Hidradenitis suppurativa
Conditions
Interventions
Trade Name: Metformin
Product Name: Metformin
Product Code: RVG 10500
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
Erasmus MC, Department of Dermatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age =18 years at baseline • A diagnosis of HS for at least 1 year prior to baseline • mild to moderately active disease defined by a HS Physician Global Assessment (HS-PGA) score of 2-3 and the Refined Hurley classification of mild to moderate at baseline • Indication for systemic therapy; i.e. uncontrolled disease under conventional topical therapy. • Able and willing to give written informed consent and to comply with the study requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 62 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnant and lactating women • Concomitant diabetes mellitus • Use of oral antibiotics within 14 days prior to baseline • Use of immunosuppressing/modulating therapies within 28 days prior to baseline • A known allergy to metformin or doxycycline or any of the ingredients metformin or doxycycline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the clinical efficacy of doxycycline and metformin compared with the standard treatment with doxycycline alone after 24 weeks of treatment.;Secondary Objective: - patient reported outcome measures: NRS-pain, flares, QoL (DLQI + EQ-5D-5L), treatment satisfaction and recommendation. - clinical effecacy: lesion count, HiSCR, HS-PGA. Insulin resistance and metabolic syndrome: HOMA-IR, Hba1c, (waist circumference, blood pressure, HDL cholesterol, and triglycerides). - Cost-effectiveness - Biomarker: calprotectin - Safety and tolerability: incidence and severity of all adverse events;Primary end point(s): The primary endpoint is the difference in International Hidradenitis Suppurativa Severity Score System (IHS4) between the groups;Timepoint(s) of evaluation of this end point: week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Patient reported outcome measures: • Change in skin related pain on a numerical rating scale from baseline and differences between the groups at week 12 and 24. • Change in self-reported frequency of flares from baseline and differences between the groups at week 12 and 24. • Change in quality of life measures with the DLQI and EQ-5D-5L from baseline and differences between the groups at week 12 and 24. • Treatment satisfaction and recommendation on a 5- and 3-point Likert scale respectively after 12 and 24 weeks Clinical efficacy • Change in lesion count from baseline and differences between the groups at week 12 and 24. • The percentage of HiSCR achievers after 12 and 24 weeks • The percentage of modified HiSCR achievers after 12 and 24 weeks • The percentage of patients with a reduction in HS-PGA from baseline and differences between the groups at week 12 and 24. after 12 and 24 weeks Insulin resistance and metabolic syndrome • Change in insulin resistance measured with the HOMA-IR from baseline and differences between the groups at week 12 and 24. • Change in HbA1c after from baseline and differences between the groups at week 12 and 24. • 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. Cost-effectiveness • Cost-effectiveness of both treatments Biomarker: • The correlation between baseline calprotectin levels and baseline disease severity. • The correlation between calprotectin levels and treatment response at week 12 and 24. Safety and tolerability: • Incidence and severity of all adverse events throughout the study;Timepoint(s) of evaluation of this end point: The endpoints for patient reported outcomes, clinical effecacy, insulin resistance and metabolic syndrome and biomarker will be 12 and 24 weeks. cost-effectivenes and safety and tolerability will be measured throughout the study and evaluat | — |
Countries
Netherlands
Contacts
Public ContactCoördinating investigator
Erasmus MC, Department of Dermatology
Outcome results
None listed