Study information for participants: Investigating a potential new treatment for Skin Cancer (BCC).
Quick Reference:
What is the purpose of this study?
Where is my nearest study site?
What is the purpose of this study?
This study aims to test a new treatment called FLD-103 to see how safe and effective it is for people with Basal Cell Carcinoma (BCC), a type of skin cancer.
Where is my nearest study site?
Here is a list of all of the sites who are currently recruiting for this study:
Who can participate?
To take part in this study, you will need to meet all the following (other criteria apply):
- Aged 18 to 85 years old
- At least one histologically confirmed diagnosis of nodular Basal Cell Carcinoma (nBCC) or a suspected Basal Cell Carcinoma (diagnosis can be confirmed during the Screening visit)
- Not currently participating in another clinical trial
Who cannot participate?
Unfortunately, if any of the following apply to you, this study is not the right fit for you:
- If you have a history of cancer (other than skin cancer) in the past 5 years .
- If you have received phototherapy within six months of the screening visit or planning to.
- If you are immunocompromised or undergoing treatments that suppress your immune system.
- If you have uncontrolled hypertension or abnormal ECG findings that may interfere with the study.
Please note, additional eligibility criteria apply.
What is involved?
If you are deemed eligible for the study, your participation is expected to last approximately 16 weeks, and you will be required to attend the study site up to 13 times. This includes:
- Screening Visit: To assess your eligibility, including medical history, vital signs, and physical examination.
- Treatment Visits: Intralesional administration of the investigational product, FLD-103, either as a single dose or multiple doses over the course of several weeks.
- Follow-up Visits: To monitor your health and assess any potential side effects or changes from baseline, including vital signs, laboratory tests, and lesion evaluations.
- Safety Monitoring: You will undergo regular safety checks, including laboratory tests and ECGs, to monitor your health throughout the study.
Participation in this research is voluntary, and you may withdraw from the study at any time.
If you take part in the research study, there will be:
- Reimbursement of costs; For out-of-pocket expenses, such as travel and parking.
- Convenience; There are no overnight stays.
- Free study-related medical care; Be among the first to access potential new research treatments before they are widely available.
- Expert medical monitoring; Receive top-tier medical care and monitoring from experienced healthcare professionals.
- Contribution to medical research; Help investigate a potential new treatment that could improve the lives of individuals with vitiligo.
What is Basal Cell Carcinoma (BCC)?
Basal Cell Carcinoma (BCC) is a type of skin cancer that starts in the basal cells, which are found at the bottom of the outer layer of your skin. BCC is the most common type of skin cancer, but it’s also one of the least dangerous. It usually grows slowly and rarely spreads to other parts of the body. However, if left untreated, it can cause damage to the surrounding skin and tissues.
BCC is most often caused by exposure to ultraviolet (UV) light from the sun or tanning beds. It typically appears on areas of the skin that get the most sun, like the face, back, and arms.
Why is this study important?
This study is important because Basal Cell Carcinoma (BCC) is the most common type of skin cancer, and while it’s often treatable, current treatment options aren’t always effective or convenient for everyone. By testing the new treatment, FLD-103, this study aims to find a safer and effective way to treat BCC.
If successful, this treatment could help improve outcomes for people with BCC, offering them a better, non-surgical option for managing the condition, especially for those whose cancer is harder to treat with traditional methods.
Who is involved?
This study is being sponsored by Feldan Bio Inc.
This trial has been approved by an independent ethics committee
Ready to register? Click here to sign up/login to Evrilink and start your clinical trial journey.
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