P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne

Completed · Phase 3 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.

Key facts

Study ID

NCT02667444

Run by

Novan, Inc.

People needed

1330

Starts

2016-02-19

Expected to finish

2016-12-09

Last updated by the study team

2023-07-24

Who can join

Age: 9 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Moderate to severe acne
• Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones) on the face
• Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)

You may not qualify if…

• Women of child-bearing potential who are pregnant, nursing, considering becoming pregnant
• Any dermatologic condition that could interfere with clinical evaluations including severe, recalcitrant cystic acne

Where it is running

• CIL #218 — Mobile, Alabama, United States
• CIL #189 — Phoenix, Arizona, United States
• CIL #139 — Cerritos, California, United States
• CIL #216 — Chula Vista, California, United States
• CIL #181 — Encino, California, United States
• CIL #174 — Huntington Beach, California, United States
• CIL #213 — La Mesa, California, United States
• CIL #190 — Sacramento, California, United States
• CIL #111 — San Diego, California, United States
• CIL #195 — Santa Ana, California, United States
• CIL #119 — Santa Monica, California, United States
• CIL #158 — Bradenton, Florida, United States
• CIL #208 — Hialeah, Florida, United States
• CIL #142 — Miami, Florida, United States
• CIL #170 — Miami Lakes, Florida, United States
• CIL #204 — Miami Springs, Florida, United States
• CIL #185 — Ormond Beach, Florida, United States
• CIL #110 — Pinellas Park, Florida, United States
• CIL #227 — Sanford, Florida, United States
• CIL #176 — St. Petersburg, Florida, United States
• CIL #152 — Tampa, Florida, United States
• CIL #144 — Tampa, Florida, United States
• CIL #116 — Newnan, Georgia, United States
• CIL #143 — Savannah, Georgia, United States
• CIL #214 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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