Efficacy of Combined Microneedling With Methotrexate in Treatment of Alopecia Areata

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05485571
Collaborator
(none)
30
1
2
6
5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: derma pen
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Combined Microneedling With Methotrexate in Treatment of Alopecia Areata
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: GROUP 1

15 patient with alopecia areata treated by microneedling only one session weekly for 12 weeks

Device: 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 Names:
  • methotrexate
  • Active Comparator: 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.

    Device: 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 Names:
  • methotrexate
  • Outcome Measures

    Primary Outcome Measures

    1. regrowth scale [6 months]

      0 score (regrowth < 10%) no response score (regrowth 11-25%) poor response score (regrowth 26-50%) fair response score (regrowth 51-75%) satisfactory response score (regrowth ≥ 75%) excellent response

    2. Mcdonald Hull and Norris Regrowth Scale (by trichoscope) [6 months]

      Grade 1 - Regrowth of vellus hair. Grade 2 - Regrowth of sparse pigmented terminal hair. Grade 3 - Regrowth of terminal hair with patches of alopecia with patches of alopecia 50-75% in SALT score. Grade 4 - Regrowth of terminal hair on scalp with patches of alopecia > 75% in SALT score.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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%).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sohag University Hospital Sohag Egypt

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Asmaa Awad Hassanin, resident doctor at Dematology, Venereology and Andrology department at Gerga Hospital, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05485571
    Other Study ID Numbers:
    • Soh-Med-22-07-07
    First Posted:
    Aug 3, 2022
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 3, 2022