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15% TOPICAL RESORCINOL FOR HURLEY I-II HIDRADENITIS SUPPURATIVA.

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ClinicalTrials.gov Identifier: NCT04099212
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary:
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.

Condition or disease
HYDRADENITIS

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 : November 30, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Resorcinol

Group/Cohort
Cases
Patients with HS I-II in monotherapy treatment of topical resorcinol 15%



Primary Outcome Measures :
  1. Evaluate the change in the disease severity [ Time Frame: Up to 16 weeks ]
    Score change in the Hidradenitis Sartorius modified score


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


  6. 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.

  7. Evaluate the change in the disease severity. [ Time Frame: Up to 16 weeks ]
    Score change in the Physician Global Assesment scale for Supurative Hidradenitis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099212


Contacts
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Contact: Jaime Cordero Ramos 600162807 jaime.cordero.sspa@juntadeandalucia.es
Contact: Carlos García Pérez 600 162 458 administracion.eecc.hvm.sspa@juntadeandalucia.es

Locations
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Spain
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41009
Contact: David Moreno Ramírez    955 00 80 00      
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
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Principal Investigator: David Moreno Ramírez Hospital Universitario Virgen Macarena

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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT04099212     History of Changes
Other Study ID Numbers: FIS-RES-2018-01
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
RESORCINOL
HIDRADENITIS SUPPURATIVA
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration