A clinical study to assess the efficacy and safety of Tofacitinib Lotion 2% w/v in dermatitis patients.
- Conditions
- Health Condition 1: L209- Atopic dermatitis, unspecified
- Registration Number
- CTRI/2023/12/060924
- Lead Sponsor
- Precise Biopharma Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 184
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br>Week 4 / Day 29 (±1).
- Secondary Outcome Measures
Name Time Method