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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00817063 | Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema | PHASE3 | COMPLETED | 599 | — | — | Jan 8, 2009 | Apr 26, 2012 | Apr 27, 2020 | 70 | United States |
The investigator assigned PGA grades according to a 5-point scale (clear \[not detectable\], almost clear \[less than 10% of affected hand surface\], mild disease \[less than 10% of affected hand surface\], moderate disease \[10% to 30% of affected hand surface\], severe disease \[\>30% of affected hand surface\]). PGA ratings were based on an integrated clinical picture of signs, symptoms, and the extent of disease. Symptoms included erythema, scaling, hyperkeratosis/lichenification, vesiculation, edema, fissures, and pruritus/pain. The PGA scale ranges from 0 (no symptom) to 4 (severe disease). Participants were considered as responders when they had a PGA of clear or almost clear.
| Arm | Type | Description |
|---|---|---|
| Alitretinoin | EXPERIMENTAL | Patients will receive alitretinoin 30mg capsule for up to 24 weeks |
| Placebo | EXPERIMENTAL | Patients will receive placebo 30mg capsule for up to 24 weeks |
| Name | Type | Description |
|---|---|---|
| alitretinoin | DRUG | Patients receive alitretinoin 30mg one capsule daily for up to 24 weeks |
| Placebo | DRUG | Patients receive matching placebo for up to 24 weeks |
Inclusion Criteria: * all types of chronic hand eczema, lasting for at least 6 months since initial diagnosis * rated as severe by the physician * unresponsive to highly potent topical corticosteroids, such as clobetasol Exclusion Criteria: * patients whose disease is adequately controlled by sta...