A clinical trial to study the effects of two drugs, Tofacitinib 2% w/w ointment and 0.1% hydrocortisone butyrate ointment in patients suffering from dermatitis.
- Conditions
- Health Condition 1: L209- Atopic dermatitis, unspecified
- Registration Number
- CTRI/2022/07/043740
- Lead Sponsor
- yka Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Eligible patients shall be 18â??60 years old with a diagnosis of clinically stable AD (>= 1
month) for >= 6 months prior to the first study dose.
2. Diagnosis of AD performed by a board certified dermatologist using Hanifin and Rajka
criteria at screening/washout.
3. Patients shall have a PGA score of 2 (mild) or 3 (moderate), AD covering 2â??20% of
total BSA and a lichenification score <= 1 in each Eczema Area and Severity Index (EASI)
body region with treatment-eligible AD.
4. AD located on the scalp, palms and soles shall be excluded from the BSA calculation
used to determine eligibility.
5. Patients willing to comply with the protocol requirements.
1. Active forms of other dermatitides/eczematous conditions; evidence of skin conditions that
would interfere with AD evaluation or treatment response.
2. AD on the groin or genitals; evidence of active, latent or inadequately treated
Mycobacterium tuberculosis infection.
3. Hepatitis B/C or HIV infection; history of disseminated or recurrent herpes zoster
infection; infection requiring hospitalization < 6 months prior to the study.
4. Infection requiring oral or topical antimicrobial therapy < 2 weeks prior to the study.
5. History of lymphoproliferative disorders or malignancies (except adequately treated or
excised non-metastatic basal cell or squamous cell skin cancer or cervical carcinoma in
situ) or previous treatment with oral or topical Tofacitinib.
6. Patients shall be excluded who are not able to washout of treatments for AD; specifically,
topical agents for >= 2 weeks prior to day 1, phototherapy or systemic therapy
(immunosuppressive or cytostatic) for >= 16 weeks or corticosteroid therapy (oral or
injectable) for >= 4 weeks prior to screening/washout.
7. Patients who are expected to require such therapy during the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Efficacy End point: <br/ ><br>The percentage changes from baseline in the EASI total score at week 2. <br/ ><br>Time-points: Baseline, Week 1/ Day 07 (±2), week 2/day 14(±2), Unscheduled visit, if <br/ ><br>any.Timepoint: Primary Efficacy End point: <br/ ><br>The percentage changes from baseline in the EASI total score at week 2. <br/ ><br>Time-points: Baseline, Week 1/ Day 07 (±2), week 2/day 14(±2), Unscheduled visit, if <br/ ><br>any.
- Secondary Outcome Measures
Name Time Method