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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

First Submitted

Initial submission to the registry

July 24, 2022

Completed

8 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed

Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

July 24, 2022

Last Update Submit

August 2, 2022

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (2)

regrowth scale
0 score (regrowth \< 10%) no response 1. score (regrowth 11-25%) poor response 2. score (regrowth 26-50%) fair response 3. score (regrowth 51-75%) satisfactory response 4. score (regrowth ≥ 75%) excellent response
6 months
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.
6 months

Study Arms (2)

GROUP 1

ACTIVE COMPARATOR

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

Device: derma pen

GROUP 2

ACTIVE COMPARATOR

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

Interventions

derma penDEVICE

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

Also known as: methotrexate

GROUP 1GROUP 2

Eligibility Criteria

Age18 Years - 40 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

\- The study will include patients with alopecia areata

You may not qualify if:

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%).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Sohag Universitylead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

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.
PMID: 17671634BACKGROUND
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.
PMID: 27755171BACKGROUND
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.
PMID: 23960389BACKGROUND
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.
PMID: 20464082BACKGROUND

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

asmaa A hassanin, resident

CONTACT

01099773736 asmaa_ali@med.sohag.edu.eg

wafaa M abd-elmagid

CONTACT

01008813349

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: resident doctor at Dematology, Venereology and Andrology department at Gerga Hospital

Study Record Dates

First Submitted

July 24, 2022

First Posted

August 3, 2022

Study Start

August 1, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing: Will share

Locations

EG(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

GROUP 1

GROUP 2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations