Pilot study to assess the efficacy of treatment with metformin in patients with Hidradenitis suppurativa refractory to standard treatment

Phase 1

• Conditions: Hidradenitis suppurativa; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2016-002714-45-ES
• Lead Sponsor: Instituto de Investigación Sanitaria Fundación Jiménez Díaz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-17
• Last Update Posted: 23 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Men or women over 14 years (in case of minors with parental consent or guardians)
2. Clinical diagnosis of hidradenitis suppurativa (defined by the presence of a) typical lesions: multiple deep inflammatory nodules, comedones, fistulas, sinus tracts, abscesses and / or fibrotic scars, b) in typical locations: armpits, English, inframammary regions, neck c) with chronic course with exacerbations and remissions) of moderate to severe (stage II-III Hurley)
3. That is refractory or recurrent oral antibiotics and / or topical and / or the patient does not tolerate, at the discretion of the investigator
4. In the case of women of childbearing age who are not planning pregnancy in the next 6 months and agree to use effective contraception during the treatment period (6 months) and until one month after the last dose of study medication.
5. are willing and able to participate in the study, comply with established procedures and to give his written consent after receiving appropriate information
Are the trial subjects under 18? yes
Number of subjects for this age range: 4
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnant or breastfeeding
2. Contraindications to the use of metformin hypersensitivity to the active substance or to any of the excipients, diabetic ketoacidosis, diabetic pre-coma, renal failure or renal dysfunction (creatinine clearance <60 mL / min), acute disease that poses a risk of impaired capable of causing chronic tissue hypoxia (cardiac or respiratory failure, myocardial infarction in the last month- recently, shock), liver failure, kidney function alcohol intoxication (dehydration, severe infection, shock), acute illness or acute (which has stated income), chronic alcoholism.
3. Patients pretreatment with metformin
4. medical or surgical history that the investigator's discretion not allow participation in the study.
5. Refusal to participate in the study and sign the consent.
6. are participating or have completed their participation in another clinical trial with drug or medical device within the last 30 days before the start of study treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified