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Methotrexate Versus Triamcinilone Acetonide in Treatment of Recalcitrant Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Methotrexate
Triamcinolone Acetonide
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia areata, Methotrexate, Triamcinolone, microneedling

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age groups: > 12 years old. Sex: both sexes. Co-operative Patients. Recalcitrant or resistant cases to treatment (meaning that all patients had received various modalities of treatment in the past with poor/partial response or relapse after discontinuing therapy. Exclusion Criteria: Patients <12 years. Pregnant and lactating women. Patients with any underlying Systemic disorders. Patients with HBV or HCV. Patient with active infection of T.B. Patients with bone marrow suppression (leukopenia, thrombocytopenia) Patients who had received any other modalities of treatment in last 3-6 months.

Sites / Locations

  • Al-Azhar University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1= Methotrexate

Group2=Triamcinilone

Arm Description

After microneedling, we will apply methotrexate topically (25 mg/ml) on half of the scalp at a dose of 0.02ml/cm2 with a maximum of 0.1-0.2 ml (2,5-5 mg) and rub it gently. The patient will take a session every 2 weeks for 12 weeks, on the same patient on the other patch or half of the scalp according to the pattern.

we will use Triamcinolone acetonide 40 mg/1ml after microneedking at dose 5mg/ml concentration;1/8/ 1:7 dilution session every 3 weeks for 12 weeks. then after 12 weeks of treatment we will follow up our patients after discontinuing therapy for other 12 weeks and evaluate.

Outcomes

Primary Outcome Measures

To evaluate the efficacy of methotrexate with microneedling versus triamcinolone with microneedling in treatment of recalcitrant alopecia areata.
Mcdonald Hull and Norris regrowth scale by trichoscope (Time frame 6 months). Grade 1: Regrowth of vellus hair, Grade 2: Regrowth of sparse pigmented terminal hair (<50% increment in % SALT score according to NAAF guideline), Grade 3: regrowth of terminal hair with patches of alopecia (50-75% increase in % SALT score), Grade 4: regrowth of terminal hair on the whole alopecia patch (> 75% increase in% SALT score).

Secondary Outcome Measures

Full Information

First Posted
August 25, 2023
Last Updated
October 11, 2023
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT06088147
Brief Title
Methotrexate Versus Triamcinilone Acetonide in Treatment of Recalcitrant Alopecia Areata
Official Title
Methotrexate With Microneedling Versus Triamcinilone Acetonide With Microneedling in Treatment of Recalcitrant Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar 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 is the second most common cause of hair loss following androgenic alopecia. It is affecting 2% of global population with an increasing prevalence. Briefly, it is a chronic, immunomediated disease characterized by acute onset of non-scarring hair loss ranging from small circumscribed patchy areas on the scalp to complete scalp and body hair loss. Until recently our understanding of the pathophysiology of alopecia areata is scarce, despite being so common. Methotrexate is an immunosuppressant drug that has been widely used for a range of inflammatory and immune-mediated skin disorders. Methotrexate has been recently proven to inhibit Jak/STAT Pathway. Triamcinolone acetonide as another type of treatment of alopecia areata either intralesionally or topically remains the first line of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Alopecia areata, Methotrexate, Triamcinolone, microneedling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1= Methotrexate
Arm Type
Active Comparator
Arm Description
After microneedling, we will apply methotrexate topically (25 mg/ml) on half of the scalp at a dose of 0.02ml/cm2 with a maximum of 0.1-0.2 ml (2,5-5 mg) and rub it gently. The patient will take a session every 2 weeks for 12 weeks, on the same patient on the other patch or half of the scalp according to the pattern.
Arm Title
Group2=Triamcinilone
Arm Type
Experimental
Arm Description
we will use Triamcinolone acetonide 40 mg/1ml after microneedking at dose 5mg/ml concentration;1/8/ 1:7 dilution session every 3 weeks for 12 weeks. then after 12 weeks of treatment we will follow up our patients after discontinuing therapy for other 12 weeks and evaluate.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
A standard derma pen 12 pins with of 0,5 mm depth was used, dermapen as a tool of infusion of our treatments works in a few ways to target hair loss, firstly by breaking down the scar tissue that covers or compromises the hair follicles which are not growing, stimulating new hair growth and also by enhancing infusion of mesotherapy ingredients to increase hair follicle size and therefore hair volume ,here we will use it by stamping technique, the procedure was practically painless and therefore no local anesthesia was used, however For those who will not want to tolerate pain, topical anesthesia with 2% lignocaine, under occlusion will applied, the patients will be followed up for 6 months after full course of treatment. Then we will apply methotrexate topically (25 mg/ml) on half of the scalp at a dose of 0.02ml/cm2
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Intervention Description
A standard derma pen 12 pins with of 0,5 mm depth was used, will use it by stamping technique, the procedure was practically painless and therefore no local anesthesia was used, however For those who will not want to tolerate pain, topical anesthesia with 2% lignocaine, under occlusion will applied, the patients will be followed up for 6 months after full course of treatment. Then Triamcinolone acetonide 40 mg/1ml after microneedking at dose 5mg/ml concentration;1/8/ 1:7 dilution
Primary Outcome Measure Information:
Title
To evaluate the efficacy of methotrexate with microneedling versus triamcinolone with microneedling in treatment of recalcitrant alopecia areata.
Description
Mcdonald Hull and Norris regrowth scale by trichoscope (Time frame 6 months). Grade 1: Regrowth of vellus hair, Grade 2: Regrowth of sparse pigmented terminal hair (<50% increment in % SALT score according to NAAF guideline), Grade 3: regrowth of terminal hair with patches of alopecia (50-75% increase in % SALT score), Grade 4: regrowth of terminal hair on the whole alopecia patch (> 75% increase in% SALT score).
Time Frame
6 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
microneedling is a painful technique so patients <12 years will be excluded
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age groups: > 12 years old. Sex: both sexes. Co-operative Patients. Recalcitrant or resistant cases to treatment (meaning that all patients had received various modalities of treatment in the past with poor/partial response or relapse after discontinuing therapy. Exclusion Criteria: Patients <12 years. Pregnant and lactating women. Patients with any underlying Systemic disorders. Patients with HBV or HCV. Patient with active infection of T.B. Patients with bone marrow suppression (leukopenia, thrombocytopenia) Patients who had received any other modalities of treatment in last 3-6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Athar Fathy Abodief
Phone
01030055632
Email
atharfathy.2344@azhar.edu.eg
Facility Information:
Facility Name
Al-Azhar University
City
Assiut
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athar Fathy Abodief
Phone
01030055632

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Methotrexate Versus Triamcinilone Acetonide in Treatment of Recalcitrant Alopecia Areata

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