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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This is a phase 2A clinical trial designed to test the pro-melanogenic and anti-inflammatory role of phosphodiesterase-4 inhibitors (PDE4i), alone and in combination with active narrow band UVB (NBUVB), in vitiligo lesions. This is a double-blind, randomized controlled trial (RCT) with six study arms. The goal is for 64 participants to be recruited and complete the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active NBUVB plus Crisaborole 2% topical ointment | Experimental | 12 participants will receive 6 months of treatment with crisaborole 2% topical along with 6 months of treatment with active NBUVB |
|
| Active NBUVB plus PF-07038124 0.01% topical ointment | Experimental | 12 participants will receive 6 months of treatment with active NBUVB, to be combined with 3 months of treatment with PF-07038124 0.01% topical ointment followed by 3 months of vehicle ointment |
|
| Active NBUVB plus vehicle ointment | Active Comparator | 8 participants will receive 6 months of treatment with active NBUVB combined with 6 months of vehicle ointment application |
|
| Sham phototherapy plus crisaborole 2% topical ointment | Experimental | 12 participants will receive 6 months of treatment with crisaborole 2% topical ointment combined with 6 months of sham phototherapy |
|
| Sham phototherapy plus PF-07038124 0.01% topical ointment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crisaborole 2 % Topical Ointment | Drug | Twice daily crisaborole 2% topical ointment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving at 50% or greater improvement from baseline in facial Vitiligo Area Scoring Index (F)-VASI | Assessment of facial repigmentation via changes in depigmented areas | 6 months (week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving 90% or greater improvement from baseline in F-VASI | 6 months (week 24) | |
| Proportion of participants achieving 50% or greater improvement from baseline in total (T)-VASI | 6 months (week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of pigment via Fontana-Masson staining | Molecular outcome: using skin biopsies treated with PDE4i with/without active NBUVB | Baseline (day 0, pre-treatment) and 3 months (12 weeks) |
| Assessment of melanocyte population expansion via immunohistochemistry (IHC) studies |
Inclusion Criteria:
Active or stable non-segmental vitiligo at Screening and Baseline visits:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanca Birlea, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz - Clinical and Translational Research Centers | Aurora | Colorado | 80045 | United States |
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Double-blind
12 participants will receive 3 months of treatment with PF-07038124 0.01% topical ointment, followed by 3 months of vehicle ointment, along with 6 months of sham phototherapy |
|
| Sham phototherapy plus vehicle ointment | Placebo Comparator | 8 participants will receive 6 months of sham phototherapy combined with 6 months of vehicle ointment application |
|
|
| PF-07038124 0.01% topical ointment | Drug | Twice daily PF-07038124 0.01% topical ointment |
|
| NBUVB phototherapy | Device | Home narrow band UVB phototherapy exposure sessions 3 times per week |
|
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| Sham phototherapy | Device | Non-NBUVB visible light radiation exposure sessions 3 times per week |
|
| Vehicle | Drug | Twice daily vehicle ointment |
|
| Proportion of participants achieving a Vitiligo Noticeability Scale (VNS) rating of "a lot less noticeable" or "no longer noticeable" | 6 months (week 24) |
| Percentage change from baseline in facial segment of Body Surface Area affected (F-BSA) | 6 months (24 weeks) |
Molecular outcome: using skin biopsies treated with PDE4i with/without active NBUVB |
| Baseline (day 0, pre-treatment) and 3 months (12 weeks) |
| Assessment of percent change from baseline in serum key inflammatory chemokines | Molecular outcome: using samples for serum measurements of IFN-gamma, IL-15, CXCL-9, CXCL-10, which have been implicated in vitiligo pathogenesis | Baseline (pre-treatment) and at 3 months (12 weeks) and 6 months (24 weeks) |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 10, 2026 | Feb 27, 2026 | 5 | ||
| Apr 1, 2026 | Apr 22, 2026 | 6 |
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C543085 | crisaborole |
| D009824 | Ointments |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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