Metformin for the Treatment of Hidradenitis Suppurativa (HS)

Hidradenitis Suppurativa Clinical Trial

Official title:

Rediscovery of Metformin for the Chronic Disabling Auto-inflammatory Disease Hidradenitis Suppurativa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04649502
• Other study ID #: EMCD20022
• Status: Completed
• Phase: Phase 3
• Start date: January 25, 2021
• Est. completion date: August 23, 2023

Study information

• Verified date: October 2023
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 23, 2023
• Est. primary completion date: January 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Combination Product:
• Metformin
Metformin in combination with doxycycline

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
K.R. van Straalen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IHS4	International Hidradenitis Suppurativa Severity Score System (IHS4)	24 weeks
Secondary	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.	12 and 24 weeks
Secondary	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.	12 and 24 weeks
Secondary	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)	12 and 24 weeks
Secondary	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).	24 weeks
Secondary	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.	24 weeks
Secondary	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.	up to 24 weeks
Secondary	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.	12 and 24 weeks
Secondary	Pre-diabetic disorder	Change in HbA1c from baseline and differences between the groups at week 12 and week 24.	12 and 24 weeks
Secondary	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.	12 and 24 weeks
Secondary	HS-PGA	The change in HS-PGA from baseline and the difference between the groups at week 12 and 24.	12 and 24 weeks
Secondary	Flares	Change in self-reported frequency of flares from baseline and differences between the groups at week 12 and 24.	12 and 24 weeks
Secondary	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.	12 and 24 weeks
Secondary	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.	up to 24 weeks