NCT02595008

Brief Summary

this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe atopic dermatitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2015

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 28, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2017

Completed
1.3 years 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

1.5 years

First QC Date

November 1, 2015

Results QC Date

November 12, 2018

Last Update Submit

December 5, 2018

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With HPA Axis Suppression

    Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml.

    28 days.

Study Arms (1)

DSXS topical product

EXPERIMENTAL

treatment with DSXS twice daily for 28 days

Drug: DSXS

Interventions

DSXSDRUG

Active treatment

Also known as: Active
DSXS topical product

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a definite clinical diagnosis of stable atopic dermatitis

You may not qualify if:

  • Patient is under the age of 2

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

November 1, 2015

First Posted

November 3, 2015

Study Start

August 28, 2015

Primary Completion

February 22, 2017

Study Completion

August 25, 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)