Hidradenitis SuppurativaNCT06201858
A Journey Into Participation Patterns Among Patients With Hidradenitis Suppurativa
An observational study of Hidradenitis Suppurativa, run by Power Life Sciences Inc. at 1 site in United States.
Trial summary
This study aims to uncover the factors driving patient decisions regarding enrollment, withdrawal, or re-engagement in hidradenitis suppurativa clinical trials. Understanding these factors will significantly improve the relevance and effectiveness of future research endeavors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 with hidradenitis suppurativa who are actively considering enrolling in a clinical study for said condition, but have not yet completed enrollment and randomization.
Who may be able to join
- Aged ≥ 18 years old
- Diagnosis of hidradenitis suppurativa
- Able to comprehend the investigational nature of the protocol and provide informed consent
Who cannot join
- Female patients who are currently pregnant or nursing
- Inability to perform regular electronic reporting
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Power Life Sciences
San Francisco, California, 94107
Michael B Gill, 415-900-4227, https://www.withpower.com/contact-us@withpower.com
About this study
Official title: Examining Engagement Trends Among Participants in Hidradenitis Suppurativa Clinical Trials
This study aims to uncover the factors driving patient decisions regarding enrollment, withdrawal, or re-engagement in hidradenitis suppurativa clinical trials. Understanding these factors will significantly improve the relevance and effectiveness of future research endeavors.
Ultimately, this trial endeavors to deepen our understanding of the factors impacting hidradenitis suppurativa clinical trial participation. Enhancing participation rates could accelerate the development of innovative treatments for this debilitating condition.
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa
- Medical subject headings
- Hidradenitis Suppurativa
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hidradenitis suppurativa patients who decide to enroll in a clinical research
Measured: 3 months
Rate of hidradenitis suppurativa patients who remain in clinical trial to trial completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study startJan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- 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 crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201858
- Sponsor's protocol ID
- 67172350
- Status last verified
- Feb 2024
- First submitted
- 29 Dec 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Saunte DML, Jemec GBE. Hidradenitis Suppurativa: Advances in Diagnosis and Treatment. JAMA. 2017 Nov 28;318(20):2019-2032. doi: 10.1001/jama.2017.16691.
PubMed 29183082Garcovich S, Fania L, Caposiena D, Giovanardi G, Chiricozzi A, De Simone C, Tartaglia C, Ciccone D, Bianchi L, Abeni D, Peris K. Pediatric Hidradenitis Suppurativa: A Cross-Sectional Study on Clinical Features and Treatment Approaches. J Cutan Med Surg. 2022 Mar-Apr;26(2):127-134. doi: 10.1177/12034754211039993. Epub 2021 Oct 6.
PubMed 34615396Jfri A, Nassim D, O'Brien E, Gulliver W, Nikolakis G, Zouboulis CC. Prevalence of Hidradenitis Suppurativa: A Systematic Review and Meta-regression Analysis. JAMA Dermatol. 2021 Aug 1;157(8):924-931. doi: 10.1001/jamadermatol.2021.1677.
PubMed 34037678
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Engagement Trends Among Participants in Hidradenitis Suppurativa Clinical Trials
- ClinicalTrials.gov ID
- NCT06201858
- Acronym / sponsor ID
- 67172350
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 11 Jan 2024 (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.
This study aims to uncover the factors driving patient decisions regarding enrollment, withdrawal, or re-engagement in hidradenitis suppurativa clinical trials. Understanding these factors will significantly improve the relevance and effectiveness of future research endeavors.
Ultimately, this trial endeavors to deepen our understanding of the factors impacting hidradenitis suppurativa clinical trial participation. Enhancing participation rates could accelerate the development of innovative treatments for this debilitating condition.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hidradenitis suppurativa who are actively considering enrolling in a clinical study for said condition, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- Aged ≥ 18 years old
- Diagnosis of hidradenitis suppurativa
- Able to comprehend the investigational nature of the protocol and provide informed consent
Key exclusion criteria (3 listed)
- Female patients who are currently pregnant or nursing
- Inability to perform regular electronic reporting
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
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
Number of hidradenitis suppurativa patients who decide to enroll in a clinical research
Time frame: 3 months
Rate of hidradenitis suppurativa patients who remain in clinical trial to trial completion
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Background: PubMed 29183082Saunte DML, Jemec GBE. Hidradenitis Suppurativa: Advances in Diagnosis and Treatment. JAMA. 2017 Nov 28;318(20):2019-2032. doi: 10.1001/jama.2017.16691.
- Background: PubMed 34615396Garcovich S, Fania L, Caposiena D, Giovanardi G, Chiricozzi A, De Simone C, Tartaglia C, Ciccone D, Bianchi L, Abeni D, Peris K. Pediatric Hidradenitis Suppurativa: A Cross-Sectional Study on Clinical Features and Treatment Approaches. J Cutan Med Surg. 2022 Mar-Apr;26(2):127-134. doi: 10.1177/12034754211039993. Epub 2021 Oct 6.
- Background: PubMed 34037678Jfri A, Nassim D, O'Brien E, Gulliver W, Nikolakis G, Zouboulis CC. Prevalence of Hidradenitis Suppurativa: A Systematic Review and Meta-regression Analysis. JAMA Dermatol. 2021 Aug 1;157(8):924-931. doi: 10.1001/jamadermatol.2021.1677.
- Individual participant dataSharing planned: Undecided
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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.
Michael B Gill study director
Power Life Sciences Inc.
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 Hidradenitis Suppurativa, run by Power Life Sciences Inc. at 1 site in United States.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 12 Feb 2024. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (415-900-4227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hidradenitis suppurativa patients who decide to enroll in a clinical research (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06201858, which also lists 3 linked publications.
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 2024.