Efficacy of Combined Microneedling With Methotrexate in Treatment of Alopecia Areata

S

Sohag University

Status

Not yet enrolling

Conditions

Alopecia Areata

Treatments

Device: derma pen

Study type

Interventional

Funder types

Other

Identifiers

NCT05485571
Soh-Med-22-07-07

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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%).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

GROUP 1
Active Comparator group
Description:
15 patient with alopecia areata treated by microneedling only one session weekly for 12 weeks
Treatment:
Device: derma pen
GROUP 2
Active Comparator group
Description:
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.
Treatment:
Device: derma pen

Trial contacts and locations

0

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Central trial contact

wafaa M abd-elmagid; asmaa A hassanin, resident

Data sourced from clinicaltrials.gov

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