This pilot study will explore if continuation of treatment of treatment with Aczone 5% gel following combination treatment with with doxycycline and Aczone 5% gel can maintain therapeutic response.
This is a two-center, open-label pilot study. The study is apprised of 7 study visits: Baseline and Weeks 4, 8, 12, 16, 20 and 24. All subjects will receive Aczone 5% gel BID and doxycycline 100mg by mouth once daily at Baseline. Those subjects achieving treatment response (i.e., IGA of 0, 1 or 2) at Week 12 will continue treatment with Aczone 5% gel BID at Week 12. Subjects not achieving treatment response will discontinue study participation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Doxycycline 100mg by mouth once daily
Aczone 5% gel twice daily
DermResearch, PLLC
Louisville, Kentucky, United States
Percentage of Participants Who Remained Responders at Week 24
At week 12 responder had an IGA \<3 on a 6-point scale ranging from 0 (clear) to 5 (very severe) and at Week 24 this response was maintained
Time frame: Assessed every 4 weeks, reported at Week 24
Inflammatory and Non-inflammatory Lesion Counts
Time frame: Every 4 weeks
Percentage of Participants Who Are Responders at Week 16 and 20
Responders is the percentage of participants who have an IGA \<3 at Week 16 and 20
Time frame: Assessed every 4 weeks, reported at weeks 16 and 20
Nodule Counts
number of nodules counted
Time frame: every four weeks
Erythema
the erythema severity scale ranges from 0 to 4 with 0 being no erythema and 4 being most extreme erythema
Time frame: every 4 weeks
Dryness
the dryness severity scale ranges from 0 to 4 with 0 being no dryness and 4 being most extreme dryness
Time frame: every 4 weeks
Peeling
the peeling severity scale ranges from 0 to 4 with 0 being no peeling and 4 being most extreme peeling
Time frame: every four weeks
Oiliness
the oiliness severity scale ranges from 0 to 10 with 0 being no oiliness and 10 being most extreme oiliness
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: every 4 weeks
Pruritis
the pruritis severity scale ranges from 0 to 5 with 0 being no pruritis and 5 being the most extreme pruritis
Time frame: every 4 weeks
Burning
the burning severity scale ranges from 0 to 10 with 0 being no burning and 10 being most extreme burning
Time frame: every 4 weeks