Study ID: CA43-I7P-MC-DSAF for Hidradenitis Suppurativa
Summary
This study is to test the safety and effectiveness of an injectable medication in combination with a topical cream for symptoms of hidradenitis suppurativa.
Currently there are no single treatment for HS that works every time.
This is a placebo controlled trial. Volunteers will be divided into two groups. The first group will receive the active drug, while the second group will receive a placebo for only the first 16 weeks.
After 16 weeks, all volunteers will begin using the active study drug.
Study medicine and any trial-related
procedures are covered at no cost.
This study will assess the efficacy of the study drug to:
Reduce the lumps and pain from HS.
Improve peoples’
overall quality
of life
Volunteers are needed to help verify whether new treatments should be released to the public. Your participation in our clinical trial helps develop treatments that can help millions of people.
If you have HS that has not responded well to anti-biotics or you cannot tolerate them, and want to help us research innovative treatments by trying them with us, read on to the inclusion criteria.
There are other criteria that our clinical staff will discuss with you as well.
Inclusion Criteria
You may be eligible* to participate in the study if:
You are 18 to 75 years old.
You have been diagnosed with HS for at least 12 months before the trial begins.
You have HS in two areas of your body (at least one must be Hurley Stage 2)
You have not responded well, or are unable to tolerate, antibiotic treatments.
You have 5 or greater HS lumps or nodules.
* Additional criteria for eligibility apply
If study investigators determine you are eligible, your participation may help find a potential treatment option for you and others with HS
If you participate in the study, You will be asked to:**
Provide signed informed consent
Comply with all scheduled clinic
visits and study-related
procedures
Not take any study-prohibited
medications during the trial
period
** Additional responsibilities apply
Your participation in the study is entirely voluntary, and your information
will be confidential. If you change your mind, you can withdraw from the study at any
time, for any reason, and without any consequence
What to expect during the study
Beyond the initial screening period, the study lasts up to 67 weeks
consisting of frequent clinic visits to receive treatment and update on your health status, including:***
Routine laboratory
tests
Urinalysis
Physical Exam
Vital signs
Standard assessments for the effectiveness of the drug.
***Additional assessments apply
Contact us about joining the trial
To be eligible for this trial, applicants MUST have a skin condition. We DO NOT accept volunteers who do not have a skin disease.
Fill out this form to get in touch. We will contact you in 1-2 business days regarding your application to participate in the trial. You can also call us at #(289)-763-8666
Privacy Policy for SimcoDerm Clinical Trials
Your privacy is important to us, and we take the protection of your personal health information (PHI) seriously. This policy explains how we collect, use, and protect your information.
We collect information directly from you, including your name, contact details, health information, and treatment history.
We use your information to determine eligibility for clinical trials, manage appointments, and communicate with you about your participation in clinical trials.
Data Protection:
Your information is stored securely and is only accessible by authorized personnel. We use data encryption, conduct security audits, and implement strict access controls to ensure the protection of your personal information.
You have the right to access, amend, or request the deletion of your health records. To exercise these rights, send a request to our clinical trial support team.