NCT04649502

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2021

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2023

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

November 16, 2020

Last Update Submit

October 9, 2023

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

  • IHS4

    International Hidradenitis Suppurativa Severity Score System (IHS4)

    24 weeks

Secondary Outcomes (13)

  • Insulin resistance

    12 and 24 weeks

  • Lesion Count

    12 and 24 weeks

  • NRS-Pain

    12 and 24 weeks

  • Cost-effectiveness

    24 weeks

  • Bio-markers

    24 weeks

  • +8 more secondary outcomes

Study Arms (2)

Metformin combined with doxycycline

EXPERIMENTAL
Combination Product: Metformin

Doxycyline combined with placebo

PLACEBO COMPARATOR
Combination Product: Metformin

Interventions

MetforminCOMBINATION_PRODUCT

Metformin in combination with doxycycline

Doxycyline combined with placeboMetformin combined with doxycycline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Metformin

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD.

Study Record Dates

First Submitted

November 16, 2020

First Posted

December 2, 2020

Study Start

January 25, 2021

Primary Completion

January 29, 2023

Study Completion

August 23, 2023

Last Updated

October 11, 2023

Record last verified: 2023-10

Locations

NL(1)