Alopecia Skin and Connective Tissue Diseases
Conditions
Interventions
This is a randomized, controlled, triple-blind, single-center, two-arm parallel clinical trial involving 50 participants with frontal fibrosing alopecia and inflammatory signs. Participants will be ra
Sponsors
Hospital Universitario Pedro Ernesto
Hospital Universitario Pedro Ernesto
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants of both sexes; age 18 years or older; clinical diagnosis of frontal fibrosing alopecia established by a dermatologist specialized in hair disorders; presence of inflammatory signs of frontal fibrosing alopecia; no treatment for frontal fibrosing alopecia within the 30 days prior to study enrollment; participants with reproductive potential using an effective contraceptive method throughout the study; willingness to participate in the study by signing the Informed Consent Form
Exclusion criteria
Exclusion criteria: Uncontrolled hypertension; severe heart disease; severe kidney disease; pregnancy; breastfeeding; other inflammatory scalp diseases; contraindication to the use of tofacitinib or dutasteride; use of medications that may interfere with the assessment of the study outcomes; concomitant diseases that may compromise participation or the interpretation of the study results; refusal to sign the Informed Consent Form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in frontal fibrosing alopecia disease activity is expected, assessed by the change in the Lichen Planopilaris Activity Index score measured at weeks 0, 12 and 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| A reduction in frontal hairline hair loss progression is expected, assessed by trichoscopy with hair count in the target area at weeks 0, 12 and 24;A reduction in frontal hairline hair loss progression is expected, assessed by standardized photographs evaluated by three dermatologists blinded to treatment using a five-point scale at weeks 0, 12 and 24;A reduction in frontal hairline hair loss progression is expected, assessed by changes in the frontal hairline distance measured at weeks 0, 12 and 24;A reduction in perifollicular erythema and scaling is expected, assessed by dermoscopy using a five-point scale at weeks 0, 12 and 24;An improvement in eyebrow and eyelash loss is expected, assessed by standardized photographs evaluated by three dermatologists blinded to treatment using a five-point scale at weeks 0, 12 and 24;An improvement in quality of life is expected, assessed by changes in the Brazilian version of the Frontal Fibrosing Alopecia Quality of Life Index administered at weeks 0, 12 and 24;A reduction in disease progression is expected, assessed by changes in the Frontal Fibrosing Alopecia Global Staging Score measured at weeks 0, 12 and 24;Good treatment tolerability and a low frequency of adverse events are expected throughout the 24-week follow-up period | — |
Countries
BR
Contacts
Public ContactAndre Donda
Hospital Universitario Pedro Ernesto
Outcome results
None listed