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

Completed · Phase 1 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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

Key facts

Study ID

NCT03431610

Run by

Novan, Inc.

People needed

48

Starts

2017-11-13

Expected to finish

2018-05-11

Last updated by the study team

2018-09-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novella Site# 242 — Coral Gables, Florida, United States
• Novella Site# 264 — Sweetwater, Florida, United States
• Novella Site# 247 — Boise, Idaho, United States
• Novella Site# 251 — Indianapolis, Indiana, United States
• Novella Site# 201 — Berlin, New Jersey, United States
• Novella Site# 250 — Portland, Oregon, United States
• Novella Site# 265 — Hazleton, Pennsylvania, United States
• Novells Site# 263 — Pflugerville, Texas, United States
• Novella Site# 114 — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.