Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: Tofacitinib Lotion 2% w/v: Patients will be advised to apply a thin layer of the study drug twice daily (approximately 12±3 hours apart) to all atopic dermatitis affected areas, except
Sponsors
Precise Biopharma Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 18 to 60 years (both inclusive). 2. Patients with a clinical diagnosis of atopic dermatitis (also known as atopic eczema confirmed to be atopic dermatitis according to the criteria of Hanifin and Rajka) at screening visit. 3. Patients with mild to moderate atopic dermatitis based on Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 2 (mild) or 3 (moderate) at baseline visit. 4. Patients with atopic dermatitis area involvement =5% treatable body surface area (BSA) (excluding the scalp) and up to and including 20% of total body surface area at baseline visit. 5. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening / baseline visit. 6. Patients with ability to fully understand and provide written, signed and dated informed consent form, which must have been obtained prior to screening visit. 7. Patients willing to comply with all the protocol related requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with unstable atopic dermatitis or a history of requirement for high / strong potency or very high / very strong potency topical or oral corticosteroids to manage atopic dermatitis signs and symptoms. 2. Patients with a history of or currently experiencing other concomitant skin conditions like lupus erythematosus, psoriasis or mycosis fungoides that requires frequent hospitalizations and/or continued treatment for skin infections. 3. Patients with clinically significant medical disorder, condition, or disease (including active or potentially recurrent non-atopic dermatitis dermatological conditions and known genetic dermatological conditions that overlap with atopic dermatitis, such as Netherton syndrome) or clinically significant physical examination finding at screening that may interfere with study objectives / safety of participants. 4. Patients with a significant active systemic or localized infection, including known actively infected atopic dermatitis. 5. Patients with a history of eczema herpeticum within 12 months, and/or a history of 2 or more episodes of eczema herpeticum in the past. 6. Patients with clinically significant uncontrolled systemic diseases such as gastrointestinal, cardiovascular, renal, neurological, psychiatric, endocrine or hematological disorders or malignancy. 7. Patients with a history of immunocompromised status. 8. Patients with a history of disseminated or recurrent herpes zoster infection. 9. Patients with currently experiencing a skin infection or any other infection that requires treatment, or is currently being treated, with topical or systemic antibiotics. 10. Patients with known case of tuberculosis infection or history of incompletely treated or untreated tuberculosis. 11. Patients who are already treated with phototherapy, systemic immunosuppressants, cytostatic drugs, systemic corticosteroid, oral Janus kinase (JAK) inhibitor, monoclonal antibody, leukotriene antagonist, systemic antibiotics, or herbal medications with unknown properties or known beneficial effects for atopic dermatitis within 1 month prior to randomization. 12. Patients with topical therapy (corticosteroids, tars, antihistamines, antibiotic creams, phosphodiesterase 4 [PDE4] inhibitors, retinoids or benzoyl peroxide products [BPO], antibacterial medications or antibacterial products included in soaps, bleach baths, or topical sodium hypochlorite-based products) within 14 days prior to randomization. 13. Patients with the use of other investigational products for the treatment of atopic dermatitis within 2 months prior to randomization. 14. Patients with known hypersensitivity or allergic to Tofacitinib or any macrolide or Pimecrolimus or any excipients of the study drug. 15. Female patients who are pregnant or breast-feeding or expecting to conceive within the projected duration of the study. 16. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device). 17. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent / assent. 18. Patients with known case of infection with hepatitis B, hepatitis C or HIV. 19. Patients with hepatic dysfunction (SGOT & SGPT = 3 X Upper N
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in Eczema Area and Severity Index (EASI) total score from baseline to end of the study visit (week 4).Timepoint: At Baseline / Day 1 and Week 4 / Day 29 (±1). | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and/or serious adverse events reported during the study.Timepoint: Throughout the study.;Change from baseline in body surface area (BSA) affected at end of week 2 and week 4.Timepoint: At Baseline / Day 1, Week 2 / Day 14 (±1) and Week 4 / Day 29 (±1).;Change from baseline patient’s assessment of pruritus using numeric scale at end of week 2 and week 4.Timepoint: At Baseline / Day 1, Week 2 / Day 14 (±1) and Week 4 / Day 29 (±1).;Changes in clinical laboratory parameters from screening to end of the study visit (Week 4).Timepoint: At Baseline / Day 1 and Week 4 / Day 29 (±1).;Local tolerability during the study.Timepoint: Throughout the study.;Percentage of patients achieving Eczema Area and Severity Index response of morethan or equal to 50 percent (%) improvement (EASI-50) from baseline at end of week 2 and week 4.Timepoint: At Baseline / Day 1, Week 2 / Day 14 (±1) and Week 4 / Day 29 (±1).;Percentage of patients achieving Eczema Area and Severity Index response of morethan or equal to 75 percent (%) improvement (EASI-75) from baseline at end of week 2 and week 4.Timepoint: At Baseline / Day 1, Week 2 / Day 14 (±1) and Week 4 / Day 29 (±1).;Percentage of patients achieving Eczema Area and Severity Index response of morethan or equal to 90 percent (%) improvement (EASI-90) from baseline at end of week 2 and week 4.Timepoint: At Baseline / Day 1, Week 2 / Day 14 (±1) and Week 4 / Day 29 (±1).;Percentage of patients achieving Investigators Global Assessment (IGA) score of “0 ? or “1 ? with a 2 point improvement at end of week 2 and week 4.Timepoint: At Week 2 / Day 14 (±1) and Week 4 / Day 29 (±1). | — |
Countries
India
Contacts
Public ContactMr Vipen Seth
Clinwave Research Pvt. Ltd.
Outcome results
None listed