Efficacy of Combined Microneedling With Methotrexate in Treatment of Alopecia Areata
NCT ID: NCT05485571
Last Updated: 2022-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2022-08-01
2023-02-01
Brief Summary
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The prevalence of the disease is 0.2% in the general population with higher prevelance in younger (21-40 years of age) patients but no significant difference in incidence between males and females.
Several treatment options such as corticosteroids, anthralin, topical minoxidil, immunotherapy, and systemic therapy are commonly used with varying response . Unfortunately the traditional treatment options are frequently disappointing Available treatments may induce regrowth but do not modify the disease course .
Methotrexate (MTX) is a folic acid analog that binds to the dihydrofolate reductase enzyme, blocking the formation of tetrahydrofolate and so inhibits purine and pyrimidine metabolism and consequently nucleic acid synthesis. It acts as an immunosuppressant used in the treatment of several skin diseases Systemic MTX has been used in the treatment of AA, with satisfactory results. Microneedling is a minimally invasive procedure that utilizes multiple fine needles to create micropunctures in the skin.The act of creating these two to four cell-wide puncture holes triggers neovascularization, release of growth factors, and stimulates the expression of Wnt proteins. it has specifically been demonstrated to increase hair regrowth in alopecia via the release of platelet-derived growth factor, epidermal growth factors and activation of the hair bulge, all of which are triggered by the wound healing response .Increased expression of Wnt proteins, namely Wnt3a and Wnt10b, is also evident following microneedling. These particular proteins have been demonstrated to stimulate dermal papillae stem cells and hair growth.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GROUP 1
15 patient with alopecia areata treated by microneedling only one session weekly for 12 weeks
derma pen
Group 1: Taking aseptic condition, 15 Patients were subjected to therapy with microneedling, patient will take session weekly for 12 weeks.
Group 2: Taking aseptic condition, 15 patients were subjected to combined therapy with Microneedling and methotrexate After microneedling we applied methotrexate topically (25mg/ml) at dose 0.02ml/cm2 , A maximum of 0.1-0.2ml (2.5-5 mg) on the affected areas and rub it gently then Microneedling again, patient will take session weekly for 12 weeks
GROUP 2
15 patient with alopecia areata treated by combined therapy with Microneedling and methotrexate After microneedling we applied methotrexate topically (25mg/ml) at dose 0.02ml/cm2 , A maximum of 0.1-0.2ml (2.5-5 mg) on the affected areas and rub it gently then Microneedling again, patient will take session weekly for 12 weeks.
derma pen
Group 1: Taking aseptic condition, 15 Patients were subjected to therapy with microneedling, patient will take session weekly for 12 weeks.
Group 2: Taking aseptic condition, 15 patients were subjected to combined therapy with Microneedling and methotrexate After microneedling we applied methotrexate topically (25mg/ml) at dose 0.02ml/cm2 , A maximum of 0.1-0.2ml (2.5-5 mg) on the affected areas and rub it gently then Microneedling again, patient will take session weekly for 12 weeks
Interventions
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derma pen
Group 1: Taking aseptic condition, 15 Patients were subjected to therapy with microneedling, patient will take session weekly for 12 weeks.
Group 2: Taking aseptic condition, 15 patients were subjected to combined therapy with Microneedling and methotrexate After microneedling we applied methotrexate topically (25mg/ml) at dose 0.02ml/cm2 , A maximum of 0.1-0.2ml (2.5-5 mg) on the affected areas and rub it gently then Microneedling again, patient will take session weekly for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patients with chronic hepatic, hematological disorders or immunocompromised patients.
* patient recieved any treatment for alopecia areata in the last 3 months before the study.
* patients with extensive types (alopecia totalis, universalis and surface area \>50%).
18 Years
40 Years
ALL
No
Sponsors
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Sohag University
OTHER
Responsible Party
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Asmaa Awad Hassanin
resident doctor at Dematology, Venereology and Andrology department at Gerga Hospital
Locations
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Sohag University Hospital
Sohag, , Egypt
Countries
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Central Contacts
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wafaa M abd-elmagid
Role: CONTACT
Facility Contacts
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Osama R Elshrif, professor
Role: primary
References
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Gilhar A, Paus R, Kalish RS. Lymphocytes, neuropeptides, and genes involved in alopecia areata. J Clin Invest. 2007 Aug;117(8):2019-27. doi: 10.1172/JCI31942.
Hou A, Cohen B, Haimovic A, Elbuluk N. Microneedling: A Comprehensive Review. Dermatol Surg. 2017 Mar;43(3):321-339. doi: 10.1097/DSS.0000000000000924.
Dhurat R, Sukesh M, Avhad G, Dandale A, Pal A, Pund P. A randomized evaluator blinded study of effect of microneedling in androgenetic alopecia: a pilot study. Int J Trichology. 2013 Jan;5(1):6-11. doi: 10.4103/0974-7753.114700.
Bressan AL, Silva RS, Fontenelle E, Gripp AC. [Immunosuppressive agents in Dermatology]. An Bras Dermatol. 2010 Jan-Feb;85(1):9-22. doi: 10.1590/s0365-05962010000100002. Portuguese.
Other Identifiers
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Soh-Med-22-07-07
Identifier Type: -
Identifier Source: org_study_id
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