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pimecrolimus and clobetasol · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | pimecrolimus |
| 2 | ACTIVE_COMPARATOR | clobetasol |
| Name | Type | Description |
|---|---|---|
| pimecrolimus and clobetasol | DRUG | - |
| clobetasol 0.05% cream | DRUG | twice daily for three months |
Inclusion Criteria: * Female, 18 years or older. * With a diagnosis of biopsy proven active vulvar lichen sclerosus. * Signed written informed consent. * Willingness and ability to comply with the study requirements. * Negative urine pregnancy tests must be documented for all females of childbearin...
Pimecrolimus is a small molecule being developed by Novartis AG for dermatological conditions. It is studied for Lichen Sclerosus, Perioral Dermatitis, Chronic Hand Dermatitis, Keratoconjunctivitis Sicca, and Atopic Dermatitis. Clinical trials have evaluated it in forms such as a cream and an ophthalmic suspension.
Pimecrolimus is developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The drug is a small molecule in the dermatology therapeutic area, with completed clinical trials across multiple indications.
Pimecrolimus is in Phase 3 clinical development. It has completed Phase 3 trials for Chronic Hand Dermatitis and Atopic Dermatitis, and Phase 2 trials for Keratoconjunctivitis Sicca and Lichen Sclerosus. It remains investigational and is not approved for these uses.
Pimecrolimus has completed several clinical trials. NCT00226707 studied the cream in Chronic Hand Dermatitis, NCT00231998 was an extension study in pediatric Atopic Dermatitis, NCT00128245 tested an ophthalmic suspension in Keratoconjunctivitis Sicca, and NCT00393263 compared it to clobetasol in vulvar Lichen Sclerosus.
Pimecrolimus is the active ingredient in Elidel, a brand name for the 1% cream used to treat atopic dermatitis. The clinical trials listed include studies of pimecrolimus cream in various dermatological conditions, and the drug is also being investigated in other formulations.