NCT02932891

Brief Summary

An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment with DSXS in Patients with Atopic Dermatitis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2017

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 7, 2018

Completed
Last Updated

December 7, 2018

Status Verified

December 1, 2018

Enrollment Period

9 months

First QC Date

October 12, 2016

Results QC Date

November 12, 2018

Last Update Submit

December 5, 2018

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • The Number of Patients in the Study With HPA Axis Suppression

    Hypothalamic Pituitary Adrenal (HPA) Axis Response to a stimulator

    29 Days

Study Arms (1)

DSXS topical

EXPERIMENTAL

active treatment

Drug: DSXS topical

Interventions

DSXS topicalDRUG

topical treatment

Also known as: active
DSXS topical

Eligibility Criteria

Age6 Months - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parent/legal guardian has signed informed consent form, which meets all criteria of current FDA regulations.

You may not qualify if:

  • Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taro Pharmaceuticals USA Inc.

Hawthorne, New York, 10532, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Natalie Yantovskiy
Organization
Taro Pharmaceuticals U.S.A. Inc
Natalie.Yantovskiy@Taro.com
+1 914-345-9001

Study Officials

  • Novum Pharmaceutical Research Services

    http://www.novumprs.com/contact

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 13, 2016

Study Start

August 1, 2016

Primary Completion

April 14, 2017

Study Completion

December 12, 2017

Last Updated

December 7, 2018

Results First Posted

December 7, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)