No registrations found.
ID
Source
Brief title
Health condition
Hidradenitis Suppurativa
Sponsors and support
Intervention
Outcome measures
Primary outcome
International Hidradenitis Suppurativa Severity Score System (IHS4)
Secondary outcome
Insulin resistance and metabolic syndrome
Clinical efficacy
patient reported outcomes as NRS-pain, DLQI, Flares, treatment satisfaction and recommendation
Cost-effectiveness
Bio-markers
Safety and Tolerability
Background summary
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 objective
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.
Study design
12 and 24 weeks
Intervention
Metformin
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9050 |
| Other | METC Erasmus MC : EMCD20022 |