A study to compare 0.1 percent Mometasone furoate ointment alone and in combination with 2 percent Tofacitinib in patients of mild to moderate Discoid Lupus Erythematosus

Comparison of efficacy of 0.1 percent Mometasone furoate ointment alone and in combination with 2 percent Tofacitinib ointment in Discoid Lupus Erythematosus - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087853

Enrollment

Registered

2025-05-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L930- Discoid lupus erythematosus

Interventions

Intervention1: 2% Tofacitinib with 0.1% Mometasone furoate ointment: 2% Tofacitinib ointment with 0.1% Mometasone furoate ointment applied locally twice daily on the affected skin for 12 weeks Control

Eligibility

Inclusion criteria

Inclusion criteria: Clinical and dermoscopic diagnosis of Discoid Lupus Erythematosus having Cutaneous Lupus Activity and Severity Index(CLASI Score) of less than or equal to 20 and Cutaneous Lupus Activity Investigator Global Assessment(CLA-IGA) of more than or equal to 2. All the patients should be willing to take part in the study.

Exclusion criteria

Exclusion criteria: 1. Patients less than 18 years of age or not qualifying for the diagnostic criteria. 2. Patients requiring systemic treatment for discoid lupus erythematosus. 3. Unwillingness to give consent or comply with treatment protocol. 4.Diagnosis of Systemic Lupus Erythematosus. 5. Diagnosis of overlap syndrome, mixed connective tissue disease, drug-induced Cutaneous Lupus or other dermatological disease hindering assessment. 6. Major medical illness. 7. Patients on UV therapy. 8. Pregnant or breastfeeding women.

Design outcomes

Primary

Measure	Time frame
Mean number of Discoid Lupus Erythematosus Patients achieving 4-point or 20% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index(CLASI) scoreTimepoint: Baseline, 4 weeks, 8 weeks and 12 weeks	—

Secondary

Measure	Time frame
Comparison of changes in dermoscopic features with treatmentTimepoint: Baseline, 4 weeks, 8 weeks,12 weeks;Percentage of patients achieving Cutaneous Lupus Activity Investigators Global Assessment(CLA-IGA) of 0 or 1.Timepoint: Baseline, 4 weeks, 8 weeks,12 weeks;Change in JAK-STAT expression, Neutrophils & B-1 cells expression in the skin tissue of both the treatment groupsTimepoint: Baseline & 12 weeks;Change in expression of S100A9, G-CSF, Seglac G, & CXCL-10 in skin tissue samples of both the treatment groups.Timepoint: Baseline & 12 weeks	—

Measure

Time frame

Comparison of changes in dermoscopic features with treatmentTimepoint: Baseline, 4 weeks, 8 weeks,12 weeks;Percentage of patients achieving Cutaneous Lupus Activity Investigators Global Assessment(CLA-IGA) of 0 or 1.Timepoint: Baseline, 4 weeks, 8 weeks,12 weeks;Change in JAK-STAT expression, Neutrophils & B-1 cells expression in the skin tissue of both the treatment groupsTimepoint: Baseline & 12 weeks;Change in expression of S100A9, G-CSF, Seglac G, & CXCL-10 in skin tissue samples of both the treatment groups.Timepoint: Baseline & 12 weeks

—

Countries

India

Contacts

Public ContactPratibha Singh

Postgraduate Institute of Medical Education and Research

vinsh777@gmail.com9599479980

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026