A Study Examining the Medication Apremilast as Treatment for Chronic Itch
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|ClinicalTrials.gov Identifier: NCT03239106|
Recruitment Status : Completed
First Posted : August 3, 2017
Results First Posted : April 20, 2020
Last Update Posted : October 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Itch||Drug: Apremilast||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||open label|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Study of Apremilast in Chronic Idiopathic Pruritus|
|Actual Study Start Date :||December 1, 2017|
|Actual Primary Completion Date :||October 31, 2018|
|Actual Study Completion Date :||September 19, 2019|
Experimental: open label
All participants will receive Apremilast 30 mg BID.
Apremilast 30 mg BID daily
Other Name: Otezla
- Absolute NRS Itch Score at Week 16 (End of Treatment) [ Time Frame: Week 16 ]
Participants will complete a Numeric Rating Scale for itch (0 representing "no itching" through 10 representing "worst itch imaginable") will be recalled from prior 24 hours and the prior week.
0 is the best score (minimum) and 10 is the worst score (maximum) in terms of clinical outcome. This is an ordinal scale that runs from 0 to 10.
- Absolute DLQI at Week 16 [ Time Frame: Week 16 ]
Participants will complete a 10 question Dermatology Quality of Life survey at baseline through Week 16
The DLQI is a numerical scale that scores multiple parameters of skin symptoms on a scale from 0 to 30. 0-1 = no effect at all on a patient's life (most favorable clinical outcome and minimum score), 1-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20 = very large effect on patient's life, 21-30 = extremely large effect on patient's life (worse clinical outcome and maximum score).
- NRS at Screening, Baseline and Weeks 2,4,8,12,16,and 18 [ Time Frame: Screening through Week 18 (follow up visit) ]Participants' itch will be measured utilizing the Numeric Rating Scale for itch
- DLQI at Screening, Baseline, and Weeks 2,4,8,12,16 and 18 [ Time Frame: Screening through Week 18 (follow up visit) ]Participants will complete a 10 question Dermatology Life Quality Index questionnaire at Screening, Baseline, and Weeks 2,4,8,12,16,18.
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): NCT03239106
|United States, Missouri|
|Washington University Division of Dermatology|
|Saint Louis, Missouri, United States, 63108|
|Principal Investigator:||Brian S. Kim, MD||Washington University School of Medicine|