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Attivo ma non reclutanteFASE3INTERVENTISTICO

Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome

This study is testing a gel called Patidegib (2%) for adults who have a condition called Gorlin syndrome. People with Gorlin syndrome often get many skin cancers, called basal cell carcinomas (BCCs), especially on their face. The main goal of this study is to find out if applying Patidegib gel to the face twice a day can help prevent new BCCs from developing. It also aims to see if the gel is safe for people to use over a 12-month period. Some people will use the active Patidegib gel, while others will use a gel that looks the same but doesn't contain the active medicine. The researchers will then compare the number of new BCCs in both groups.

A colpo d'occhio

Stato
Attivo ma non reclutante
Fase
FASE3
Sponsor
Sol-Gel Technologies, Ltd.
Obiettivo di iscrizione
140
Inizio
17 Mar 2024
Completamento stimato
01 Ott 2026

Di cosa tratta questo studio?

This study is about helping adults who have a condition called Gorlin syndrome. People with Gorlin syndrome are more likely to develop certain types of skin cancer, called basal cell carcinomas (BCCs), especially on their face. These BCCs can be a real problem, often requiring treatments like surgery.

The study is testing a new gel, called Patidegib, to see if it can help prevent these new BCCs from forming. Half of the people taking part will use the Patidegib gel on their face twice a day for a year. The other half will use a 'dummy' gel, which looks exactly the same but doesn't contain the active medicine. This helps researchers compare the effects accurately. Everything is carefully monitored, and any new spots on the face that look like BCCs will be checked by experts.

The main idea is to find a way to reduce the number of skin cancers people with Gorlin syndrome get, which could potentially improve their quality of life and reduce the need for multiple treatments. This is a "Phase 3" study, which means it’s a big step towards potentially making this treatment available if it proves safe and effective.

Punti chiave

  • Tests a gel (Patidegib) to prevent new skin cancers (BCCs) in Gorlin syndrome.
  • Compares active gel to a 'dummy' gel over 12 months.
  • Involves applying gel twice daily and regular clinic visits.
  • Aims to reduce BCCs and improve quality of life.
  • Participants must be 18+ with Gorlin syndrome and facial BCCs.

Chi può essere idoneo?

To join this study, you need to be an adult, at least 18 years old. You must have been diagnosed with Gorlin syndrome and have a specific genetic change (called a PTCH1 mutation) confirmed by a doctor. You also need to have quite a few BCCs on your face – at least 10 – when you start the study. It's important that you're willing to only use the study gel on your face and avoid other skin creams or treatments, unless your study doctor says they are okay.

There are also some reasons why you wouldn't be able to join. For example, if you've recently used strong skin treatments on your face or other medications that might interfere with the study's results. If you're allergic to anything in the gel, or have another serious health condition that isn't under control, you wouldn't be able to participate. Also, if you've had certain types of cancer in the last five years, or if a previous similar treatment for Gorlin syndrome didn't work for you, you might not be eligible.

Questo studio potrebbe fare al caso tuo?

Rispondi a queste domande rapide per vedere se potresti essere idoneo. Questo è solo una guida — il team di ricerca prende la decisione finale.

  1. Hai almeno 18 anni?
  2. Do you have a confirmed diagnosis of Gorlin syndrome?
  3. Do you have at least 10 basal cell carcinomas on your face?
  4. Are you able to use only the study gel on your face for one year, unless prescribed by the study doctor?
  5. Have you not had certain other cancers or specific treatments recently?
Rispondi a ogni domanda per vedere il tuo risultato.

Cosa comporta la partecipazione?

If you join the study, you'll be given either the active Patidegib gel or a 'dummy' gel. You won't know which one you're receiving, and neither will your study doctor. You'll need to apply the gel to your face twice a day every day for 12 months. Throughout this year, you'll have regular visits to the clinic where study staff will check your skin for any new spots, photograph your face, and assess how the gel is working. They will also ask about any side effects you might be experiencing and perform some health checks. It's important to attend all appointments so the researchers can track your progress and safety. There will be ongoing checks of your skin to record any new BCCs that appear.

Rischi e benefici potenziali

Participating in this study might offer a potential benefit if you receive the active Patidegib gel and it helps reduce the number of new basal cell carcinomas on your face. This could mean fewer uncomfortable treatments like surgery. However, there's always a chance you might receive the dummy gel or that the active gel might not work for you. As with any medicine, there could be side effects, which the study team will discuss and carefully monitor. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (40)

  • Northwest Arkansas Clinical Trials Center
    Codice postale verificato
    Rogers, United States
  • Center for Dermatology Clinical Research
    Codice postale verificato
    Fremont, United States
  • University of California Los Angeles (UCLA) - Center for Inflammatory Bowel Diseases - Westwood Location
    Codice postale verificato
    Los Angeles, Stati Uniti
  • The Dermatology Center of Newport
    Codice postale verificato
    Newport Beach, Stati Uniti
  • Stanford University - Lucille Packard's Children's Hospital
    Codice postale verificato
    Redwood City, Stati Uniti
  • Università di Yale
    Codice postale verificato
    New Haven, Stati Uniti
  • Dermatology Associates of Tallahassee
    Codice postale verificato
    Tallahassee, Stati Uniti
  • University of South Florida Health
    Codice postale verificato
    Tampa, Stati Uniti
  • The University of Chicago Medicine
    Codice postale verificato
    Chicago, Stati Uniti
  • The Johns Hopkins Hospital
    Codice postale verificato
    Baltimora, Stati Uniti
  • University of Michigan Health - Michigan Medicine - University Hospital
    Codice postale verificato
    Ann Arbor, Stati Uniti
  • Minnesota Clinical Study Center
    Codice postale verificato
    New Brighton, United States

Domande comuni

What is Gorlin syndrome?

Gorlin syndrome is a rare genetic condition that can make people more likely to develop certain health issues, including a type of skin cancer called basal cell carcinoma (BCC).

What are basal cell carcinomas (BCCs)?

BCCs are the most common type of skin cancer. They usually grow slowly and rarely spread to other parts of the body, but can cause damage if left untreated.

What is a 'dummy' gel?

A 'dummy' gel looks exactly like the active medicine but doesn't contain any real drug. This helps researchers fairly compare the active gel's effects.

Per quanto tempo sarò nello studio?

You'll be in the study for a total of 12 months, during which you'll apply the gel twice daily and attend regular check-up appointments.

Can I stop the study if I want to?

Yes, you can leave the study at any time, for any reason, and your regular medical care will not be affected.

Come saperne di più

Parla sempre con il tuo medico di base o specialista prima di decidere di partecipare a uno studio.

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