Clinical trial NCT05485571: Efficacy of Combined Microneedling With Methotrexate in Treatment of Alopecia Areata
Official title: Efficacy of Combined Microneedling With Methotrexate in Treatment of Alopecia Areata
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alopecia Areata
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Alopecia areata (AA) is a common cause of non-cicatricial hair loss It is the second-most frequent non-scarring alopecia, after androgenic alopecia.

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.


Eligibility criteria: Inclusion Criteria:

- The study will include patients with alopecia areata

Exclusion Criteria:

* Children below 18 years , pregnant and lactating women .
* 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%).

Primary outcomes:
measure: regrowth scale
timeFrame: 6 months
measure: Mcdonald Hull and Norris Regrowth Scale (by trichoscope)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.