Efficacy of Combined Microneedling With Methotrexate in Treatment of Alopecia Areata
- Conditions
- Alopecia Areata
- Interventions
- Device: derma pen
- Registration Number
- NCT05485571
- Lead Sponsor
- Sohag University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- The study will include patients with alopecia areata
- 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%).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GROUP 2 derma pen 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. GROUP 1 derma pen 15 patient with alopecia areata treated by microneedling only one session weekly for 12 weeks
- Primary Outcome Measures
Name Time Method regrowth scale 6 months 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 responseMcdonald 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sohag University Hospital
🇪🇬Sohag, Egypt