Health Condition 1: L20- Atopic dermatitis
Conditions
Interventions
Intervention1: Ruxolitinib 1.5 % Cream: A thin layer of the intervention product will be applied twice daily to affected area(s) for 8 weeks.
Control Intervention1: Tofacitinib 2 % Ointment: A thin la
Sponsors
Torrent Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants of 18-65 years of age. 2. Diagnosed with Atopic Dermatitis (AD) as defined by the Hanifin and Rajka criteria 3. Diagnosis of AD and a history of AD greater than or equal to 3 months prior to baseline. 4. AD involvement of greater than or equal to 3% to less than or equal to 20% BSA (excluding scalp) at baseline. 5. IGA score of 2 (mild) or 3 (moderate) at screening and baseline. 6. Willing to avoid use of other AD medications other than study medication including OTC, herbal, home remedies during study. 7. Documented/verbal report of inadequate response or intolerance to medicated topical therapy for AD within past 1 year. 8. Willing to give written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Unstable AD course in the 4 weeks prior to baseline. 2. Participants with known allergies or hypersensitivity to study interventions, components, excipients, or any other allergy. 3. Participants with concurrent conditions and history of other diseases: a. Immunocompromised. b. Acute or chronic systemic infection requiring treatment within 2 weeks, or recurrent systemic infection within 6 months prior to screening. c. Active acute bacterial, fungal, or viral skin infection within 1 week before screening. d. Serious infection requiring hospitalization or IV anti infectives within 4 weeks. e. Other skin disorders, sunburn, pigmentation changes, or extensive scarring that may interfere with AD evaluation or safety. f. AD lesions limited to hands or feet without prior classical involvement (face or folds). g. History of confounding skin conditions (psoriasis, rosacea, erythroderma, or ichthyosis or other types of eczema. 4. Serious medical or psychiatric illness interfering with study participation. 5. Participants using any of the following treatments within washout period before baseline: a. 5 Half-lives or 12 weeks, whichever is longer-Biologics for AD. b. 4 weeks- Oral or IV corticosteroid, UVA or UVB, PUVA, tanning booths, sun lamps or nonprescription UV light, systemic immunomodulators or immunosuppressants, interferon, cytotoxic drugs, tacrolimus (systemic), or allergen immunotherapy. c. 14 Days- Systemic antibiotics or antifungal, calcipotriene or other topical vitamin D preparations or retinoids. d. 7 Days- Antihistaminics, topical antibiotics or antifungal, topical corticosteroids, coal tar shampoo, antibacterial body wash or soap, other topical treatments for AD including PDE4-inhibitors, tacrolimus or pimecrolimus (topical), aryl hydrocarbon receptor agonist. e. 24 Hours- Any topical product other than the assigned treatment (sunscreen, cosmetics, lotion, ointment, powder, or emollient) applied on or near the treatment area. f. Not willing to minimize or avoid natural or artificial sunlight exposure during treatment. g. Use of CYP3A4 inhibitors or inducers or CYP2C19 inhibitors within 5 half lives before the first dose of study intervention. h. Live or live-attenuated vaccination during the study. 6. Prior JAK inhibitor use within 3 months. 7. History of active pulmonary or extra-pulmonary TB within 1 year prior to screening or positive QuantiFERON-TB Gold test at screening. 8. History of invasive fungal infection (including cryptococcosis and pneumocystosis) or any other opportunistic infection or immunocompromised disorder or condition. 9. Patients with HIV-positive, Hepatitis-B & C-positive. 10. Abnormal Liver function tests (AST or ALT greater than or equal to 2 ULN, ALP & or total bilirubin greater than 1.5 ULN) 11. Hemoglobin less than 10 g per dL at screening 12. Pregnant or lactating women, or those considering pregnancy or females of childbearing potential, who are neither surgically sterilized nor willing to use reliable contraceptive methods throughout the study duration. 13. Male participants of childbearing potential not willing to use reliable contraception methods throughout the study duration. 14. eGFR less than 30 ml/min/1.73 m2 as per MDRD formula. 15. Participation in another clinical trial with
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with treatment success based on IGA of Disease Severity.Timepoint: Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with treatment success based on IGA of Disease Severity.Timepoint: Week 2 & Week 4;Change from baseline in the total score of EASI.Timepoint: Week 2, Week 4 & Week 8;Proportion of participants who achieve EASI50.Timepoint: Week 2, Week 4 & Week 8;Proportion of participants who achieve EASI75.Timepoint: Week 2, Week 4 & Week 8;Proportion of participants who achieve EASI90.Timepoint: Week 2, Week 4 & Week 8;Mean percentage change from baseline in SCORAD score.Timepoint: Week 2, Week 4 & Week 8;Percent BSA involvement.Timepoint: Week 0, Week 2, Week 4 & Week 8;Change from baseline in Itch NRS scoreTimepoint: Week 0, Week 1, Week 2, Week 4 & Week 8;Incidence of treatment emergent adverse events.Timepoint: Throughout the Study;Application site reaction.Timepoint: Throughout the Study | — |
Countries
India
Contacts
Public ContactDr Prashant Jamadarkhana
Torrent Pharmaceuticals Limited
Outcome results
None listed