Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1)
This study is investigating a new cream for a skin condition called hidradenitis suppurativa (HS). HS causes painful lumps under the skin. The cream, called ruxolitinib, is being tested to see how effective and safe it is for people with mild to moderate HS. Participants will be split into groups; some will use the active ruxolitinib cream, while others will use a 'vehicle cream' – this looks the same but doesn't contain the active medicine. This helps researchers compare the effects accurately. The study is a Phase 3 trial, which means it's a larger study that follows earlier successful tests and is often a step towards a new treatment becoming widely available.
Auf einen Blick
Worum geht es in dieser Studie?
Hidradenitis Suppurativa (HS) is a long-term skin condition that causes painful lumps and abscesses, often in places like the armpits, groin, and under the breasts. It can be uncomfortable and impact daily life. Doctors are always looking for better ways to manage HS and ease symptoms. This particular study is testing a new cream called ruxolitinib to see if it can help people with HS.
Think of this study as a careful test to understand if ruxolitinib cream is a useful treatment for HS. Researchers want to find out two main things: first, how well the cream works to improve HS symptoms (this is called 'efficacy'), and second, whether it causes any unwanted side effects (this is called 'safety'). If the cream proves to be both effective and safe, it could become a new treatment option for people living with HS in the future.
Taking part in a study like this is important because it helps medical science advance. Every new treatment starts with research, and patient volunteers are essential to figuring out which treatments work best. This particular study focuses on people with milder to moderate forms of HS, and it's looking specifically at a cream that you apply to the skin.
Wichtige Erkenntnisse
- This study is testing a new cream (ruxolitinib) for hidradenitis suppurativa (HS).
- It's for people with mild to moderate HS, aiming to see how well the cream works and if it's safe.
- Participants will use either the active cream or a 'dummy' cream.
- You'll need regular clinic visits and agree to certain restrictions on other HS treatments.
- Participation helps advance research into better HS treatments.
- Sie können die Teilnahme jederzeit beenden.
Wer könnte berechtigt sein?
To join this study, you would need to have been diagnosed with hidradenitis suppurativa (HS) for at least six months. Your HS should be considered mild to moderate, meaning you have certain types of lumps (Doctors call these lesions 'AN count') in at least two different body areas, but without any deep draining tunnels.
There are also some things that might mean you can't join. For example, if your HS covers a very large area of your body, or if you have those deep draining tunnels. You also can't be pregnant or breastfeeding, or planning to become pregnant during the study. Additionally, if you have certain other health conditions, infections, or issues with your blood tests, you might not be able to take part.
Könnte diese Studie für Sie geeignet sein?
Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.
- Have you been diagnosed with hidradenitis suppurativa for at least 6 months?
- Is your HS considered mild to moderate (Hurley I or II) without deep draining tunnels?
- Do you have lumps (AN count) in at least two different spots?
- Are you able to avoid using certain other HS treatments during the study?
- Are you currently pregnant or breastfeeding, or planning to become so during the study?
- Does your HS affect less than 20% of your total body surface area?
Was beinhaltet die Teilnahme?
If you join the study, you'll be given either the ruxolitinib cream or a 'dummy' cream (vehicle cream) to apply to your skin. You'll need to agree not to use certain other creams, washes, or strong medicines (like antibiotics) for your HS during the first part of the study, so doctors can properly see how the study cream works. You will have regular visits to the clinic so the study team can check your skin, record your symptoms, and make sure you're doing well. These visits will involve physical examinations and possibly blood tests. The study will last for a certain period, and you'll get detailed information about the schedule of visits and what each visit involves before you decide to take part. The exact number of visits and the total duration would be explained by the study team.
Potenzielle Risiken und Vorteile
Locations (101)
- Investigative Site US020Verifizierte PostleitzahlPhoenix, Vereinigte Staaten· Rekrutierung
- Investigative Site US033Verifizierte PostleitzahlScottsdale, Vereinigte Staaten· Rekrutierung
- Investigative Site US054Verifizierte PostleitzahlTempe, United States· Rekrutierung
- Investigative Site US002Verifizierte PostleitzahlFayetteville, Vereinigte Staaten· Rekrutierung
- Investigative Site US055Verifizierte PostleitzahlBrea, United States· Rekrutierung
- Investigative Site US004Verifizierte PostleitzahlLaguna Niguel, United States· Rekrutierung
- Investigative Site US007Verifizierte PostleitzahlLos Angeles, Vereinigte Staaten· Rekrutierung
- Investigative Site US013Verifizierte PostleitzahlSan Diego, Vereinigte Staaten· Rekrutierung
- Investigative Site US060Verifizierte PostleitzahlSan Diego, Vereinigte Staaten· Rekrutierung
- Investigative Site US038Verifizierte PostleitzahlSan Diego, Vereinigte Staaten· Rekrutierung
- Investigative Site US059Verifizierte PostleitzahlAurora, Vereinigte Staaten· Rekrutierung
- Investigative Site US045Verifizierte PostleitzahlBoynton Beach, United States· Rekrutierung
Häufige Fragen
Was ist Hidradenitis suppurativa (HS)?
HS is a chronic skin condition that causes painful, often recurring, lumps and abscesses in parts of the body where skin rubs together, like the armpits or groin.
Was ist Ruxolitinib-Creme?
It's a cream being tested to see if it can help improve symptoms of HS. It's not yet approved for general use for HS.
What does 'Phase 3' mean for a clinical trial?
Phase 3 means it's a larger study, following earlier successful tests, to confirm if the treatment is effective and safe before it can be considered for wider use.
Will I definitely get the active cream?
Not necessarily. In this type of study, some participants receive the active ruxolitinib cream, while others receive a 'dummy' cream (vehicle cream) for comparison.
Can I use my usual HS medicines during the study?
No, during parts of the study, you would need to agree not to use other common topical or systemic HS treatments like antibiotics on the affected areas, so the study cream's effects can be clearly seen.
Wie Sie mehr erfahren können
Incyte Corporation Callcenter (USA)
Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.
Interessiert daran, teilzunehmen?
Diskussion
Community-Diskussion
Bereitgestellt von unserem Forum bei community.patient.info. Bitte seien Sie respektvoll — dies ist kein medizinischer Rat.