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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06561321 | Study to Evaluate the Safety and Efficacy of Tapinarof in Adults With Palmoplantar Keratoderma | PHASE2 | RECRUITING | 6 | — | — | Oct 30, 2024 | Dec 31, 2027 | Mar 4, 2026 | 1 | United States |
To evaluate the treatment benefit of Tapinarof applied topically to patients affected with palmoplantar keratoderma. Either an overall change in the PGA score to 0 (clear) or 1 (almost clear) or a decrease from baseline of at least 2 points. Higher scores indicate a worse outcome. Title: PHYSICIAN GLOBAL ASSESSMENT Minimum value: 0 Maximum value: 5
| Arm | Type | Description |
|---|---|---|
| Tapinarof Drug Treatment | EXPERIMENTAL | Subjects in this arm will apply Tapinarof 1% cream topically once daily for a 16-week open-label treatment period. Participants who achieve disease clearance after 16 weeks may discontinue treatment and will be monitored for sustained response up to 52 weeks. Those who do not achieve clearance will continue the treatment during an extension period for up to 36 additional weeks or until clearance is achieved, whichever comes first. Regular follow-up visits will assess the duration of disease clearance and monitor for any potential recurrence of keratoderma. |
| Name | Type | Description |
|---|---|---|
| Tapinarof | DRUG | Daily topical Tapinarof use will stop disease advancement and improve the quality of life in patients with palmoplantar keratoderma, through its AhR \& NRF2 agonism properties. |
Inclusion Criteria: * Ability to discern and provide written informed consent and voluntarily adhere to all of the protocol requirements * Male or female subjects in their adult years (≥ 18 years of age), inclusive, from the time of providing written subject-investigator agreement. * Confirmed clin...