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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01826201 | Paired Psoriasis Lesion, Comparative, Study to Evaluate MOL4239 in Psoriasis | PHASE2 | COMPLETED | 21 | — | — | Mar 1, 2013 | Aug 1, 2013 | Dec 24, 2014 | 3 | United States |
he study drug application sites were scored for erythema, induration, and scale assessment using the PSS Scoring system. Psoriasis Severity Score (PSS) Erythema 0 - 4, 0 None, may have residual non-erythematous discoloration 1 Faint erythema 2 Moderate erythema/red color 3 Severe erythema/very red discoloration 4 Very severe erythema/extreme red coloration Induration 0 - 4 0 None 1. Trace or slight elevation of plaque above normal skin level 2. Moderate elevation with rounded or sloped edges to plaque 3. Marked elevation with hard, sharp edges to plaque 4. Very marked elevation with very hard, sharp edges to plaque Scaling 0 - 4 0 None 1. Fine scales 2. Coarse scales 3. Thick scales with a rough surface 4. Thick scales with a very rough surface The scores were summed
| Arm | Type | Description |
|---|---|---|
| 10% MOL4239 ointment & placebo ointment | EXPERIMENTAL | 10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days |
| Name | Type | Description |
|---|---|---|
| MOL4239 | DRUG | 10% MOL4239 ointment to one target lesion twice a day for 28.5 consecutive days |
| Placebo | DRUG | placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days |
Inclusion Criteria: * Adults, males or females, 18 to 72 years of age (both inclusive.) * Mild to moderate plaque psoriasis with lesions that in total are no more than 9.9% BSA and with a baseline Psoriasis Severity Score (PSS) of 6 or more. * Identification of bilaterally symmetrical or approximat...