Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278402
Status:
COMPLETED
Last Update Posted:
2024-02-26
First Post:
2024-01-28
Brief Title:
Efficacy of Oral Tofacitinib in Moderate to Severe Alopecia Areata Totalis and Universalis at Tertiary Care Hospital Karachi
Sponsor:
Jinnah Hospital
Organization:
Jinnah Hospital
Study Overview
Official Title:
Efficacy of Oral Tofacitinib in Moderate to Severe Alopecia Areata Totalis and Universalis at Tertiary Care Hospital Karachi
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 612 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
Detailed Description:
Alopecia areata is a chronic autoimmune non-scarring alopecia that involves the destruction of hair follicles HF by autoreactive CD8 T cells AA can affect any hair-bearing region and can manifest in various patterns ranging from patchy diffuse alopecia to progression to more severe forms such as alopecia totalis AT or alopecia universalis AU As a common type of alopecia in human the estimated prevalence of AA is approximately between 01 and 02 second only to male and female pattern alopecia Although it is not life threatening but the psychosocial impact of the disease is a concern The treatment of advanced forms of alopecia areata AA is more challenging than the milder forms and patients with advanced AA often require systemic therapy in order to regrow hair
Current treatments include steroids intralesional topical and systemic topical immunotherapy diphenylcyclopropenone DPCP squaric acid dibutylester SADBE topical immunosuppressants tacrolimus pimecrolimus topical minoxidil and topical prostaglandin analogs bimatoprost latanoprost
Significant breakthroughs in understanding of intracellular cytokine signaling pathways have promoted a dawn of new promising therapeutic agents known as Janus kinase inhibitors JAKs which block signaling of certain cytokines by inhibiting ATP binding within the phosphorylation sites of cytokine receptor homo- or heterodimers thereby interrupting the JAKsignal transducer and activator of transcription STAT pathway and subsequently production of pro-inflammatory cytokines and other mediators associated with AA
Despite the rapid development of novel JAK inhibitors including baricitinib and ritlecitinib tofacitinib remains an effective and the longest-used JAK inhibitor for AA Tofacitinib primarily targets JAK 13 and reduces the immune response and resultant inflammation emerging as an alternative for the treatment of refractory cases of AA
In 2014 the first reported case using a JAK13 inhibitor tofacitinib citrate for the treatment of AU was described in a patient with concomitant plaque psoriasis who achieved full regrowth of hair within 8 months Since then the scientific understanding of AA has continued to progress highlighting the key role that cytotoxic T lymphocytes play in AA and the potential of JAK inhibition Due to the lack of data regarding efficacy and safety of this drug in alopecia areata we therefore aim to provide a comprehensive literature evaluate the effectiveness outcome and role of Tofacitinib in the treatment of AA
Current treatments include steroids intralesional topical and systemic topical immunotherapy diphenylcyclopropenone DPCP squaric acid dibutylester SADBE topical immunosuppressants tacrolimus pimecrolimus topical minoxidil and topical prostaglandin analogs bimatoprost latanoprost
Significant breakthroughs in understanding of intracellular cytokine signaling pathways have promoted a dawn of new promising therapeutic agents known as Janus kinase inhibitors JAKs which block signaling of certain cytokines by inhibiting ATP binding within the phosphorylation sites of cytokine receptor homo- or heterodimers thereby interrupting the JAKsignal transducer and activator of transcription STAT pathway and subsequently production of pro-inflammatory cytokines and other mediators associated with AA
Despite the rapid development of novel JAK inhibitors including baricitinib and ritlecitinib tofacitinib remains an effective and the longest-used JAK inhibitor for AA Tofacitinib primarily targets JAK 13 and reduces the immune response and resultant inflammation emerging as an alternative for the treatment of refractory cases of AA
In 2014 the first reported case using a JAK13 inhibitor tofacitinib citrate for the treatment of AU was described in a patient with concomitant plaque psoriasis who achieved full regrowth of hair within 8 months Since then the scientific understanding of AA has continued to progress highlighting the key role that cytotoxic T lymphocytes play in AA and the potential of JAK inhibition Due to the lack of data regarding efficacy and safety of this drug in alopecia areata we therefore aim to provide a comprehensive literature evaluate the effectiveness outcome and role of Tofacitinib in the treatment of AA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None