Clinical trial in patients with tuberous sclerosis for the study of the effects of topical rapamycin in reducing facial tumors associated with the disease ..
- Conditions
- Facial tumors (angiofibromas) associated with tuberous sclerosis complex.Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2011-006308-12-ES
- Lead Sponsor
- Fundación Investigación Hospital Ramón y Cajal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
-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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method