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Completed

NCT Number: NCT04649502

Metformin for the Treatment of Hidradenitis Suppurativa (HS)

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.

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Erasmus MC

Rotterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Pregnant and lactating women
  • Concomitant diabetes mellitus
  • Use of 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

Treatment and study plan

Metformin

Combination Product

Metformin in combination with doxycycline

Primary outcomes

  1. IHS4

    Time frame: 24 weeks

    International Hidradenitis Suppurativa Severity Score System (IHS4)

Secondary outcomes

  1. Insulin resistance

    Time frame: 12 and 24 weeks

    • 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.

  2. Lesion Count

    Time frame: 12 and 24 weeks

    • 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.

  3. NRS-Pain

    Time frame: 12 and 24 weeks

    Change in skin related pain from baseline, on a numerical rating scale, and differences between the groups at week 12 (V2) and 24 (V4)

  4. Cost-effectiveness

    Time frame: 24 weeks

    • 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).

  5. Bio-markers

    Time frame: 24 weeks

    • 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.

  6. Safety and Tolerability

    Time frame: up to 24 weeks

    • 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.

  7. Metabolic syndrome

    Time frame: 12 and 24 weeks

    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.

  8. Pre-diabetic disorder

    Time frame: 12 and 24 weeks

    Change in HbA1c from baseline and differences between the groups at week 12 and week 24.

  9. HiSCR

    Time frame: 12 and 24 weeks

    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.

  10. HS-PGA

    Time frame: 12 and 24 weeks

    The change in HS-PGA from baseline and the difference between the groups at week 12 and 24.

  11. Flares

    Time frame: 12 and 24 weeks

    Change in self-reported frequency of flares from baseline and differences between the groups at week 12 and 24.

  12. DLQI

    Time frame: 12 and 24 weeks

    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.

  13. Treatment satisfaction

    Time frame: up to 24 weeks

    Difference in treatment satisfaction and recommendation on a 5- and 3-point Likert scale respectively at week 12 and 24 between the groups.

Sponsors and collaborators

Lead sponsor

K.R. van Straalen

Other

Registry information

Official study title

Rediscovery of Metformin for the Chronic Disabling Auto-inflammatory Disease Hidradenitis Suppurativa

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2020
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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