Hidradenitis Suppurativa
Conditions
Interventions
It will be 30 patients. Each patient will have one axilla randomized to receive the treatment and the other contralateral will receive placebo.
Experimental: total dose of 100Units (U) onabotulinum
Drug
Sponsors
Universidade Federal de São Paulo- UNIFESP
Universidade Federal de São Paulo- UNIFESP
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 18 years old or more; Patients with bilateral axillary hidradenitis in the stage II-III according to Hurleys classification; At least one year with the disease;
Exclusion criteria
Exclusion criteria: Pregnant or lactating women; Hypersensitivity to botulinum toxin Neuromuscular diseases, such as myasthenia gravis or motor neuron disease Use of aminoglycoside antibiotics or other drugs that interfere with neuromuscular transmission. Patients receiving systemic treatment with immunobiological or retinoid or immunosuppressive drugs in the last 3 months. Patients receiving oral antibiotic, or infiltration of corticosteroid or surgical intervention for hidradenitis in the treated area within 4 weeks of initiation of the study. Patients who received botulinum toxin type A treatment in the treated area in the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with a good treatment response in the "Patient’s Global Assessment", at 12 weeks Description: Patients are asked to evaluate the extent of hidradenite activity compared to the initiation of treatment (D0). The answer includes: - Unsatisfied, worse than the baseline, would not recommend treatment. - Indifferent to treatment, equal to the baseline. -Satisfied, better than the baseline, would recommend the treatment and would do it again. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving "Hidradenitis Suppurativa Clinical Response" (HiSCR) at 2 weeks, 12 and 24 weeks. -Patients must have 3 or more inflammatory lesions in each axilla at baseline. Hidradenitis Suppurativa Clinical Response (HiSCR) is defined as reduction of inflammatory lesions> or = 50% (sum of abscesses and inflammatory nodules ), and no increase in abscesses and draining fistulas, compared to baseline (D0), prior to application. ;Visual pain and drainage score of 0-10 cm - comparison of the baseline with 2, 12 and 24 weeks. Patients will be asked to report their pain/drainage on a visual analogue scale with a 0-10cm vertical line, associated with the Wong-Baker Scale, with face design, to facilitate understanding, with 0 corresponding to absence of pain and 10 corresponding to severe pain / worse pain. Respondents will be defined as those achieving at least 30% reduction and 10 mm (1cm) of absolute reduction in pain score comparing D0 (therefore assessed among patients with> 10 mm at baseline). ;Proportion of participants with improvement in the photos by the Physician’s Global Assessment - evaluated at week 2, 12 and 24. Three independent physicians evaluated the extent of hidradenite activity by photos, compared to the baseline (D0).;Number of participants with adverse events with 2 weeks. ; Proportion of participants with a good treatment response in the "Patient’s Global Assessment", at 2 and 24 weeks Description: Patients are asked to evaluate the extent of hidradenite activity compared to the initiation of treatment (D0). The answer includes: - Unsatisfied, worse than the baseline, would not recommend treatment. - Indifferent to treatment, equal to the baseline. -Satisfied, better than the baseline, would recommend the treatment and would do it again. | — |
Countries
Brazil
Contacts
Public ContactLais de Mutti
Universidade Federal de São Paulo- UNIFESP
Outcome results
None listed