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Efficacy and safety evaluation of Rhofanib® (Tofacitinib) in the treatment of lichen planopilaris

Compression of the Efficacy and safety of Rhofanib® (Tofacitinib) with placebo in the symptom control and improvement of hair loss in patients with lichen planopilaris

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200107046041N2
Enrollment
48
Registered
2020-08-21
Start date
2020-08-22
Completion date
Unknown
Last updated
2020-09-07

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

Conditions

lichen planopilaris. Lichen planopilaris

Interventions

Intervention 1: Intervention group: this group receives Rhofanib (Tofacitinib) 5mg twice a day with concurrent topical clobetasol for 6 months and then will be followed for 3 months after cessation of

Sponsors

Nanoalvand Co.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Signing informed consent form Biopsy confirmed lichen planopilaris Age between 18-55 LPPAI>5 Women with reproductive potential who had accepted to use effective contraception during the study period

Exclusion criteria

Exclusion criteria: More than 20% scalp involvement Concurrent alopecia areata Current malignancies History of malignancies in the past 5 years Active infection Pregnancy and lactation Use of systemic drugs such as systemic corticosteroids, cyclosporine, hydroxychloroquine, mycophenolate mofetil in the past 3 months Hypersensitivity to tofacitinib or any components of its formulation Latent TB Hepatitis B and/or C infections Bone marrow suppression (Hb<9g/dl, ANC<1000 cells/mm3, Lymphocyte<500 cells/mm3)

Design outcomes

Primary

MeasureTime frame
Lichen Planopilaris Activity Index (LPPAI). Timepoint: Baseline, months 1, 3, 6 and 9. Method of measurement: Lichen Planopilaris Activity Index (LPPAI): Pruritus Pain Burning Erythema Perifullic erythema Perifollicular scale Pull test: anagen/ total Spreading.

Secondary

MeasureTime frame
Patients quality of life. Timepoint: Baseline, months 1, 3, 6 and 9. Method of measurement: Dermatology quality of life questionnaire.;Adverse events. Timepoint: Baseline, months 1, 3, 6 and 9. Method of measurement: Patients self report, physicians observation and lab test abnormalities.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamideh Morravej Farshi

Shahid Beheshti University of Medical Sciences

hamidehmoravej@sbmu.ac.ir+98 21 2274 1507

Outcome results

None listed

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