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.

Phase 3

Not yet recruiting

• Conditions: Atopic dermatitis, unspecified,

• Registration Number: CTRI/2022/07/043740
• Lead Sponsor: Lyka Labs Limited

Brief Summary

This trial is aphase III, randomized, comparative, Active-Controlled, parallel group,multicenter clinical study to evaluate the efficacy, safety and tolerability of

1.           Tofacitinib ointment 2% w/w versus

2.           0.1% hydrocortisone butyrate ointmentapproved by the office of DCGI

in patients withMild to Moderate Atopic Dermatitis

Patients who arewilling and able to participate in the study will sign and date the InformedConsent Form on the day of screening / baseline visit (Visit 1). During thisscreening period, patients who are willing to give consent will be evaluatedfor all the eligibility criteria. Eligible patients (male or female) agedbetween 18 to 65 years (both inclusive), Patients will be assigned to either ofthe TWO arms i.e. as mentioned above. Patients will be given the studymedication Tofacitinib ointment or 0.1% hydrocortisone butyrate ointment for 2weeks. After confirming the inclusion/exclusion criteria the subject will berandomized and provided with study medication at randomization visit. Subjectswill be provided with diary at randomization visit, which need to be broughtalong with in each subsequent visit till the last visit. Follow up visits willbe done on Week 1/ Day 07 (±2), week 2/day AND 14(±2) days of treatment toassess efficacy, safety and tolerability.

Primary EfficacyEnd point: The percentage changes from baseline in the EASI total score at week2. Time-points: Baseline, Week 1/ Day 07 (±2), week 2/day 14(±2), Unscheduledvisit, if any.

Safetyassessment includes Treatment Emergent Adverse Events (TEAEs) assessment duringthe study.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-07
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Eligible patients shall be 18–60 years old with a diagnosis of clinically stable AD (≥ 1 month) for ≥ 6 months prior to the first study dose.
• Diagnosis of AD performed by a board certified dermatologist using Hanifin and Rajka criteria at screening/washout.
• Patients shall have a PGA score of 2 (mild) or 3 (moderate), AD covering 2–20% of total BSA and a lichenification score ≤ 1 in each Eczema Area and Severity Index (EASI) body region with treatment-eligible AD.
• AD located on the scalp, palms and soles shall be excluded from the BSA calculation used to determine eligibility.
• Patients willing to comply with the protocol requirements.

Exclusion Criteria

• Active forms of other dermatitides/eczematous conditions; evidence of skin conditions that would interfere with AD evaluation or treatment response.
• AD on the groin or genitals; evidence of active, latent or inadequately treated Mycobacterium tuberculosis infection.
• Hepatitis B/C or HIV infection; history of disseminated or recurrent herpes zoster infection; infection requiring hospitalization < 6 months prior to the study.
• Infection requiring oral or topical antimicrobial therapy < 2 weeks prior to the study.
• 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.
• 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.
• 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:	Primary Efficacy End point: | The percentage changes from baseline in the EASI total score at week 2. | Time-points: Baseline, Week 1/ Day 07 (±2), week 2/day 14(±2), Unscheduled visit, if | any.
The percentage changes from baseline in the EASI total score at week 2.	Primary Efficacy End point: | The percentage changes from baseline in the EASI total score at week 2. | Time-points: Baseline, Week 1/ Day 07 (±2), week 2/day 14(±2), Unscheduled visit, if | any.
Time-points: Baseline, Week 1/ Day 07 (±2), week 2/day 14(±2), Unscheduled visit, if	Primary Efficacy End point: | The percentage changes from baseline in the EASI total score at week 2. | Time-points: Baseline, Week 1/ Day 07 (±2), week 2/day 14(±2), Unscheduled visit, if | any.
any.	Primary Efficacy End point: | The percentage changes from baseline in the EASI total score at week 2. | Time-points: Baseline, Week 1/ Day 07 (±2), week 2/day 14(±2), Unscheduled visit, if | any.

Secondary Outcome Measures

Name	Time	Method
Secondary Efficacy End point:	ï‚· Secondary efficacy end points measured at weeks 1 and 2 including the proportion

Trial Locations

Locations (6)

Apple Skin and Hair Clinic; 🇮🇳 Amravati, MAHARASHTRA, India

Charak Hospital and Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

Cutis Institute of Dermatology, Srinagar; 🇮🇳 JAMMU, & KASHMIR, India

GCS Medical College Hospital and Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Hope well Medical Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Shubham Sadbhawana Super Specialty Hospital; 🇮🇳 Varanasi, UTTAR PRADESH, India

Apple Skin and Hair Clinic

🇮🇳Amravati, MAHARASHTRA, India

Dr Yogesh Zanwar

Principal investigator

91-9823072240

appleskinandhair@gmail.com