15% TOPICAL RESORCINOL FOR HURLEY I-II HIDRADENITIS SUPPURATIVA.
|ClinicalTrials.gov Identifier: NCT04099212|
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : February 12, 2020
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||OBSERVATIONAL CASE-ONLY PROSPECTIVE STUDY OF EFFECTIVENESS AND SAFETY OF 15% TOPICAL RESORCINOL FOR ADULTS WITH HURLEY I-II HIDRADENITIS SUPPURATIVA.|
|Actual Study Start Date :||May 15, 2019|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||August 30, 2020|
Patients with HS I-II in monotherapy treatment of topical resorcinol 15%
- Evaluate the change in the disease severity [ Time Frame: Up to 16 weeks ]Score change in the Hidradenitis Sartorius modified score
- Usage profile [ Time Frame: Initial ]Descriptive measurement of demographic and clinical variables (central tendency, dispersion and distribution of tendencies) prior to the start of treatment.
- Evaluate the security of the treatment [ Time Frame: Up to 16 weeks ]Number and description of adverse effects, analysing the percentage and frequency of withdrawal and treatment suspension due to side effects.
- Evaluate the changes in the patient´s quailty of life due to the treatment [ Time Frame: Up to 16 weeks ]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.
- Evaluate the changes in the patient´s quailty of life due to the treatment 2 [ Time Frame: Up to 16 weeks ]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.
- Total and partial ultrasound responders frequency of distribution. [ Time Frame: Up to 16 weeks ]
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.
- Evaluate the frequency of responders [ Time Frame: Up to 16 weeks ]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.
- Evaluate the change in the disease severity. [ Time Frame: Up to 16 weeks ]Score change in the Physician Global Assesment scale for Supurative Hidradenitis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099212
|Contact: Jaime Cordero Ramosfirstname.lastname@example.org|
|Contact: Carlos García Pérez||600 162 email@example.com|
|Hospital Universitario Virgen Macarena||Recruiting|
|Sevilla, Spain, 41009|
|Contact: David Moreno Ramírez 955 00 80 00|
|Principal Investigator:||David Moreno Ramírez||Hospital Universitario Virgen Macarena|