EUCTR2011-006308-12-ES
Active, not recruiting
Not Applicable
phase II clinical trial, to study the efficacy and safety of topical rapamycin in reducing facial angiofibromas.
Fundación Investigación Hospital Ramón y Cajal0 sitesMarch 29, 2012
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fundación Investigación Hospital Ramón y Cajal
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Patients, who, after receiving information about the design, the purpose of the study, the potential risks it can occur and that at any time may refuse your help, give written consent to participate in the study and for the provision material for cellular and molecular studies.
- •\-Subject is male or female and over 13 years of age.
- •\-Subject has a diagnosis of TSC and has visible fibromatosus lesions (angiofibromas or angifibromata)
- •\-women of childbearing age should get a negative pregnancy test the screening visit; further agree to use adequate contraception (among them are considered: double barrier as condom \+ diaphragm, surgical sterilization) within 14 days following administration of study drug.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 25
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 25
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\.Pregnant, intention to become pregnant during treatment phase of the trial, or breastfeeding.
- •2\. Patient is currently participating or has participated within the last two months in any clinical trial.
- •3\.Patient is actually receiving or has received in the last three mounths any m\-TOR inhibitor treatment or any form of immunosuppression drug.
- •4\. Hypersensitivity to rapamycin
- •5\.Any serious medical or psychiatric illness currently ongoing, or experienced within the past three months, that in the opinion of the investigator would compromise the study
Outcomes
Primary Outcomes
Not specified
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