Completed

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Evaluation of Twice Daily PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis in Subjects 3 Months to Less Than 18 Years of Age

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

PDI-192

+ PDI-192

+ Vehicle

Drug
Who is being recruted

Dermatitis+9

+ Hypersensitivity

+ Hypersensitivity, Immediate

From 3 Months to 17 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorPreCision Dermatology, Inc.
Last updated: May 29, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01826461
Principal SponsorPreCision Dermatology, Inc.
Last updated: May 29, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

151 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 3 Months to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DermatitisHypersensitivityHypersensitivity, ImmediateImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin Diseases, GeneticSkin and Connective Tissue DiseasesSkin Diseases, EczematousGenetic Diseases, InbornDermatitis, AtopicEczema

Criteria

2 inclusion criteria required to participate
Subject has used the same type of soap, moisturizers, lotions, creams, ointments, sunscreens or other skin products, and hair products (shampoo, etc.) for at least two weeks prior to study start and agrees to continue usage with the same products and with similar frequency for the entire study
Subject presents with a clinical diagnosis of stable mild to moderate atopic dermatitis
9 exclusion criteria prevent from participating
Subject desires excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) during the study
Subject has used Ultraviolet Light Therapy (PUVA, UVB, etc.) within 30 days prior to study start
Subject has used an investigational drug or investigational device treatment within 30 days prior to study start
Subject has used systemic (oral, IV, etc.) antibiotic therapy within seven days prior to study start
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
topical foam, 0.1% concentration, twice daily

Group II

Experimental
topical foam, 0.15% concentration, twice daily

Group III

Placebo
topical foam, 0% concentration, twice daily

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

UCSD - Rady Children's Hospital

San Diego, United StatesOpen UCSD - Rady Children's Hospital in Google Maps

Northwestern University

Chicago, United States

Sneeze, Wheeze & Itch Associates, LLC

Normal, United States

Minnesota Clinical Study Center

Fridley, United States
Completed9 Study Centers