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A study to find the effect of Tofacitinib film forming lotion compared to mometasone solution in baldhead patients

Phase 3
Conditions
Health Condition 1: L639- Alopecia areata, unspecified
Registration Number
CTRI/2024/01/061349
Lead Sponsor
Hetero Healthcare Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Patients aged 18 – 50 years of either gender with clinical diagnosis of alopecia areata.

2. Patients in good health with no evidence of systemic illness.

3. Willing to report response to treatment as per protocol during the study period.

4. Willing to give written informed consent.

Exclusion Criteria

1. Any subject who is currently experiencing significant spontaneous regrowth of terminal hair.

2. Any subject treated with a topical, intralesional or systemic agent likely to cause regrowth in alopecia areata within the past month.

3. Patients who concomitantly using systemic drugs (steroids, cytotoxic agents (methotrexate, azathioprine), vasodilators, antihypertensive agents, anticonvulsant drugs, beta-adrenergic receptor blockers, diuretics, spironolactone, diazoxide, cyclosporine, or ketoconazole.

4. Patients with H / O Tuberculosis or any serious illness.

5. H/ o hypersensitivity to study medication.

6. Participating in other clinical trials

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
- Change in SALT score <br/ ><br>- Percent scalp hair regrowth based on extent of absolute hair loss (percent scalp hair regrowth based on extent of absolute hair loss. (percent scalp hair regrowth based on SALT score).Timepoint: Week 4, week 8 and week 12 (end of study)
Secondary Outcome Measures
NameTimeMethod
Treatment Emergent Adverse Events (TEAEs)Timepoint: Week 4, Week 8 and Week 12
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