A randomized controlled trial investigating the metformin is the treatment for hidradenitis suppurativa. Metformin combined with doxycycline will be compared to the standard treatment of doxycycline monotherapy for HS severity and the effect on the pre-diabetic condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
Metformin in combination with doxycycline
Erasmus MC
Rotterdam, Netherlands
IHS4
International Hidradenitis Suppurativa Severity Score System (IHS4)
Time frame: 24 weeks
Insulin resistance
• Change in insulin resistance from baseline using the HOMA-IR (based on fasting glucose and insulin levels) and differences between the groups at week 12 and 24.
Time frame: 12 and 24 weeks
Lesion Count
• Change in lesion count from baseline and differences between the groups at 12 and 24 week. Difference in lesion count will be assessed between the groups at week 12 and 24.
Time frame: 12 and 24 weeks
NRS-Pain
Change in skin related pain from baseline, on a numerical rating scale, and differences between the groups at week 12 (V2) and 24 (V4)
Time frame: 12 and 24 weeks
Cost-effectiveness
• For cost-effectiveness the direct medical costs will be will be assessed using the iMTA Medical Consumption Questionnaire (iMCQ), The measurement will be at baseline, at 12 weeks and at 24 weeks. Productivity losses will be collected using the iMTA Productivity Cost Questionnaire (iPCQ) includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work. The friction cost method for valuing the production losses will be applied in accordance to the Dutch manual for costing studies. Hence, the productivity loss will be valued per worker by age and gender and, for long term absences, taking into account that productivity costs to society is confined to the period needed to replace a worker (the friction period). Cost effectiveness will be estimated using Dutch manual for costing studies in economic evaluations (publication of the Health Care Institute (ZIN).
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bio-markers
* The correlation between baseline calprotectin levels and disease severity for both groups. * The correlation between calprotectin levels and treatment response in each group at week 12 and 24.
Time frame: 24 weeks
Safety and Tolerability
• Incidence and severity of all adverse events (according to medDRA) will be analysed throughout the study, and renal function and lactate will be assessed at every visit.
Time frame: up to 24 weeks
Metabolic syndrome
Change in parameters of metabolic syndrome (waist circumference, blood pressure, HDL cholesterol, and triglycerides) from baseline and differences between the groups at week 12 and 24.
Time frame: 12 and 24 weeks
Pre-diabetic disorder
Change in HbA1c from baseline and differences between the groups at week 12 and week 24.
Time frame: 12 and 24 weeks
HiSCR
The percentage of HiSCR achievers (a ≥ 50% reduction in inflammatory lesion count (abscesses + inflammatory nodules), and no increase in abscesses or draining fistulas when compared with baseline) and the difference between the groups at week 12 and 24.
Time frame: 12 and 24 weeks
HS-PGA
The change in HS-PGA from baseline and the difference between the groups at week 12 and 24.
Time frame: 12 and 24 weeks
Flares
Change in self-reported frequency of flares from baseline and differences between the groups at week 12 and 24.
Time frame: 12 and 24 weeks
DLQI
Change in quality of life from baseline and differences between the groups, measured with the Dermatologic Life Quality Index and the EQ-5D, at week 12 and 24.
Time frame: 12 and 24 weeks
Treatment satisfaction
Difference in treatment satisfaction and recommendation on a 5- and 3-point Likert scale respectively at week 12 and 24 between the groups.
Time frame: up to 24 weeks