Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT02595008|
Recruitment Status : Completed
First Posted : November 3, 2015
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dermatitis, Atopic||Drug: DSXS||Phase 2|
The objective of this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe atopic dermatitis.
The secondary objectives are to evaluate to evaluate adverse event (AE) profiles of DSXS administered to patients with moderate to severe atopic dermatitis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Safety Study to Assess the Potential for Adrenal Suppression and Pharmacokinetics Following Maximal Use Treatment With DSXS in Patients With Atopic Dermatitis.|
|Actual Study Start Date :||August 28, 2015|
|Actual Primary Completion Date :||February 22, 2017|
|Actual Study Completion Date :||August 25, 2017|
Experimental: DSXS topical product
treatment with DSXS twice daily for 28 days
Other Name: Active
- Number of Participants With HPA Axis Suppression [ Time Frame: 28 days. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595008
|United States, New York|
|Taro Pharmaceuticals USA Inc.|
|Hawthorne, New York, United States, 10532|
|Study Chair:||Novum Pharmaceutical Research Services||http://www.novumprs.com/contact|