HYDRADENITIS Clinical Trial
Official title:
OBSERVATIONAL CASE-ONLY PROSPECTIVE STUDY OF EFFECTIVENESS AND SAFETY OF 15% TOPICAL RESORCINOL FOR ADULTS WITH HURLEY I-II HIDRADENITIS SUPPURATIVA.
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | August 30, 2020 |
| Est. primary completion date | April 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Age > 18 years. - Diagnosed with HS Hurley I-II degree. - Patients that have at least 1 or more swollen up nodules and/or abscess. - Availability of affected region control ultrasound prior to resorcine treatment beginning. Exclusion Criteria: - Age < 18 years. - Number of draining fistula above 20. - Patients in active treatment with immunomodulators. - Patients in active treatment with antibiotics. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitario Virgen Macarena | Sevilla |
| Lead Sponsor | Collaborator |
|---|---|
| Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate the change in the disease severity | Score change in the Hidradenitis Sartorius modified score | Up to 16 weeks | |
| Secondary | Usage profile | Descriptive measurement of demographic and clinical variables (central tendency, dispersion and distribution of tendencies) prior to the start of treatment. | Initial | |
| Secondary | Evaluate the security of the treatment | Number and description of adverse effects, analysing the percentage and frequency of withdrawal and treatment suspension due to side effects. | Up to 16 weeks | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Evaluate the change in the disease severity. | Score change in the Physician Global Assesment scale for Supurative Hidradenitis | Up to 16 weeks |