Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: Ruxolitinib 1.5% Cream,: twice daily to affected areas (3 to 20% body surface area) for 8 Weeks
Control Intervention1: Pimecrolimus 1% Cream: twice daily to affected areas (3 to 20% bod
Sponsors
Sun Pharmaceutical Industries Limited (SPIL)
Sun Pharmaceutical Industries Limited SPIL
Eligibility
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be eligible to participate in the study: 1.Patients of either gender with age between 18 to 65 years (both inclusive) and willing to provide written informed consent 2.Non-immunocompromised patients with a clinical diagnosis of AD 3.Patients having Eczema Area and Severity Index (EASI) Score of 1.1 - 21.0 at screening and randomization visit 4.An Investigator s Global Assessment (IGA) of disease severity of mild (Score 2) or moderate (Score 3) at screening and randomization visits 5.Documented recent history (within 3 months before the screening visit) of inadequate response to treatment with topical medications 6.Affected area of AD involvement of 3 to 20% Body Surface Area (BSA) (excluding scalp) 7.Patients who agree to discontinue all agents used to treat AD from the screening visit through the final safety follow-up. 8.Women of childbearing potential must have a negative urine pregnancy test at Screening and Randomization and agree to use highly effective methods of contraception to prevent pregnancy from study entry till EOS (such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence OR non-hormonal contraception [e.g. condoms with spermicide]) [Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Postmenopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age] Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners should be practicing highly effective contraception throughout the study period. (Contraception by female partner is not required if she is not a woman of childbearing potential) [No sperm donation is allowed during the study period]
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from participation in the study: 1. Active cutaneous bacterial or viral infection 2. Other types of eczemas 3. An unstable course of AD 4. History of confounding skin conditions (e.g., psoriasis, rosacea, erythroderma, or ichthyosis) 5. Patients having significant renal or hepatic impairment ( 6. History or presence of immunological deficiencies or diseases, clinically significant or uncontrolled cardiovascular disease or diabetes, malignancy, serious active or recurrent infection, neuropsychiatry disorders, genetic diseases or any other condition that in the Investigator s opinion may put the subject at increased risk 7. Patients with a history of disseminated or recurrent herpes zoster infection 8. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the screening visit 9. Use within 4 weeks prior to Baseline of prohibited medications 10. Use of other Investigational products used for the treatment of AD within 3 months prior to Baseline 11. Patient with history or positive result of human immunodeficiency virus (HIV) and/or hepatitis B virus (HbsAg) and/or hepatitis C virus (HCV) at screening. 12. Women who are pregnant, nursing, or fertile and not willing to use contraception during the study period 13. Hypersensitivity to study medications or to any of their excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Ruxolitinib Cream in comparison to Pimecrolimus Cream.Timepoint: Timeframe: Baseline, Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: To evaluate the efficacy of Ruxolitinib Cream in comparison to Pimecrolimus Cream further on additional efficacy endpoints. Safety To evaluate the safety and tolerability of Ruxolitinib Cream in comparison to Pimecrolimus Cream. Timepoint: study | — |
Countries
India
Contacts
Public ContactDr Rajiv Yadav
Sun Pharma Laboratories Limited
Outcome results
None listed