatitis, sponsored by PreCision Dermatology.
NCT01826461 is a Phase 2 study of Atopic Dermatitis that has completed, run by PreCision Dermatology. The registered enrollment target is 151 participants, below the 608-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (75% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01826461, a Phase 2 study of Atopic Dermatitis, has completed, sponsored by PreCision Dermatology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 151 participants
- Enrollment target
- 9
- Study locations
Study Summary
This study will compare the safety and efficacy of three test article foams (PDI-192 0.1% Foam, PDI-192 0.15% Foam, and Vehicle Foam) such that a final commercial product may be selected for future development.
Primary Outcome
Success rate, based on IGA score. Success rate is defined as the percentage of subjects who achieve "Clear" (score = 0) or "Almost Clear" (score = 1) and at least a 2-grade improvement from Baseline on the IGA score at Day 29. IGA is a measure of overall severity of atopic dermatitis using a 5-point ordinal scale from 0 = clear to 4 = severe.
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG PDI-192
Study Locations (9)
Illinois
- Northwestern University - Chicago
- Sneeze, Wheeze & Itch Associates, LLC - Normal
Texas
- DermResearch, Inc. - Austin
- UT Houston Health Science Center - Houston
California
- UCSD - Rady Children's Hospital - San Diego
Minnesota
- Minnesota Clinical Study Center - Fridley
New Mexico
- Academic Dermatology Associates - Albuquerque
North Carolina
- Dermatology Consulting Services - High Point
Virginia
- Virginia Clinical Research, Inc. - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2013-03 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT01826461 record still lists
NCT01826461 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.
NCT01826461 lists 9 locations in 7 states (Illinois, Texas, California).
Frequently Asked Questions
What is clinical trial NCT01826461 about?
NCT01826461 is a clinical study titled "An Evaluation of PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis". This study will compare the safety and efficacy of three test article foams (PDI-192 0.1% Foam, PDI-192 0.15% Foam, and Vehicle Foam) such that a final commercial product may be selected for future development.
What is the current status of trial NCT01826461?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 151 participants. The study started on 2013-03. Estimated completion is 2013-12.
What conditions does trial NCT01826461 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT01826461?
The interventions under investigation include: Vehicle (DRUG), PDI-192 (DRUG).
Who is sponsoring clinical trial NCT01826461?
This trial is sponsored by PreCision Dermatology, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01826461 being conducted?
This trial has 9 study locations across California, Illinois, Minnesota, New Mexico, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01826461's enrollment target sits among peer trials
151 70th of 150 higher than 80 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.
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