CClinicalTrials.gg
Status unknownNCT04099212Updated Feb 12, 2020

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

An observational study in HYDRADENITIS, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-12.

Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Observational

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • HYDRADENITIS

Keywords

  • RESORCINOL
  • HIDRADENITIS SUPPURATIVA
03

In context

Hidradenitis Suppurativa

277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.

This study's planned enrollment of 40 is below the median of 142 across 69 observational studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 119 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

Exclusion Criteria:

  • Age \< 18 years.
  • Number of draining fistula above 20.
  • Patients in active treatment with immunomodulators.
  • Patients in active treatment with antibiotics.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cases

    Patients with HS I-II in monotherapy treatment of topical resorcinol 15%

06

What researchers measure

Primary outcomes

  1. Evaluate the change in the disease severity

    Score change in the Hidradenitis Sartorius modified score

    Time frame: Up to 16 weeks

Secondary outcomes

  1. Usage profile

    Descriptive measurement of demographic and clinical variables (central tendency, dispersion and distribution of tendencies) prior to the start of treatment.

    Time frame: Initial

  2. 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.

    Time frame: Up to 16 weeks

  3. 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.

    Time frame: Up to 16 weeks

  4. 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.

    Time frame: Up to 16 weeks

  5. 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.

    Time frame: Up to 16 weeks

  6. 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.

    Time frame: Up to 16 weeks

  7. Evaluate the change in the disease severity.

    Score change in the Physician Global Assesment scale for Supurative Hidradenitis

    Time frame: Up to 16 weeks

07

Study locations

1 of 1 sites recruiting
  • Hospital Universitario Virgen Macarena
    Sevilla, 41009, Spain
    • David Moreno Ramírez · Contact · 955 00 80 00
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04099212
Lead sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Responsible party
Sponsor
First posted
Sep 23, 2019
Start date
May 15, 2019
Primary completion
Apr 30, 2020 (estimated)
Completion
Aug 30, 2020 (estimated)
Last update
Feb 12, 2020

Study contacts

Jaime Cordero Ramos
Contact
jaime.cordero.sspa@juntadeandalucia.es
600162807
Carlos García Pérez
Contact
administracion.eecc.hvm.sspa@juntadeandalucia.es
600 162 458
David Moreno Ramírez
principal investigator · Hospital Universitario Virgen Macarena

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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