Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06327581
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-03-18
Brief Title:
Combined Microneedling With Either 1 Lactic Acid Solution or Vitamin D3 or Triamcinolone Acetonide in The Treatment of Alopecia Areata
Sponsor:
Zagazig University
Organization:
Zagazig University
Study Overview
Official Title:
Comparative Study of Combined Microneedling With Either 1 Lactic Acid Solution or Vitamin D3 or Triamcinolone Acetonide in The Treatment of Alopecia Areata
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Alopecia areata AA is an immunologically mediated disease characterized by non-scarring hair loss Madni and Shapiro 2000 AA is presented by rapid and complete hair loss in one or more round or oval patches usually on the scalp beard area eyebrows eyelashes and less commonly on other hairy areas of the body Berker et al 2010 and James et al 2011 Alopecia areata is a T-cell-mediated autoimmune disease There is a complicated interplay between loss of immune privilege in the hair follicle autoimmune-mediated hair follicle damage and activation of inflammatory pathways that have been argued to explain the development of this disorder but the exact pathophysiology of AA remains unknown Hair follicles are infiltrated by autoreactive CD8 and CD4 T lymphocytes which attack hair follicle-derived autoantigens while sparing the stem compartment Rajabi et al 2018
Alopecia areata can be treated with topical andor intralesional corticosteroids which are the treatment of choice Anthralin minoxidil coal tar and topical immunotherapy are examples of other topical treatments Systemic immunosuppressants such as cyclosporine systemic steroids Janus kinase inhibitors and methotrexate may be considered in severe resistant cases lee and lee 2017
Intralesional triamcinolone acetonide is preferred in cases of AA as it is well known as anti-inflammatory and interferes with local immunity of the skin which helps in the recovery of the disease but if used in wrong technique or given in a high dose it might cause all the side effects of corticosteroid especially skin atrophy Berker et al 2010
Lactic acid is a member of alpha-hydroxy acids It has been used in the treatment of many skin diseases like AA and vitiligo Lactic acid stimulates spontaneous secretion of vascular endothelial growth factor VEGF by human reconstructed epidermis VEGF is an angiogenic cytokine involved in angiogenesis and wound healing and stimulates the growth of hair follicles resulting in recovery of AA Other studies suggest that lactic acid may act through its irritant effect Al-Tammimy 2005
Vitamin D interacts with the innate and adaptive immune systems in a variety of ways the majority of which contribute to its downregulation Nancy and Yehuda 2009 It has a powerful effect on T and B lymphocytes influencing their activation responses Arnson et al 2007
All cells of the immune system express 125-dihydroxyvitamin D3 receptors VDRs and are therefore vulnerable to calcitriol-mediated modulation Vitamin D3 has the ability to influence the migration and maturation of different dendritic cell subtypes and their production of chemokines and cytokines giving them an immunoregulatory and tolerogenic role Illescas-Montes et al 2019 It has been shown that VDRs are highly expressed in the keratinocytes of human hair follicles and the absence of their expression is associated with reduced hair follicle growth and epidermal differentiation Reduced VDR expression in the hair follicles of affected areas has also been observed in studies of AA patients scalp Çerman et al 2015
Microneedling MN is a technique that comprises puncturing the skin repeatedly with sterile microneedles Iriarte et al 2017 It promotes hair regeneration by triggering stem cells in the hair bulge which results in the generation of growth factors It also improves blood circulation to the hair follicles and influences the local immune cells Chandrashekar et al 2014 Moreover combining MN with applied topical drugs facilitates their absorption through the microchannels created within the epidermis Fertig et al 2018
Alopecia areata can be treated with topical andor intralesional corticosteroids which are the treatment of choice Anthralin minoxidil coal tar and topical immunotherapy are examples of other topical treatments Systemic immunosuppressants such as cyclosporine systemic steroids Janus kinase inhibitors and methotrexate may be considered in severe resistant cases lee and lee 2017
Intralesional triamcinolone acetonide is preferred in cases of AA as it is well known as anti-inflammatory and interferes with local immunity of the skin which helps in the recovery of the disease but if used in wrong technique or given in a high dose it might cause all the side effects of corticosteroid especially skin atrophy Berker et al 2010
Lactic acid is a member of alpha-hydroxy acids It has been used in the treatment of many skin diseases like AA and vitiligo Lactic acid stimulates spontaneous secretion of vascular endothelial growth factor VEGF by human reconstructed epidermis VEGF is an angiogenic cytokine involved in angiogenesis and wound healing and stimulates the growth of hair follicles resulting in recovery of AA Other studies suggest that lactic acid may act through its irritant effect Al-Tammimy 2005
Vitamin D interacts with the innate and adaptive immune systems in a variety of ways the majority of which contribute to its downregulation Nancy and Yehuda 2009 It has a powerful effect on T and B lymphocytes influencing their activation responses Arnson et al 2007
All cells of the immune system express 125-dihydroxyvitamin D3 receptors VDRs and are therefore vulnerable to calcitriol-mediated modulation Vitamin D3 has the ability to influence the migration and maturation of different dendritic cell subtypes and their production of chemokines and cytokines giving them an immunoregulatory and tolerogenic role Illescas-Montes et al 2019 It has been shown that VDRs are highly expressed in the keratinocytes of human hair follicles and the absence of their expression is associated with reduced hair follicle growth and epidermal differentiation Reduced VDR expression in the hair follicles of affected areas has also been observed in studies of AA patients scalp Çerman et al 2015
Microneedling MN is a technique that comprises puncturing the skin repeatedly with sterile microneedles Iriarte et al 2017 It promotes hair regeneration by triggering stem cells in the hair bulge which results in the generation of growth factors It also improves blood circulation to the hair follicles and influences the local immune cells Chandrashekar et al 2014 Moreover combining MN with applied topical drugs facilitates their absorption through the microchannels created within the epidermis Fertig et al 2018
Detailed Description:
Patients in all groups will be subjected to microneedling MN using a dermapen DrPen with adjustable needle length ranging from 15 to 2 mm using the highest speed level 4-5 First topical anesthetic cream will be applied Then they will be stroked by dermapen diagonally vertically and horizontally in a repeated manner until pinpoint bleeding appears which will be regarded as an endpoint
First group A 11 AA patients will be treated with MN combined with lactic acid solution 1 Lactic acid solution 88 concentration PH 684 diluted with distilled water to have a final concentration of 1 Sharquis et al 2015
Second group B 11 AA patients will be treated with MN combined with topical application of vitamin D3 an aqueous preparation of cholecalciferol Devarol ampoule 200 000 IU2 ml Memphis Egypt 25 mg ml The maximum total amount of vitamin D3 injected into a patient in every session will be 25 mg 1 ml Ali et al 2023
Third group C 11 AA patients will be treated with MN combined with triamcinolone acetonide injectable suspension Epirelefan 40mg ml Eipico Egypt 10 mgml will be used in a dose of 01 mlcm2 area Arora et al 2022
Fourth group D 11 AA patients will be treated with MN combined with normal saline 09 In all groups sessions were done every 2 weeks for a maximum of six sessions V Photographs will be taken by Iphone 13 pro max Camera before during and after treatment
First group A 11 AA patients will be treated with MN combined with lactic acid solution 1 Lactic acid solution 88 concentration PH 684 diluted with distilled water to have a final concentration of 1 Sharquis et al 2015
Second group B 11 AA patients will be treated with MN combined with topical application of vitamin D3 an aqueous preparation of cholecalciferol Devarol ampoule 200 000 IU2 ml Memphis Egypt 25 mg ml The maximum total amount of vitamin D3 injected into a patient in every session will be 25 mg 1 ml Ali et al 2023
Third group C 11 AA patients will be treated with MN combined with triamcinolone acetonide injectable suspension Epirelefan 40mg ml Eipico Egypt 10 mgml will be used in a dose of 01 mlcm2 area Arora et al 2022
Fourth group D 11 AA patients will be treated with MN combined with normal saline 09 In all groups sessions were done every 2 weeks for a maximum of six sessions V Photographs will be taken by Iphone 13 pro max Camera before during and after treatment
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?:
None
Is an FDA AA801 Violation?:
None