Status:
COMPLETED
A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis
Lead Sponsor:
Novan, Inc.
Collaborating Sponsors:
Novella Clinical
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of SB414 in subjects with mild to moderate AD.
Detailed Description
This is a phase 1b, multi-center, randomized, double-blind, vehicle-controlled study to be conducted in approximately 48 non-immunocompromised adult subjects with mild to moderate AD. Subjects will be...
Eligibility Criteria
Inclusion
- Male or female, 18 years of age and older, and in good general health;
- EASI score \>1 and ≤21, involving ≥5% body surface area (BSA).
- Two target lesions at least 5 cm2 with a TLSS ≥5. Target lesions can not be located on the groin, hands, elbows, feet, ankles, knees, face or scalp.
- Willing to not use any other products for AD during the study;
- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) prior to randomization and must agree to use an effective method of birth control during the study and for 30 days after their final study visit.
Exclusion
- Concurrent or recent use of topical or systemic medications without a sufficient washout period;
- Immunocompromised subjects including those who are known HIV positive or receiving current immunosuppressive treatment,
- Female subjects who are pregnant, nursing mothers, or planning to become pregnant during the study;
- Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.
Key Trial Info
Start Date :
November 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03431610
Start Date
November 13 2017
End Date
May 11 2018
Last Update
September 7 2018
Active Locations (9)
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1
Novella Site# 242
Coral Gables, Florida, United States, 33134
2
Novella Site# 264
Sweetwater, Florida, United States, 33172
3
Novella Site# 247
Boise, Idaho, United States, 83704
4
Novella Site# 251
Indianapolis, Indiana, United States, 46256