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Prospective, observational cross-sectional study to evaluate the response of patients with HS I-II to monotherapy treatment of topical resorcin 15%, taking into account its safety, impact on quality of life and subclinical evolution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Patients with HS I-II in monotherapy treatment of topical resorcinol 15% |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the change in the disease severity | Score change in the Hidradenitis Sartorius modified score | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Usage profile | Descriptive measurement of demographic and clinical variables (central tendency, dispersion and distribution of tendencies) prior to the start of treatment. | Initial |
| Evaluate the security of the treatment |
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Inclusion Criteria:
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Patients that suffer from Hs Hurley I-II from the Andalusian Public Health System that are been follow up by the Dermatology Unity of Clinical Management of the HUVM.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaime Cordero Ramos | Contact | 600162807 | jaime.cordero.sspa@juntadeandalucia.es | |
| Carlos García Pérez | Contact | 600 162 458 | administracion.eecc.hvm.sspa@juntadeandalucia.es |
| Name | Affiliation | Role |
|---|---|---|
| David Moreno Ramírez | Hospital Universitario Virgen Macarena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen Macarena | Recruiting | Seville | 41009 | Spain |
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| ID | Term |
|---|---|
| D016575 | Hidradenitis |
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017192 | Skin Diseases, Bacterial |
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Number and description of adverse effects, analysing the percentage and frequency of withdrawal and treatment suspension due to side effects.
| Up to 16 weeks |
| Evaluate the changes in the patient´s quailty of life due to the treatment | Quantified by the average absolute change of the dermatology life quality index (DLQI) score, a questionnaire that measures the effect that the skin disease has on the quality of life of an affected person. | Up to 16 weeks |
| Evaluate the changes in the patient´s quailty of life due to the treatment 2 | Quantified by the average absolute changein the visual analog scale of pain, odor and suppuration, a scale used to measure the intensity or frequency of the symptoms related to the pain, odor and suppuration of the disease. | Up to 16 weeks |
| Total and partial ultrasound responders frequency of distribution. | Change in number of fistulas, pseudocysts and abscess as well as change in doppler activity. Defining total ultrasound responders as the ones that have a smaller number of pseudocysts, liquid collections, fistulas, smaller size and thickness of the main injury and less doppler activity than the registered in the baseline ultrasound and partial ultrasound responders as the ones that have less activity than in the baseline ultrasound in at least one of the previous variables without increase in any of the others. | Up to 16 weeks |
| Evaluate the frequency of responders | Defining responder as the combination of the decrease in the abscess/nodule count by at least 50% (minimum of one), without increase in the number of draining fistulas and the number of abscesses. | Up to 16 weeks |
| Evaluate the change in the disease severity. | Score change in the Physician Global Assesment scale for Supurative Hidradenitis | Up to 16 weeks |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |