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

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.

Study Overview

• Status: Unknown
• Conditions: HYDRADENITIS

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Jaime Cordero Ramos; Phone Number: 600162807; Email: jaime.cordero.sspa@juntadeandalucia.es
• Study Contact Backup: Name: Carlos García Pérez; Phone Number: 600 162 458; Email: administracion.eecc.hvm.sspa@juntadeandalucia.es

Study Locations

• Spain
  • Sevilla, Spain, 41009
    • Recruiting
    • Hospital Universitario Virgen Macarena
    • Contact: David Moreno Ramírez; Phone Number: 955 00 80 00

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the change in the disease severity	Score change in the Hidradenitis Sartorius modified score	Up to 16 weeks

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Investigators: Principal Investigator: David Moreno Ramírez, Hospital Universitario Virgen Macarena

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2019
• Primary Completion (ANTICIPATED): April 30, 2020
• Study Completion (ANTICIPATED): August 30, 2020

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (ACTUAL): September 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: RESORCINOL; HIDRADENITIS SUPPURATIVA
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: FIS-RES-2018-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No