Hidradenitis SuppurativaPhase 3NCT04649502
Metformin for the Treatment of Hidradenitis Suppurativa (HS)
A Phase 3 study testing Metformin in people with Hidradenitis Suppurativa, run by K.R. van Straalen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Jan 2021to 23 Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Rediscovery of Metformin for the Chronic Disabling Auto-inflammatory Disease Hidradenitis Suppurativa
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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Metformin
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminCombination product
Metformin in combination with doxycycline
| Study group | Role | What they receive |
|---|---|---|
| Metformin combined with doxycycline | Experimental | Not described Receives: Combination Product: Metformin |
| Doxycyline combined with placebo | Placebo comparator | Not described Receives: Combination Product: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
IHS4
International Hidradenitis Suppurativa Severity Score System (IHS4)
Measured: 24 weeks
Secondary outcomes (13)
Insulin resistance
- Change in insulin resistance from baseline using the HOMA-IR (based on fasting glucose and insulin levels) and differences between the groups at week 12 and 24.
Measured: 12 and 24 weeks
Lesion Count
- Change in lesion count from baseline and differences between the groups at 12 and 24 week. Difference in lesion count will be assessed between the groups at week 12 and 24.
Measured: 12 and 24 weeks
NRS-Pain
Change in skin related pain from baseline, on a numerical rating scale, and differences between the groups at week 12 (V2) and 24 (V4)
Measured: 12 and 24 weeks
Cost-effectiveness
- For cost-effectiveness the direct medical costs will be will be assessed using the iMTA Medical Consumption Questionnaire (iMCQ), The measurement will be at baseline, at 12 weeks and at 24 weeks. Productivity losses will be collected using the iMTA Productivity Cost Questionnaire (iPCQ) includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work. The friction cost method for valuing the production losses will be applied in accordance to the Dutch manual for costing studies. Hence, the productivity loss will be valued per worker by age and gender and, for long term absences, taking into account that productivity costs to society is confined to the period needed to replace a worker (the friction period). Cost effectiveness will be estimated using Dutch manual for costing studies in economic evaluations (publication of the Health Care Institute (ZIN).
Measured: 24 weeks
Bio-markers
- The correlation between baseline calprotectin levels and disease severity for both groups.
- The correlation between calprotectin levels and treatment response in each group at week 12 and 24.
Measured: 24 weeks
Safety and Tolerability
- Incidence and severity of all adverse events (according to medDRA) will be analysed throughout the study, and renal function and lactate will be assessed at every visit.
Measured: up to 24 weeks
Metabolic syndrome
Change in parameters of metabolic syndrome (waist circumference, blood pressure, HDL cholesterol, and triglycerides) from baseline and differences between the groups at week 12 and 24.
Measured: 12 and 24 weeks
Pre-diabetic disorder
Change in HbA1c from baseline and differences between the groups at week 12 and week 24.
Measured: 12 and 24 weeks
HiSCR
The percentage of HiSCR achievers (a ≥ 50% reduction in inflammatory lesion count (abscesses + inflammatory nodules), and no increase in abscesses or draining fistulas when compared with baseline) and the difference between the groups at week 12 and 24.
Measured: 12 and 24 weeks
HS-PGA
The change in HS-PGA from baseline and the difference between the groups at week 12 and 24.
Measured: 12 and 24 weeks
Flares
Change in self-reported frequency of flares from baseline and differences between the groups at week 12 and 24.
Measured: 12 and 24 weeks
DLQI
Change in quality of life from baseline and differences between the groups, measured with the Dermatologic Life Quality Index and the EQ-5D, at week 12 and 24.
Measured: 12 and 24 weeks
Treatment satisfaction
Difference in treatment satisfaction and recommendation on a 5- and 3-point Likert scale respectively at week 12 and 24 between the groups.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start25 Jan 2021
- Primary completion29 Jan 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- K.R. van Straalen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, K.R. van Straalen, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649502
- Sponsor's protocol ID
- EMCD20022
- Status last verified
- Oct 2023
- First submitted
- 16 Nov 2020
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rediscovery of Metformin for the Chronic Disabling Auto-inflammatory Disease Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT04649502
- Acronym / sponsor ID
- EMCD20022
- Conditions
- Hidradenitis Suppurativa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- K.R. van StraalenUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 29 Jan 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Metformin combined with doxycycline | Experimental | Combination Product: Metformin |
| Doxycyline combined with placebo | Placebo comparator | Combination Product: Metformin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin in combination with doxycycline | Combination product | Doxycyline combined with placebo, Metformin combined with doxycycline |
Primary outcome
IHS4
Time frame: 24 weeks
International Hidradenitis Suppurativa Severity Score System (IHS4)
13 secondary outcomes
Insulin resistance
Time frame: 12 and 24 weeks
Lesion Count
Time frame: 12 and 24 weeks
NRS-Pain
Time frame: 12 and 24 weeks
Cost-effectiveness
Time frame: 24 weeks
Bio-markers
Time frame: 24 weeks
Safety and Tolerability
Time frame: up to 24 weeks
Metabolic syndrome
Time frame: 12 and 24 weeks
Pre-diabetic disorder
Time frame: 12 and 24 weeks
HiSCR
Time frame: 12 and 24 weeks
HS-PGA
Time frame: 12 and 24 weeks
Flares
Time frame: 12 and 24 weeks
DLQI
Time frame: 12 and 24 weeks
Treatment satisfaction
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Hidradenitis Suppurativa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin in people with Hidradenitis Suppurativa, run by K.R. van Straalen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IHS4 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.