Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to investigate the use of topical tofacitinib to promote hair regrowth in patients with alopecia areata, alopecia totalis, and alopecia universalis.
This will be an open label clinical trial. We plan to treat 10 adults with AA (with at least 2 patches of alopecia involving the scalp), AT or AU with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth. Laboratory evaluation will be performed before and during treatment in order to monitor for adverse effects of the medication.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tofacitinib ointment | Experimental | Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib ointment | Drug | Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Severity of Alopecia Tool (SALT) Score | SALT score range is from 0 (no hair loss) to 100 (100% hair loss). A positive percent change from baseline corresponds to a reduction in SALT score, and in this study study will be measured between baseline and 6 months. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Response Assessed as the Number of Participants With Hair Regrowth | Clinical photographs will be used to demonstrate presence or absence of hair regrowth. Presented is a count of people that did respond to treatment. | 6 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brett King, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale-New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28619556 | Derived | Bayart CB, DeNiro KL, Brichta L, Craiglow BG, Sidbury R. Topical Janus kinase inhibitors for the treatment of pediatric alopecia areata. J Am Acad Dermatol. 2017 Jul;77(1):167-170. doi: 10.1016/j.jaad.2017.03.024. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tofacitinib Ointment | Patients with alopecia areata (AA) (with at least 2 patches of alopecia involving the scalp), alopecia totalis (AT) or alopecia universalis (AU) will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth between baseline and the end of study. Tofacitinib ointment: Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth between baseline and end of study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tofacitinib Ointment | Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth. Tofacitinib ointment: Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Severity of Alopecia Tool (SALT) Score | SALT score range is from 0 (no hair loss) to 100 (100% hair loss). A positive percent change from baseline corresponds to a reduction in SALT score, and in this study study will be measured between baseline and 6 months. | Posted | Mean | Full Range | percent change | 6 Months |
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tofacitinib Ointment | Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth. Tofacitinib ointment: Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett King, MD, PhD, BA, Associate Professor of Dermatology | Yale Dermatology - Middlebury | (203) 737-4825 | brett.king@yale.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2016 | Sep 12, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| C537055 | Alopecia universalis |
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| SALT score | SALT score range is from 0 (no hair loss) to 100 (100% hair loss) | Mean | Standard Deviation | units on a scale |
|
|
|
| Secondary | Treatment Response Assessed as the Number of Participants With Hair Regrowth | Clinical photographs will be used to demonstrate presence or absence of hair regrowth. Presented is a count of people that did respond to treatment. | Posted | Count of Participants | Participants | 6 Months |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 7 |
| 10 |
| Sinus Infection | Infections and infestations | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Folliculitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Scalp Skin Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |