Extensive Alopecia Areata
Conditions
Keywords
alopecia areata, Tofacitinib, Efficacy, Safety, Hair loss
Brief summary
This clinical trial was conducted at the Dermatology department of Services hospital Lahore. Patients of extensive and treatment resistant Alopecia areata were enrolled after ethical approval and informed consent by non-probability consecutive sampling. Inclusion criteria: Treatment with oral tofacitinib citrate was initiated at 5 mg twice daily for six months. Scalp hair loss was calculated at 4, 12 and 24 weeks using the validated Severity of Alopecia Tool (SALT) score, which ranges from 0% to 100%. Regrowth rate: (initial SALT score - final SALT score)/(initial SALT score) × 100 was noted. Response time (time from initiation of treatment to any sign of hair regrowth) was noted. DLQI of patients before and after treatment were noted. Side effects were noted. Pre- and post-treatment photographs were taken. Patients were followed up for another 6 months to look for relapse. Data were entered and analyzed using SPSS 20. Means were calculated for quantitative variables, frequencies for qualitative data. Data were stratified for the role of effect modifiers.
Detailed description
This clinical trial was conducted at the Dermatology department of Services hospital Lahore. Patients of extensive and treatment resistant Alopecia areata were enrolled after ethical approval and informed consent by non-probability consecutive sampling. Treatment with oral tofacitinib citrate was initiated at 5 mg twice daily for six months after labs and ruling out contraindications. Scalp hair loss was calculated at 4, 12 and 24 weeks using the validated Severity of Alopecia Tool (SALT) score, which ranges from 0% to 100%. Regrowth rate: (initial SALT score - final SALT score)/(initial SALT score) × 100 was noted. Response time (time from initiation of treatment to any sign of hair regrowth) was noted. DLQI of patients before and after treatment were noted. Side effects were noted. Pre- and post-treatment photographs were taken. Patients were followed up for another 6 months to look for relapse. Data were entered and analyzed using SPSS 20. Means were calculated for quantitative variables, frequencies for qualitative data. Data were stratified for the role of effect modifiers.
Interventions
DRUGOral Tofacitinib citrate
oral tofacitinib citrate was initiated at 5 mg twice daily after ruling out contraindications
Sponsors
Services Institute of Medical Sciences, Pakistan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Either gender Age 18 to 60 years Extensive disease (SALT \> 24)
Exclusion criteria
* Patients taking immunosuppressants or DMARDs Recent live vaccination Active or latent TB, Hepatitis B or C, HIV Malignancy Hypersensitivity to the drug Pregnant or lactating mothers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 50% reduction in Severity of Alopecia Tool (SALT) | within 24 weeks | atleast 50% reduction of SALT score from baseline (pre-treatment) |
| 50% reduction in Dermatology Life Quality Index (DLQI) | within 24 weeks | Atleast 50% improvement in quality of life of patients by reduction in DLQI from baseline (pre-treatment) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Regrowth rate | within 24 weeks | (initial SALT score - final SALT score)/(initial SALT score) × 100 |
| Response time | within 24 weeks | time from initiation of treatment to any sign of hair regrowth |
Countries
Pakistan
Outcome results
None listed