For Healthcare Professionals

A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis

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About the study

This is a Phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of SB414 in subjects with mild to moderate AD.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Male or female, 18 years of age and older, and in good general health;
  2. EASI score >1 and ≤21, involving ≥5% body surface area (BSA).
  3. 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.
  4. Willing to not use any other products for AD during the study;
  5. 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 CRITERIA

  1. Concurrent or recent use of topical or systemic medications without a sufficient washout period;
  2. Immunocompromised subjects including those who are known HIV positive or receiving current immunosuppressive treatment,
  3. Female subjects who are pregnant, nursing mothers, or planning to become pregnant during the study;
  4. Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 919-485-8080Email iconEmail Study Center

Study’s details


Contition

Atopic Dermatitis

Age

18+

Phase

Phase 1

Participants needed

48

Est. Completion Date

Nov 2018

Treatment type

Interventional


Sponsor

Novan, Inc.

ClinicalTrials.gov identifier

NCT03431610

Study number

NI-AD101

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