Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere Health Condition 2: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Conditions
Interventions
Intervention1: oral sirolimus: oral sirolimus 0.8ng/m2 over 1 year
Control Intervention1: nil: nil
Sponsors
nil
Eligibility
Inclusion criteria
Inclusion criteria: Complex microcystic and macrocystic lymphatic malformations, venolymphatic or mixed malformations and or capillary malformations, vascular malformations associated overgrowth syndrome
Exclusion criteria
Exclusion criteria: Concurrent use of drug with cytochrome P450 3A4 inducer such as barbiturates, glucocorticoids, rifampicin, clarithromycin, and erythromycin. Immunosuppressed patient or patients known case of human immunodeficiency virus infection, ateriovenous and capillary malformations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to assess the percentage reduction in volume of vascular malformation at the end of 1 year of oral sirolimusTimepoint: baseline, 1 month, 3 months, 6 months, 9 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess time to attain resolution & safety of oral sirolimus in vascular malformationTimepoint: baseline, 1 month, 3 months, 6 months, 9 months & 12 months | — |
Countries
India
Contacts
Public ContactShreya K
MD Dermatology, senior resident, dept of dermatology, All India Institute of Medical Sciences, New Delhi
Outcome results
None listed