Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis
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|ClinicalTrials.gov Identifier: NCT04091087|
Recruitment Status : Active, not recruiting
First Posted : September 16, 2019
Last Update Posted : November 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stasis Dermatitis||Drug: crisaborole ointment Other: vehicle ointment||Phase 2|
Study C3291038 is a Phase 2a, randomized, double-blind, vehicle-controlled, parallel-group, proof of concept study to evaluate the efficacy, safety, and local tolerability of 6 weeks of treatment with crisaborole in adult participants with SD without active skin ulceration. Approximately 92 eligible participants will be randomized into the double blind treatment period in a 1:1 ratio to receive crisaborole ointment, 2% or vehicle twice daily for 6 weeks.
The study will recruit male and female participants aged ≥ 45 years with a clinical diagnosis of SD.
The total duration of participation in the study will be up to 14 weeks, including up to 4 weeks for screening, a 6 week double blind treatment period, and a follow-up period of 4 weeks after treatment completion.
Study enrollment and management will be de centralized, where participants do not visit an investigator or a clinic for clinical assessment. The participants will participate in the study at home. The sponsor (or designee) will provide home visits by qualified home visit practitioners (HVP), remote contact by telemedicine (or telephone), and clinical database electronic case report forms (eCRFs), eDiary, and other electronic data entries from 3rd party vendors for study data collection.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Local Tolerability of Crisaborole Ointment, 2%, in Adult Participants With Stasis Dermatitis Without Active Skin Ulceration|
|Actual Study Start Date :||June 26, 2020|
|Estimated Primary Completion Date :||August 23, 2021|
|Estimated Study Completion Date :||August 23, 2021|
Experimental: crisaborole ointment
Drug: crisaborole ointment
Other Name: Eucrisa
Sham Comparator: vehicle ointment
Other: vehicle ointment
- Percent change from baseline in Total Sign Score [ Time Frame: 6 weeks ]Percent change from baseline in Total Sign Score at Week 6
- Investigator's Static Global Assessment [ Time Frame: Weeks 1-6 ]Achievement of an Investigator's Static Global Assessment score of Clear (0) or Almost Clear (1) with at least a 2 grade improvement from baseline at all time points
- Investigators Static Global Assessment [ Time Frame: Weeks 1-6 ]Achievement of an Investigator's Static Global Assessment score of Clear (0) or Almost Clear (1) at all time points
- Total Sign Score [ Time Frame: Weeks 1-6 ]Percent change from baseline in TSS at all time points (Central Readers digital images assessment)
- Lesional percent body surface area [ Time Frame: Weeks 1-6 ]Percent change from baseline in lesional % Body Surface Area
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): NCT04091087
|United States, California|
|Hawthorne Effect, Inc|
|Lafayette, California, United States, 94549|
|Verily Life Sciences LLC|
|South San Francisco, California, United States, 94080|
|United States, Kentucky|
|Onco360 Oncology Pharmacy|
|Louisville, Kentucky, United States, 40223|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|