Vitiligo Clinical Trial
Official title:
A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Mechanism of Action of Ruxolitinib Cream for Vitiligo
Verified date | April 2024 |
Source | Incyte Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 10, 2023 |
Est. primary completion date | November 17, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria - A clinical diagnosis of nonsegmental vitiligo with depigmented areas including = 0.5% BSA on the face, = 0.5 F-VASI, = 3% BSA on nonfacial areas, and = 3 T-VASI; total body vitiligo area (facial and nonfacial) should not exceed 50% BSA. - At least 1 active vitiligo lesion (eg, such as confetti lesion, trichrome appearance, pinkish rim, or other evidence of inflammatory activity) at the site for skin biopsy. - Agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted. Exclusion Criteria - No pigmented hair within any of the vitiligo areas on the face. - Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor). - Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas except hydroquinone. - Any other skin disease that, in the opinion of the investigator, would interfere with the study medication application or study assessments. - Conditions at baseline that would interfere with evaluation of vitiligo. - Use of any protocol-defined treatments within the indicated washout period before baseline. |
Country | Name | City | State |
---|---|---|---|
Canada | Simcoderm Medical and Surgical Dermatology Center | Barrie | Ontario |
Canada | Dermatology Research Institute | Calgary | Alberta |
Canada | Lynderm Research Inc | Markham | Ontario |
Canada | JRB Research Inc | Ottawa | Ontario |
France | Hopital Saint Andre | Bordeaux | |
France | Centre Hospitalier Universitaire Henri Mondor | Creteil | |
France | Hopital Archet 2 Derm Dept | Nice | |
United States | Suny Downstate Medical Center | Brooklyn | New York |
United States | First Oc Dermatology | Fountain Valley | California |
United States | UC Irvine | Irvine | California |
United States | Mount Sinai Hospital | New York | New York |
United States | Dermatology Specialists of Spokane | Spokane | Washington |
United States | George Washington Medical Faculty Associates | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Incyte Corporation |
United States, Canada, France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24 | Baseline was defined as the last non-missing measurement obtained on or before the first application of study drug. Percentage change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value)*100. | Baseline; Week 4, Week 12, and Week 24 | |
Secondary | Correlation of Key Skin Inflammatory Biomarkers of Vitiligo in Target Lesions to Efficacy Readouts | Clinical scores (facial Vitiligo Area Scoring Index [F-VASI] and total body Vitiligo Area Scoring Index [T-VASI]) were evaluated for correlation with skin CXCL10 levels. | Baseline, Week 12, and Week 24 | |
Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. | from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days) | |
Secondary | Number of Participants With TEAEs During the Treatment-Extension Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. | from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 days | |
Secondary | Number of Participants With a Grade 3 or Higher TEAE During the Double-Blind Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. AE severity was assessed per the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated; Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living; Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4: life-threatening consequences; urgent treatment indicated; Grade 5: fatal. | from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days) | |
Secondary | Number of Participants With a Grade 3 or Higher TEAE During the Treatment-Extension Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. AE severity was assessed per the CTCAE, version 5.0: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated; Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living; Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4: life-threatening consequences; urgent treatment indicated; Grade 5: fatal. | from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 days |
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