Metformin for the Treatment of Hidradenitis Suppurativa (HS)

K.R. van Straalen

Status and phase: Completed; Phase 3

Conditions: Hidradenitis Suppurativa

Treatments: Combination Product: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT04649502

EMCD20022

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups, including a placebo group

Metformin combined with doxycycline

Experimental group

Treatment:

Combination Product: Metformin

Doxycyline combined with placebo

Placebo Comparator group

Treatment:

Combination Product: Metformin