Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00120523 | 5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis | PHASE3 | COMPLETED | 2,418 | — | — | Apr 1, 2004 | Oct 1, 2010 | Feb 11, 2022 | 31 | United States, Germany |
| NCT03107611 | Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis | PHASE3 | COMPLETED | 654 | — | — | Feb 29, 2016 | May 15, 2017 | Mar 7, 2022 | 27 | United States, Dominican Republic +1 |
crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period
number (%) of patients with positive antibody titers to tetanus, hepatitis B, and measles vaccines at baseline, weeks 26 (6 months), 52 (1 year), 104 (2 years), 156 (3 years), 208 (4 years) and 260 (5 years) Varicella antibody titers were measured at the above time points in US patients only.
Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting
Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Pimecrolimus |
| 2 | ACTIVE_COMPARATOR | Topical corticosteroids |
| Test | EXPERIMENTAL | Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days |
| Reference Standard | ACTIVE_COMPARATOR | Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days |
| Placebo | PLACEBO_COMPARATOR | Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days |
| Name | Type | Description |
|---|---|---|
| Pimecrolimus | DRUG | Pimecrolimus cream 1 % |
| Topical corticosteroids | DRUG | TCS |
| Pimecrolimus Cream, 1% | DRUG | - |
| Placebo Cream | DRUG | - |
Inclusion Criteria: * Aged 3 to \< 12 months * Diagnosis of AD fulfilling the diagnostic criteria of Seymour * AD affecting at least 5% total body surface area * Investigator's Global Assessment (IGA) score of 2 or 3, corresponding to mild-to-moderate disease at baseline * Informed consent Exclusi...