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Arm 1 for Tuberous Sclerosis
Study Summary
This trial is testing a possible treatment for a skin condition called angiofibromas, which is caused by a genetic disorder called tuberous sclerosis complex.
- Tuberous Sclerosis
- Facial Angiofibromas
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Who meets the eligibility criteria to participate in this research project?
"This clinical study seeks 45 participants with adenoma sebaceum aged between 2 and 21. It is essential that applicants have 3 or more facial angiofibromas of grade ≥2 colour for each lesion, agree to abstain from intercourse or use an accepted form of birth control if their partner does not get a vasectomy, be in good health based on medical history/physical exam results, and are willing/able to comply with trial requirements."
What past research has been conducted on the first arm of this experiment?
"Presently, Arm 1 has 125 ongoing studies with 13 of them in the third phase. Of these trials some are occurring within Cincinnati, Ohio while 1074 sites across the globe host clinical trials for this arm."
What safety precautions have been taken with respect to participants in Arm 1?
"We rate Arm 1's safety at 2, as Phase 2 trials have generated some data affirming security without the same level of evidence for efficacy."
What is the intake capacity for this research initiative?
"The prerequisite number of eligible participants needed to commence the trial is 45. Aucta Pharmaceuticals, Inc will be managing recruitment and administration from multiple sites including Children's Hospital of Los Angeles' Division of Neurology in LA and Boston Children's Hospital in Massachusetts."
Which ailments are typically targeted with Arm 1 treatments?
"Rejection of a transplanted liver is typically handled with Arm 1, which is also suitable for treating disease, kidney issues and renal angiomyolipomas."
Is the current experiment open to individuals aged 55 and above?
"Per the rules of this medical experiment, participants must be no older than 21 years old and at least 2 years old."
Are there vacancies for prospective participants in this clinical experiment?
"According to clinicaltrials.gov, this research is currently recruiting participants with the initial posting date being April 12th 2017 and modifications made on February 2nd 2022."
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