P3 Long Term Safety Study of Once Daily SB204 in Acne
- Conditions
- Acne Vulgaris
- Interventions
- Drug: SB204 4%
- Registration Number
- NCT02798120
- Lead Sponsor
- Novan, Inc.
- Brief Summary
This is a multi-center, open label long-term safety (LTS) study to be conducted in approximately 600 subjects with acne vulgaris.
- Detailed Description
A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 601
- Have completed 12 weeks of treatment in NI-AC301 or NI-AC302
- Terminated early from an SB204 Phase 3 pivotal study for any reason
- Have an on-going adverse event at Week 12 visit for NI-AC301 or NI-AC302 that warrants stopping study drug application
- Have used medications or vitamins during the 12 weeks immediately preceding this study which were reported to exacerbate acne.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SB204 4% SB204 4% All subjects received SB204 4% once daily (QD) in this open label study. Subjects assigned to SB204 4% QD in the parent study (NI-AC301/302) continued to receive SB204 for 40 more weeks. Subjects assigned to Vehicle Gel in the parent study (NI-AC301/302) received SB204 4% QD in this open label study.
- Primary Outcome Measures
Name Time Method Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303) Baseline This outcome measure shows the number of subjects with at least one ongoing adverse event from the pivotal studies (NI-AC301 and NI-AC302) at the time they rolled over into this study (NI-AC303). The final study visit (Week 12) for the pivotal studies served as the Baseline visit for this study. Subjects who were assigned to SB204 in the pivotal studies are denoted as SB204 Experienced and subjects who were assigned to Vehicle Gel on the pivotal studies are denoted as SB204 Naive.
Number of Subjects With Treatment Emergent Adverse Events Week 40/End of Treatment Number of subjects with adverse events that had an onset date on or after entry into study NI-AC303.
- Secondary Outcome Measures
Name Time Method Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) Baseline, Week 4, Week 12, Week 24, Week 36, Week 40 Analysis of cutaneous tolerability scores at each visit through end of treatment. Baseline is the Week 12 assessment from the previous study (NI-AC301 or NI-AC302). The Cutaneous Tolerability Assessment scale consisted of the investigator's assessment of erythema, scaling, and dryness at the time the assessment was made. Pruritus and burning/stinging were based on the subject's report for the previous 24 hours. Each component was graded on a scale of 0-3, with 0 being none (not present) and 3 being severe. Higher scores indicated a higher severity of reaction.
Inflammatory Lesion Counts by Study Visit Baseline through Week 40 Absolute count of inflammatory lesions at each visit (face only)--safety population
Non-Inflammatory Lesion Counts by Study Visit Baseline through Week 40 Absolute count of non-inflammatory lesions by study visit (face only)
Trial Locations
- Locations (69)
CIL #195
🇺🇸Santa Ana, California, United States
CIL #218
🇺🇸Mobile, Alabama, United States
CIL #210
🇺🇸Fresno, California, United States
CIL #146
🇺🇸Anaheim, California, United States
CIL #201
🇺🇸Berlin, New Jersey, United States
CIL #176
🇺🇸Saint Petersburg, Florida, United States
CIL #119
🇺🇸Santa Monica, California, United States
CIL #175
🇺🇸New Albany, Indiana, United States
CIL #213
🇺🇸La Mesa, California, United States
CIL #212
🇺🇸Homestead, Florida, United States
CIL #194
🇺🇸Richmond, Kentucky, United States
CIL #187
🇺🇸Saint Louis, Missouri, United States
CIL #103
🇺🇸Boca Raton, Florida, United States
CIL #143
🇺🇸Savannah, Georgia, United States
CIL #211
🇺🇸South Miami, 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 #208
🇺🇸Hialeah, Florida, United States
CIL #170
🇺🇸Miami Lakes, Florida, United States
CIL #227
🇺🇸Sanford, Florida, United States
CIL #148
🇺🇸Norfolk, Nebraska, United States
CIL #178
🇺🇸Philadelphia, Pennsylvania, United States
CIL #151
🇺🇸Plano, Texas, United States
CIL #215
🇺🇸Wichita, Kansas, United States
CIL #191
🇺🇸Overland Park, Kansas, United States
CIL #189
🇺🇸Phoenix, Arizona, United States
CIL #113
🇺🇸San Diego, California, United States
CIL #169
🇺🇸Cincinnati, Ohio, United States
CIL #224
🇺🇸San Antonio, Texas, United States
CIL #188
🇺🇸Houston, Texas, United States
CIL #139
🇺🇸Cerritos, California, United States
CIL #161
🇺🇸San Diego, California, United States
CIL #186
🇺🇸Fresno, California, United States
CIL #174
🇺🇸Huntington Beach, California, United States
CIL #199
🇺🇸Santa Rosa, California, United States
CIL #222
🇺🇸Lauderdale Lakes, Florida, United States
CIL #203
🇺🇸Ormond Beach, Florida, United States
CIL #153
🇺🇸Wellington, Florida, United States
CIL #116
🇺🇸Newnan, Georgia, United States
CIL #219
🇺🇸Monroe, Louisiana, United States
CIL #182
🇺🇸Las Vegas, Nevada, United States
CIL #108
🇺🇸Rochester, New York, United States
CIL #226
🇺🇸Cincinnati, Ohio, United States
CIL #237
🇺🇸Gresham, Oregon, United States
CIL #217
🇺🇸Chattanooga, Tennessee, United States
CIL #198
🇺🇸Arlington, Texas, United States
CIL #168
🇺🇸Plano, Texas, United States
CIL #106
🇺🇸Salt Lake City, Utah, United States
CIL #216
🇺🇸Chula Vista, California, United States
CIL #209
🇺🇸Oceanside, California, United States
CIL #154
🇺🇸Beaumont, Texas, United States
CIL #184
🇺🇸Bryan, Texas, United States
CIL #141
🇺🇸Montclair, New Jersey, United States
CIL #221
🇺🇸Salisbury, North Carolina, United States
CIL #137
🇺🇸Broomall, Pennsylvania, United States
CIL #105
🇺🇸Lynchburg, Virginia, United States
CIL #231
🇺🇸Norfolk, Virginia, United States
CIL #138
🇺🇸Birmingham, Alabama, United States
CIL #152
🇺🇸Tampa, Florida, United States
CIL #144
🇺🇸Tampa, Florida, United States
CIL #190
🇺🇸Sacramento, California, United States
CIL #172
🇺🇸Orlando, Florida, United States
CIL #229
🇺🇸Tampa, Florida, United States
CIL #117
🇺🇸Louisville, Kentucky, United States
CIL #140
🇺🇸Omaha, Nebraska, United States
CIL #156
🇺🇸Albuquerque, New Mexico, United States
CIL #200
🇺🇸Portland, Oregon, United States
CIL #160
🇺🇸Austin, Texas, United States