Acne inversa Verneuil's disease
Conditions
Interventions
Group A will receive doxycycline 100mg once a day for the duration of 24 weeks.
Group B will receive a combination of doxycycline 100mg once a day plus
metformin for the duration of the study. Metfo
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
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.
Exclusion criteria
Exclusion criteria: • Pregnant and lactating women • Previously diagnosed diabetes mellitus and receiving active treatment • 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 • Contraindications for the use of either metformin (e.g. acute metabolic acidosis, or severe kidney failure with a creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the difference in International Hidradenitis Suppurativa Severity Score System (IHS4) between the groups at week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed