Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05787860
Other study ID # GCO 22-0672
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 15, 2022
Est. completion date January 26, 2024

Study information

Verified date March 2024
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is an open-label prospective interventional trial that will assess the efficacy of ruxolitinib in the treatment of seborrheic dermatitis. It will also attempt to characterize the molecular immune profiles of patients with SD at week 0 and week 4, with comparison to baseline profiles in healthy control subjects.


Description:

The study will include 25 adult patients with moderate-to-severe-SD as well as 20 age- and gender-matched healthy control subjects for comparison. The SD patients will have baseline clinical score of at least 6 using the SD Severity Score in Appendix 1, or an Investigator Global Assessment (IGA) score of at least 3. Enrolled SD subjects will apply topical ruxolitinib 1.5% cream twice daily for 4 weeks. They will return for visits at weeks 2, 4, and 6 following study treatment initiation for repeat clinical assessments, medication reviews, tape-strip, blood and urine sample collections, and monitoring for adverse events.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date January 26, 2024
Est. primary completion date January 26, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria For SD Subjects: - Male or female subjects = 18 years of age at the time of signing the informed consent document. - Subject is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures. - Subject is able to adhere to the study visit schedule and other protocol requirements. - Baseline SD score of IGA = 3 with facial involvement - Subject agrees to discontinue all treatments for SD from screening through study completion aside from the study drug - Subject has failed an adequate course of treatment with at least one available therapy (topical antifungals or low-potency topical corticosteroids) - Subject is judged to be in otherwise good overall health as judged by the investigator, based on medical history, physical examination, and laboratory testing. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions). - Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on the study drug and for at least 90 days after the last application of the study drug, male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below: - Option 1: Any one of the following highly effective contraceptive methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy, OR: - Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]); PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide. The female subject's chosen form of contraception must be effective by the time the female subject is enrolled into the study. Inclusion Criteria For Control Subjects: - Male or female subjects = 18 years of age at the time of signing the informed consent document. - Subject is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures. - Subject does not currently have and does not have a history of SD. - Female of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline Exclusion Criteria For SD Subjects: The presence of any of the following will exclude a subject from enrollment: - SD clinical severity of IGA <3 and SD Severity Score <6. - Subjects with other skin diseases that would interfere with the study assessment in the opinion of the investigator. - Active bacterial, fungal, or viral skin infection within 2 weeks from study initiation. - Subject has clinically significant (as determined by the investigator) renal, hepatic, hematologic, intestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric, immunologic, or other major uncontrolled diseases (e.g., malignancy, TB, HIV, HBV, HCV, thromboembolic events) that will affect the health of the subject during the study, or interfere with the interpretation of study results. - Subject has previously received treatment with oral or topical JAK inhibitors - Current other topical treatments (e.g., topical corticosteroids, topical calcineurin inhibitors) within 1 week of baseline - Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus within 4 weeks of study initiation - Concurrent use of strong CYP3A4 inhibitors within 7 days or 5 half-lives (whichever is longer). A list of CYP3A4 inhibiting medications can be found in Appendix 3. - History of adverse systemic or allergic reactions to any component of the study drug. - Current participation in any other study with an investigational medication - Subject who is pregnant or breast feeding Exclusion Criteria For Control Subjects: - Active bacterial, fungal, or viral skin infection within 2 weeks from Screening/Baseline visit. - Subject has uncontrolled clinically significant (as determined by the investigator) renal, hepatic, hematologic, intestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric, immunologic, or other disease. - Subject has previously received treatment with oral or topical JAK inhibitors - Current other topical treatments (e.g., topical corticosteroids, topical calcineurin inhibitors) within 1 week of baseline - Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus within 4 weeks of study initiation - Current participation in any other study with an investigational medication - Subject who is pregnant or breast feeding

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ruxolitinib 1.5% Cream
topical ruxolitinib 1.5% cream twice daily for 4 weeks

Locations

Country Name City State
United States Icahn School of Medicine at Mount Sinai New York New York

Sponsors (2)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Investigator Global Assessment of 0 or 1 at Week 4 IGA Scale from 0-4
Clear 0 No signs of SD
Almost Clear 1 Just perceptible erythema and just perceptible scaling
Mild 2 Mild erythema and mild scaling
Moderate 3 Moderate erythema and moderate scaling
Severe 4 Severe erythema and severe scaling
At end of Treatment, Week 4
Secondary Change in Investigator Global Assessment from baseline to week 4 IGA Scale from 0-4
Clear 0 No signs of SD
Almost Clear 1 Just perceptible erythema and just perceptible scaling
Mild 2 Mild erythema and mild scaling
Moderate 3 Moderate erythema and moderate scaling
Severe 4 Severe erythema and severe scaling
Baseline and Week 4
Secondary Change in seborrheic dermatitis severity score from baseline to week 4 SD Severity Score (the sum of the three clinical features for a total score ranging from 0-12), where higher scores indicate more severe outcomes.
Scale 0-4 Erythema 0-4 Pruritus 0-4 (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)
Baseline and Week 4
Secondary Change in seborrheic dermatitis severity score for Scale from baseline to week 4 Scale 0-4, where higher scores indicate more severe outcomes.
(0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)
Baseline and Week 4
Secondary Change in seborrheic dermatitis severity score for Erythema from baseline to week 4 Erythema 0-4, where higher scores indicate more severe outcomes.
(0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)
Baseline and Week 4
Secondary Change in seborrheic dermatitis severity score for Pruritus from baseline to week 4 Pruritus 0-4, where higher scores indicate more severe outcomes.
(0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)
Baseline and Week 4
Secondary Change in seborrheic dermatitis severity score from baseline to week 6 SD Severity Score (the sum of the three clinical features for a total score ranging from 0-12), where higher scores indicate more severe outcomes.
Scale 0-4 Erythema 0-4 Pruritus 0-4 (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)
Baseline to Week 6
Secondary Change in seborrheic dermatitis severity score from week 4 to week 6 SD Severity Score (the sum of the three clinical features for a total score ranging from 0-12), where higher scores indicate more severe outcomes.
Scale 0-4 Erythema 0-4 Pruritus 0-4 (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)
Week 4 and Week 6
Secondary Frequency of Adverse Events Baseline to Week 6
Secondary Duration of Adverse Events Baseline to Week 6
Secondary Severity of Adverse Events Severity will be measured as a category (mild, moderate, or severe). Baseline to Week 6
See also
  Status Clinical Trial Phase
Completed NCT01703793 - Safety and Efficacy Study in Subjects With Seborrheic Dermatitis Phase 2
Completed NCT01203189 - Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo N/A
Completed NCT00991198 - The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage Phase 2
Completed NCT03567980 - A Proof of Concept Clinical Trial Evaluating the Safety and Efficacy of Eucrisa (Crisaborole) in Patients With Seborrheic Dermatitis Phase 4
Recruiting NCT03688971 - Omiganan Twice a Day (BID) in Patients With Facial Seborrheic Dermatitis Phase 2
Recruiting NCT01139749 - Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea Phase 4
Completed NCT05105139 - Study to Evaluate the Safety of Sebryl® and Sebryl Plus® in Seborrheic Dermatitis and Psoriasis of Scalp
Completed NCT01591070 - Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis Phase 4
Completed NCT00403559 - A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis Phase 2
Not yet recruiting NCT00767546 - Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients Phase 1
Terminated NCT01315951 - Petrolatum's Effect on Initial Symptoms of Nonscalp Seborrheic Dermatitis and Preventing Exacerbation N/A
Recruiting NCT05942248 - The Use of Image-Based Computer Gradings in the Analysis of Acne, Rosacea, Melasma, and Seborrheic Dermatitis N/A
Recruiting NCT06013371 - PDE4 Inhibition in Seborrheic Dermatitis and Papulopustular Rosacea Phase 2
Recruiting NCT05319444 - Cleansing Device for the Treatment of Scalp and Hair Conditions N/A
Completed NCT04445987 - Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis Phase 2
Completed NCT04973228 - Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM) Phase 3
Completed NCT03114111 - Pilot Study for the Use of Photodynamic Therapy in the Treatment of Seborrheic Dermatitis Early Phase 1
Completed NCT02656368 - Safety and Efficacy of SEBORRHEAMEDIS Face Cream in Patients With Seborrheic Dermatitis N/A
Completed NCT00830908 - HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis N/A
Completed NCT02349854 - Neurobiology of the Scalp in Seborrheic Dermatitis N/A