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Label indication Pimecrolimus Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. FDA label
Also known as Pimecrolimus Cream 1%, Pimecrolimus 1%, Elidel, ASM981
Pimecrolimus · 7 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Pimecrolimus |
| 2 | PLACEBO_COMPARATOR | Vehicle |
| Pimecrolimus 0.3% | EXPERIMENTAL | ASM981 0.3% |
| Pimecrolimus 1% | EXPERIMENTAL | ASM981 1% |
| Vehicle with carbopol | PLACEBO_COMPARATOR | - |
| Vehicle without carbopol | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Pimecrolimus | DRUG | Pimecrolimus cream 1 % |
| Placebo | DRUG | Vehicle cream (placebo) |
| Pimecrolimus Cream 1% | DRUG | - |
| pimecrolimus and clobetasol | DRUG | - |
| clobetasol 0.05% cream | DRUG | twice daily for three months |
| Vehicle | DRUG | Placebo |
Inclusion Criteria: * clinically diagnosed perioral dermatitis associated or not associated with topical steroid use (the periorbital area may also be involved in addition to the perioral region) * minimum severity score (PODSI) ≥ 4 * age 18 and older Exclusion Criteria: * Ongoing use of the foll...
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Pimecrolimus is a topical small-molecule therapy studied for inflammatory skin conditions, including atopic dermatitis, chronic hand dermatitis, perioral dermatitis, and lichen sclerosus. It has also been investigated in keratoconjunctivitis sicca. Clinical development has focused on dermatology, with trials in pediatric and adult patients.
Pimecrolimus is an inhibitor that binds to the molecular target FKBP1A. By interacting with FKBP1A, it modulates calcineurin-dependent signaling in T cells, reducing the release of inflammatory cytokines. This mechanism underlies its topical anti-inflammatory activity in conditions such as atopic dermatitis and other dermatologic disorders.
Pimecrolimus is developed by Novartis AG, which trades under the ticker NVS. Novartis has sponsored clinical trials of the drug across several dermatologic indications, including atopic dermatitis, perioral dermatitis, and lichen sclerosus.
Pimecrolimus is in Phase 3 development. The program includes completed Phase 3 trials in atopic dermatitis and perioral dermatitis, as well as a completed Phase 2 trial in lichen sclerosus. No active trials are currently listed, and all three completed studies have finished.
Pimecrolimus has been evaluated in completed trials including NCT00393263 (clobetasol versus pimecrolimus for vulvar lichen sclerosus), NCT00351052 (steroid-sparing effect in pediatric atopic dermatitis), NCT00232115 (Pimecrolimus Cream 1% in adult perioral dermatitis), and NCT00232011 (an extension study in adult atopic dermatitis).