PMID- 28095573
OWN - NLM
STAT- MEDLINE
DCOM- 20170523
LR  - 20170523
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 15
IP  - 12
DP  - 2016 Dec 1
TI  - Results of a Phase 2, Randomized,Vehicle-Controlled Study Evaluating the 
      Efficacy,Tolerability, and Safety of Daily or Twice Daily SB204 for the Treatment 
      of Acne Vulgaris.
PG  - 1496-15027
AB  - OBJECTIVE: This randomized, double-blind, placebo-controlled, Phase 2 study 
      compared efficacy, tolerability, and safety of SB204 once or twice daily to 
      vehicle in the treatment of acne vulgaris. METHODS: Eligible subjects were to be 
      between 12 and 40 years old, have facial acne vulgaris with 25 to 70 
      non-inflammatory lesions, 20 to 40 inflammatory lesions, no more than 2 nodules, 
      and a baseline Investigator's Global Assessment (IGA) score of moderate or 
      severe. The co-primary efficacy endpoints were the absolute change in 
      inflammatory and non-inflammatory lesion counts and IGA success rate (baseline to 
      week 12). Safety assessments included reported adverse events (AEs), physical 
      examinations, and laboratory testing. Tolerability was evaluated by the 
      investigators based on the occurrence and severity of erythema, scaling, dryness, 
      pruritus, and burning/stinging. RESULTS: A total of 213 subjects were randomized: 
      27 subjects to vehicle once daily; 29 subjects to vehicle twice daily; 53 
      subjects to SB204 2% twice daily; 52 subjects to SB204 4% once daily; and 52 
      subjects to SB204 4% twice daily. When compared to vehicle, treatment with all 3 
      SB204 regimens significantly reduced the absolute inflammatory lesion count and 
      SB204 4% once daily reduced the absolute non-inflammatory lesion count. Treatment 
      with SB204 4% once daily demonstrated a significant reduction in percent 
      inflammatory lesions by week 4. There were no significant differences in the IGA 
      success rates between groups at the end of treatment. All treatment regimens of 
      SB204 were found to be safe and well tolerated. CONCLUSIONS: When compared to 
      vehicle, SB204 2% and SB204 4% significantly decreased the absolute inflammatory 
      lesion count and SB204 4% once daily also significantly decreased the absolute 
      non-inflammatory lesion count in subjects with acne vulgaris treated for 12 
      weeks. Treatment with SB204 2% and 4% was found to be safe and well tolerated. J 
      Drugs Dermatol. 2016;15(12):1496-1502.
FAU - Eichenfield, Lawrence F
AU  - Eichenfield LF
FAU - Gold, Linda Stein
AU  - Gold LS
FAU - Nahm, Walter K
AU  - Nahm WK
FAU - Cook-Bolden, Fran E
AU  - Cook-Bolden FE
FAU - Pariser, David M
AU  - Pariser DM
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Dermatologic Agents)
RN  - 0 (Nitric Oxide Donors)
SB  - IM
MH  - Acne Vulgaris/*diagnosis/*drug therapy
MH  - Adolescent
MH  - Adult
MH  - Child
MH  - Dermatologic Agents/*administration & dosage
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Nitric Oxide Donors/*administration & dosage
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2017/01/18 06:00
MHDA- 2017/05/24 06:00
CRDT- 2017/01/18 06:00
PHST- 2017/01/18 06:00 [entrez]
PHST- 2017/01/18 06:00 [pubmed]
PHST- 2017/05/24 06:00 [medline]
AID - S1545961616P1496X [pii]
PST - ppublish
SO  - J Drugs Dermatol. 2016 Dec 1;15(12):1496-15027.