VitiligoPhase 2NCT05298033
Study of Efficacy, Safety and Tolerability of Crisaborole and PF-07038124 With and Without NBUVB in Vitiligo
A Phase 2 study testing Crisaborole 2 % Topical Ointment, PF-07038124 0.01% topical ointment and NBUVB phototherapy in people with Vitiligo, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Crisaborole 2 % Topical Ointment, PF-07038124 0.01% topical ointment and NBUVB phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2022to 30 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active or stable non-segmental vitiligo at Screening and Baseline visits:
- A clinical diagnosis of non-segmental vitiligo (vitiligo vulgaris or acrofacial vitiligo) for at least 3 months, AND
- Body Surface Area affected (BSA) involvement 3%-90%, excluding involvement of scalp, palms of the hands, soles of the feet, AND
- BSA >= 0.25% involvement of the facial area, AND
- Minimum Facial Vitiligo Area Scoring Index (F-VASI) >=0.25% and Total VASI >=3%
- Must agree that the treatment area will involve 3%-25% BSA
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- If receiving concomitant medication for any reason other than vitiligo, must be on a stable regimen (no new drug or dosage changes within 7 days of baseline visit) and willing to remain on stable regimen for duration of the study
- Must agree to stop all other treatments for vitiligo from screening through 1 week after discontinuation of study drug treatment
- Must be capable of giving signed informed consent and comply with the requirements and restrictions as listed in the informed consent document and protocol
- Must agree to avoid exposure to the sun as much as possible and not to use tanning booths, sun lamps, or other ultraviolet light sources other than requested by the study team during the study
Who cannot join
- Pregnant or breastfeeding females
- Females of childbearing potential who are unwilling or unable to use contraception for the duration of the study and for at least 28 days after the last dose of study intervention
- Other types of vitiligo that do not meet criteria for active or stable or non-segmental vitiligo, including segmental, mucosal, focal, and mixed vitiligo, and those with vitiligo universalis
- Active forms of other hypo- or depigmentation, as detailed in the protocol
- Active forms of inflammatory skin disease(s) associated with hypo- or depigmentation at the time of screening or baseline that, in the opinion of the investigator, would interfere with evaluation of vitiligo or response to treatment
- Leukotrichia in more than 33% of the facial area affected with vitiligo lesions OR leukotrichia in more than 33% of the total BSA affected with vitiligo lesions
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- History of transplantation procedure for vitiligo at any point
- History of any skin bleaching treatment for vitiligo or other dermatoses at any point
- Active acute or chronic skin infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to first drug application (baseline), OR superficial skin infections within 2 weeks prior to first drug application (NOTE: MAY BE RESCREENED AFTER INFECTION RESOLUTION)
- Known history of severe allergic or anaphylactoid reaction to any PDE4 inhibitors or lidocaine
- Documented lack of response to prior PDE4 inhibitor therapy
- Presence of other severe, progressive, or uncontrolled diseases, including but not limited to renal, hepatic, cardiac, pulmonary, endocrine, immunological/rheumatological, hematological, gastrointestinal, metabolic, neurologic, psychiatric, immunodeficiency (including HIV positive serology), OR significant laboratory abnormalities that would increase risk associated with study participation or interfere with interpretation of study results, or in the opinion of the investigator, the participant is inappropriate for entry into the study, or unwilling/unable to comply with protocol-specified assessments and lifestyle considerations
- Any malignancies or history of skin malignancies, excluding adequately treated or excised non-metastatic basal cell or squamous cell skin cancer, or cervical carcinoma in situ
- Significant trauma or major surgery 1 month prior to screening or considered in imminent need of surgery during the study
- Alcohol or substance abuse within 6 months of screening that in the opinion of the investigator would preclude participation or adherence in the study
- Previous administration of an investigational drug or vaccine occurring within 30 days preceding the first application of study drug used in this study
- Any biologic or immune-modulating agent (including oral JAK inhibitors, PDE4i, other immunosuppressive agents such as oral corticosteroids, calcineurin inhibitors, azathioprine, mycophenolate mofetil) requires a washout period of 8 weeks before screening and through the final safety follow-up visit
- Any topical treatment (such as topical steroids, calcineurin inhibitors, vitamin D analogs, JAK inhibitors, PDE4i) requires a washout period of 2 weeks before screening visit and through the final safety follow-up visit
- Ultraviolet light exposure, including UVB/UVA/PUVA delivered by booth/excimer laser, or tanning bed exposure, requires a washout period of 8 weeks before screening and through the final safety follow-up visit
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz - Clinical and Translational Research Centers
Aurora, Colorado, 80045
About this study
Official title: Study of Efficacy, Safety and Tolerability of Crisaborole and PF-07038124 With and Without NBUVB in Vitiligo: A Phase 2A Randomized, Double-Blind, Vehicle-Controlled Clinical Trial
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crisaborole 2 % Topical OintmentDrug
Also called Eucrisa
Twice daily crisaborole 2% topical ointment
PF-07038124 0.01% topical ointmentDrug
Twice daily PF-07038124 0.01% topical ointment
NBUVB phototherapyDevice
Also called Narrow band UVB
Home narrow band UVB phototherapy exposure sessions 3 times per week
Sham phototherapyDevice
Non-NBUVB visible light radiation exposure sessions 3 times per week
VehicleDrug
Twice daily vehicle ointment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Crisaborole 2 % Topical Ointment; Device: NBUVB phototherapy |
| 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 Receives: Drug: PF-07038124 0.01% topical ointment; Device: NBUVB phototherapy; Drug: Vehicle |
| 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 Receives: Device: NBUVB phototherapy; Drug: Vehicle |
| 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 Receives: Drug: Crisaborole 2 % Topical Ointment; Device: Sham phototherapy |
| Sham phototherapy plus PF-07038124 0.01% topical ointment | Experimental | 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 Receives: Drug: PF-07038124 0.01% topical ointment; Device: Sham phototherapy; Drug: Vehicle |
| Sham phototherapy plus vehicle ointment | Placebo comparator | 8 participants will receive 6 months of sham phototherapy combined with 6 months of vehicle ointment application Receives: Device: Sham phototherapy; Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months (week 24)
Secondary outcomes (4)
Proportion of participants achieving 90% or greater improvement from baseline in F-VASI
Measured: 6 months (week 24)
Proportion of participants achieving 50% or greater improvement from baseline in total (T)-VASI
Measured: 6 months (week 24)
Proportion of participants achieving a Vitiligo Noticeability Scale (VNS) rating of "a lot less noticeable" or "no longer noticeable"
Measured: 6 months (week 24)
Percentage change from baseline in facial segment of Body Surface Area affected (F-BSA)
Measured: 6 months (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start7 Sep 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Stanca Birlea, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298033
- Sponsor's protocol ID
- 21-4837
- Status last verified
- Jun 2024
- First submitted
- 17 Mar 2022
- Last updated
- 12 Jun 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Efficacy, Safety and Tolerability of Crisaborole and PF-07038124 With and Without NBUVB in Vitiligo: A Phase 2A Randomized, Double-Blind, Vehicle-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05298033
- Acronym / sponsor ID
- 21-4837
- Conditions
- Vitiligo
- Keywords
- Vitiligo, PDE-4 inhibitor, Phototherapy, Repigmentation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Active NBUVB plus Crisaborole 2% topical ointment | Experimental | Drug: Crisaborole 2 % Topical Ointment, Device: NBUVB phototherapy12 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 | Drug: PF-07038124 0.01% topical ointment, Device: NBUVB phototherapy, Drug: Vehicle12 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 | Device: NBUVB phototherapy, Drug: Vehicle8 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 | Drug: Crisaborole 2 % Topical Ointment, Device: Sham phototherapy12 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 | Experimental | Drug: PF-07038124 0.01% topical ointment, Device: Sham phototherapy, Drug: Vehicle12 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 | Device: Sham phototherapy, Drug: Vehicle8 participants will receive 6 months of sham phototherapy combined with 6 months of vehicle ointment application |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A clinical diagnosis of non-segmental vitiligo (vitiligo vulgaris or acrofacial vitiligo) for at least 3 months, AND
- Body Surface Area affected (BSA) involvement 3%-90%, excluding involvement of scalp, palms of the hands, soles of the feet, AND
- BSA >= 0.25% involvement of the facial area, AND
- Minimum Facial Vitiligo Area Scoring Index (F-VASI) >=0.25% and Total VASI >=3%
- Must agree that the treatment area will involve 3%-25% BSA
Key exclusion criteria (19 listed)
- Pregnant or breastfeeding females
- Females of childbearing potential who are unwilling or unable to use contraception for the duration of the study and for at least 28 days after the last dose of study intervention
- Other types of vitiligo that do not meet criteria for active or stable or non-segmental vitiligo, including segmental, mucosal, focal, and mixed vitiligo, and those with vitiligo universalis
- Active forms of other hypo- or depigmentation, as detailed in the protocol
- Active forms of inflammatory skin disease(s) associated with hypo- or depigmentation at the time of screening or baseline that, in the opinion of the investigator, would interfere with evaluation of vitiligo or response to treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crisaborole 2 % Topical OintmentAlso: EucrisaTwice daily crisaborole 2% topical ointment | Drug | Active NBUVB plus Crisaborole 2% topical ointment, Sham phototherapy plus crisaborole 2% topical ointment |
| PF-07038124 0.01% topical ointmentTwice daily PF-07038124 0.01% topical ointment | Drug | Active NBUVB plus PF-07038124 0.01% topical ointment, Sham phototherapy plus PF-07038124 0.01% topical ointment |
| NBUVB phototherapyAlso: Narrow band UVBHome narrow band UVB phototherapy exposure sessions 3 times per week | Device | Active NBUVB plus Crisaborole 2% topical ointment, Active NBUVB plus PF-07038124 0.01% topical ointment, Active NBUVB plus vehicle ointment |
| Sham phototherapyNon-NBUVB visible light radiation exposure sessions 3 times per week | Device | Sham phototherapy plus PF-07038124 0.01% topical ointment, Sham phototherapy plus crisaborole 2% topical ointment, Sham phototherapy plus vehicle ointment |
| VehicleTwice daily vehicle ointment | Drug | Active NBUVB plus PF-07038124 0.01% topical ointment, Active NBUVB plus vehicle ointment, Sham phototherapy plus PF-07038124 0.01% topical ointment, Sham phototherapy plus vehicle ointment |
Primary outcome
Proportion of participants achieving at 50% or greater improvement from baseline in facial Vitiligo Area Scoring Index (F)-VASI
Time frame: 6 months (week 24)
Assessment of facial repigmentation via changes in depigmented areas
4 secondary outcomes
Proportion of participants achieving 90% or greater improvement from baseline in F-VASI
Time frame: 6 months (week 24)
Proportion of participants achieving 50% or greater improvement from baseline in total (T)-VASI
Time frame: 6 months (week 24)
Proportion of participants achieving a Vitiligo Noticeability Scale (VNS) rating of "a lot less noticeable" or "no longer noticeable"
Time frame: 6 months (week 24)
Percentage change from baseline in facial segment of Body Surface Area affected (F-BSA)
Time frame: 6 months (24 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanca Birlea, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Crisaborole 2 % Topical Ointment, PF-07038124 0.01% topical ointment and NBUVB phototherapy in people with Vitiligo, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving at 50% or greater improvement from baseline in facial Vitiligo Area Scoring Index (F)-VASI (time frame: 6 months (week 24)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.