Alopecia Areata Clinical Trial
Official title:
Efficacy of Oral Tofacitinib in Moderate to Severe Alopecia Areata, Totalis and Universalis at Tertiary Care Hospital, Karachi.
Verified date | February 2024 |
Source | Jinnah Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine the efficacy of oral Tofacitinib in the treatment of moderate to severe alopecia areata, totalis and universalis at tertiary care hospital of Karachi, Pakistan. Efficacy of treatment in patients presenting with alopecia areata will be assessed using SALT Score on follow up at 6,12 and 24 weeks where four categories of treatment response were defined: 0 (re-growth ≤10%), 1 (11-25%), 2 (26-50%), 3 (51-75%) and 4 (re-growth >75%). Efficacy will be considered if re-growth ≥ 2.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 16, 2024 |
Est. primary completion date | January 6, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 60 Years |
Eligibility | Inclusion Criteria: - Patients presenting with Alopecia areata as per operational definition will be included in the study. - Either gender. - Age 15 - 60 years. Exclusion Criteria: - Patient with history of connective tissue disorders, vasculitis, seropositive and seronegative arthritis. - Patients having history of treatment with systemic agents, having active infection, pregnant and lactating women and patients having severe hematological abnormalities. - Patients positive for latent infections. - Patients with weight <25 kg. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Misbah Zari Qadir | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
Jinnah Hospital |
Pakistan,
Craiglow BG, King BA. Killing two birds with one stone: oral tofacitinib reverses alopecia universalis in a patient with plaque psoriasis. J Invest Dermatol. 2014 Dec;134(12):2988-2990. doi: 10.1038/jid.2014.260. Epub 2014 Jun 18. No abstract available. — View Citation
Damsky W, King BA. JAK inhibitors in dermatology: The promise of a new drug class. J Am Acad Dermatol. 2017 Apr;76(4):736-744. doi: 10.1016/j.jaad.2016.12.005. Epub 2017 Jan 28. — View Citation
Dillon KL. A Comprehensive Literature Review of JAK Inhibitors in Treatment of Alopecia Areata. Clin Cosmet Investig Dermatol. 2021 Jun 25;14:691-714. doi: 10.2147/CCID.S309215. eCollection 2021. — View Citation
Donovan J. The Evolving Story of JAK Inhibitors for Treating Alopecia Areata: A Review of Current Progress and Future Directions. Skin Therapy Lett. 2023 May;28(3):1-7. — View Citation
Gupta AK, Carviel JL, Foley KA, Shear NH, Piraccini BM, Piguet V, Tosti A. Monotherapy for Alopecia Areata: A Systematic Review and Network Meta-Analysis. Skin Appendage Disord. 2019 Nov;5(6):331-337. doi: 10.1159/000501940. Epub 2019 Aug 29. — View Citation
Huang J, Deng S, Li J, Tang Y, Liu F, Liu Y, Rao S, Shi W. Drug Survival and Long-term Outcome of Tofacitinib in Patients with Alopecia Areata: A Retrospective Study. Acta Derm Venereol. 2023 Nov 13;103:adv13475. doi: 10.2340/actadv.v103.13475. — View Citation
Husein-ElAhmed H, Abdulla N, Al-Obaidli A, Ali-Alam M, Steinhoff M. Real-world experience and long-term evaluation of tofacitinib in refractory alopecia areata: A prospective, open-label, single-center study in Asian Arab population. Dermatol Ther. 2022 D — View Citation
Liu LY, King BA. Tofacitinib for the Treatment of Severe Alopecia Areata in Adults and Adolescents. J Investig Dermatol Symp Proc. 2018 Jan;19(1):S18-S20. doi: 10.1016/j.jisp.2017.10.003. — View Citation
Pratt CH, King LE Jr, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017 Mar 16;3:17011. doi: 10.1038/nrdp.2017.11. — View Citation
Sardana K, Bathula S, Khurana A. Which is the Ideal JAK Inhibitor for Alopecia Areata - Baricitinib, Tofacitinib, Ritlecitinib or Ifidancitinib - Revisiting the Immunomechanisms of the JAK Pathway. Indian Dermatol Online J. 2023 Jun 28;14(4):465-474. doi: — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alopecia | To analyze the efficacy of oral Tofacitinib in moderate to severe alopecia areata, totalis and universalis at Tertiary Care Hospital, Karachi. The effect of treatment will be evaluated using photographs of the patient before and after the trial and clinical evaluation of patients. The clinical response for efficacy will be evaluated at 0, 6,12 and 24 weeks of therapy. Patient presenting with alopecia areata will be assessed for degree of improvement using SALT score on follow up after 3 months as follows: 0 (re-growth =10), 1 (11-25%), 2 (26-50%), 3 (51-75%) and 4 (re-growth >75%). Efficacy will be considered if re-growth =3. | 6 months |
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