Metformin for the Treatment of Hidradenitis Suppurativa (HS)

NCT ID: NCT04649502

Last Updated: 2023-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-25

Study Completion Date

2023-08-23

Brief Summary

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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.

Detailed Description

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Conditions

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Hidradenitis Suppurativa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double blind

Study Groups

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Metformin combined with doxycycline

Group Type EXPERIMENTAL

Metformin

Intervention Type COMBINATION_PRODUCT

Metformin in combination with doxycycline

Doxycyline combined with placebo

Group Type PLACEBO_COMPARATOR

Metformin

Intervention Type COMBINATION_PRODUCT

Metformin in combination with doxycycline

Interventions

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Metformin

Metformin in combination with doxycycline

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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K.R. van Straalen

OTHER

Sponsor Role lead

Responsible Party

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K.R. van Straalen

MD.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Erasmus MC

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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EMCD20022

Identifier Type: -

Identifier Source: org_study_id

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