Metformin combined with doxycycline will result in a better improvement in HS severity and the pre-diabetic condition of the patients compared to doxycycline monotherapy.
ID
Bron
Verkorte titel
Aandoening
Hidradenitis Suppurativa
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
International Hidradenitis Suppurativa Severity Score System (IHS4)
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Metformin combined with doxycycline will result in a better improvement in HS severity and the pre-diabetic condition of the patients compared to doxycycline monotherapy.
Onderzoeksopzet
12 and 24 weeks
Onderzoeksproduct en/of interventie
Metformin
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9050 |
| Ander register | METC Erasmus MC : EMCD20022 |