Hidradenitis suppurativa
Conditions
Interventions
Trade Name: Metformina
Pharmaceutical Form: Tablet
INN or Proposed INN: METFORMIN
CAS Number: 657-24-9
Current Sponsor code: Metformin
Other descriptive name: Metformin
Concentration unit: mg milligra
Sponsors
Instituto de Investigación Sanitaria Fundación Jiménez Díaz
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of metformin in the treatment of patients with refractory hidradenitis suppurativa treatment;Secondary Objective: Evaluar la eficacia de metformina en el tratamiento de pacientes con Hidradenitis Supurativa refractaria a tratamiento.;Primary end point(s): The mean difference in the score Sartorius Scale property at the end of treatment (24 weeks) compared to baseline.;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 6, 12 and 24 weeks;Secondary end point(s): Descriptive analysis of baseline characteristics of the patients included ? average difference in score Sartorius Scale modified at 6 and 12 weeks of treatment compared to baseline. ? average difference in score Sartorius Scale at 6, 12 and 24 weeks of treatment compared to baseline. ?% of patients responding to treatment (defined as those who achieved =30% reduction in the score Sartorius Modified) at 6, 12 and 24 weeks. ?% of responders according to the change in the HS-PGA scale, defined as patients with a score of cleared, minimal or mild with at least two degrees of improvement over baseline score at week 24 of treatment. ?% of patients who respond to treatment according HiSCR (Hidradenitis Suppurativa Clinical Response) (reduction of at least 50% of nodules + abscesses, without increasing the number of abscesses without increasing the number of draining fistulas compared to baseline) to 6, 12 and 24 weeks. ? Mean improvement in the quality of life according to the DLQI at 6, 12 and 24 weeks of treatment ?% of patients achieving a decrease of 4 points DLQI at 6,12 and 24 weeks ? Mean improvement of pain according to EVA in the most painful injury chosen by the patient at 6, 12 and 24 weeks of treatment ?% means of compliance ?% of patients with adverse reactions to treatment (and description thereof) ?% of patients who have to abandon treatment by poor tolerability at the same ? Descriptive analysis of laboratory parameters at each visit and comparing relative to baseline. | — |
Countries
Spain
Contacts
Public ContactRaquel Muñoz
Instituto de Investigación Sanitaria Fundación Jiménez Díaz
Outcome results
None listed