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Efficacy of Combined Microneedling With Methotrexate in Treatment of Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
derma pen
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept 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%).

Sites / Locations

  • Sohag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

GROUP 1

GROUP 2

Arm Description

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

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.

Outcomes

Primary Outcome Measures

regrowth scale
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
Mcdonald Hull and Norris Regrowth Scale (by trichoscope)
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.

Secondary Outcome Measures

Full Information

First Posted
July 24, 2022
Last Updated
August 2, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05485571
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GROUP 1
Arm Type
Active Comparator
Arm Description
15 patient with alopecia areata treated by microneedling only one session weekly for 12 weeks
Arm Title
GROUP 2
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
derma pen
Other Intervention Name(s)
methotrexate
Intervention Description
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
Primary Outcome Measure Information:
Title
regrowth scale
Description
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
Time Frame
6 months
Title
Mcdonald Hull and Norris Regrowth Scale (by trichoscope)
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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%).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
asmaa A hassanin, resident
Phone
01099773736
Email
asmaa_ali@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
wafaa M abd-elmagid
Phone
01008813349
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R Elshrif, professor

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
17671634
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.
Results Reference
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PubMed Identifier
27755171
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.
Results Reference
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PubMed Identifier
23960389
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.
Results Reference
background
PubMed Identifier
20464082
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.
Results Reference
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Efficacy of Combined Microneedling With Methotrexate in Treatment of Alopecia Areata

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