HYDRADENITISNCT04099212
15% TOPICAL RESORCINOL FOR HURLEY I-II HIDRADENITIS SUPPURATIVA.
An observational study of HYDRADENITIS, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HYDRADENITIS
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2019to 30 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Age < 18 years.
- Number of draining fistula above 20.
- Patients in active treatment with immunomodulators.
- Patients in active treatment with antibiotics.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
David Moreno Ramírez, 955 00 80 00
About this study
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.
- Conditions
- HYDRADENITIS
- Keywords
- RESORCINOL, HIDRADENITIS SUPPURATIVA
- Medical subject headings
- Hidradenitis, Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with HS I-II in monotherapy treatment of topical resorcinol 15% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the change in the disease severity
Score change in the Hidradenitis Sartorius modified score
Measured: Up to 16 weeks
Secondary outcomes (7)
Usage profile
Descriptive measurement of demographic and clinical variables (central tendency, dispersion and distribution of tendencies) prior to the start of treatment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 16 weeks
Evaluate the change in the disease severity.
Score change in the Physician Global Assesment scale for Supurative Hidradenitis
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start15 May 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HYDRADENITISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Moreno Ramírez, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099212
- Sponsor's protocol ID
- FIS-RES-2018-01
- Status last verified
- Apr 2019
- First submitted
- 9 Sep 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OBSERVATIONAL CASE-ONLY PROSPECTIVE STUDY OF EFFECTIVENESS AND SAFETY OF 15% TOPICAL RESORCINOL FOR ADULTS WITH HURLEY I-II HIDRADENITIS SUPPURATIVA.
- ClinicalTrials.gov ID
- NCT04099212
- Acronym / sponsor ID
- FIS-RES-2018-01
- Conditions
- HYDRADENITIS
- Keywords
- RESORCINOL, HIDRADENITIS SUPPURATIVA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Patients with HS I-II in monotherapy treatment of topical resorcinol 15% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Age < 18 years.
- Number of draining fistula above 20.
- Patients in active treatment with immunomodulators.
- Patients in active treatment with antibiotics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the change in the disease severity
Time frame: Up to 16 weeks
Score change in the Hidradenitis Sartorius modified score
7 secondary outcomes
Usage profile
Time frame: Initial
Evaluate the security of the treatment
Time frame: Up to 16 weeks
Evaluate the changes in the patient´s quailty of life due to the treatment
Time frame: Up to 16 weeks
Evaluate the changes in the patient´s quailty of life due to the treatment 2
Time frame: Up to 16 weeks
Total and partial ultrasound responders frequency of distribution.
Time frame: Up to 16 weeks
Evaluate the frequency of responders
Time frame: Up to 16 weeks
Evaluate the change in the disease severity.
Time frame: Up to 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
Related trials for HYDRADENITIS
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Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Moreno Ramírez principal investigator
Hospital Universitario Virgen Macarena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HYDRADENITIS, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaime Cordero Ramos (600162807, jaime.cordero.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the change in the disease severity (time frame: Up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.