Comparative Study Efficacy and Safety of of Activated Versus Non-Activated PRP

Study Overview
=================
Brief Summary
-----------------
This was comparative prospective study conducted on 40 subjects, diagnosed with alopecia areata of 40 the scalp, carried in a period from February 2020 and March 2021

Detailed Description
-----------------
Alopecia areata is a common recurrent T cell-mediated autoimmune-induced non-scarring hair loss with not fully understood pathogenesis which affects nearly 2% of the general population during lifetime. The course of the disease is unpredictable and currently, no treatment is available for complete cure or prevention. Platelet-rich plasma is an autologous blood-derived product which widely spread in the last decades for the treatment of different dermatological conditions including different hair disorders. The aim of this work was to evaluate the efficacy and safety of activated platelet-rich plasma in comparison to non-activated platelet-rich plasma in the treatment of alopecia areata.

Official Title
-----------------
Evaluation of Activated Platelet Rich Plasma Versus Non-Activated Platelet Rich Plasma in Alopecia Areata

Conditions
-----------------
Alopecia Areata

Intervention / Treatment
-----------------
* Drug: Intradermal injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed clinically and dermatoscopically as Alopecia areata of the scalp (uni- or 50 multilocularis). Age ranged between 18-50 years in both sex. Exclusion criteria: Previously treated patients. Pregnant women. 3 Patients with hematological disorders. 4. Local infection at the site. 5. Patients with Hemoglobin <10 g/dL and Platelet count <105/µL. 6. Patients suffer from chronic and psychiatric diseases. 7.Age below 18years or age above 50 years ago.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The 40 patients with alopecia areata will be divided into 2 groups: Group A: 20 patients will be treated by activated PRP with Calcium chloride (CaCl2). Those patients will be treated with an intradermal injection. Group B: 20 patients will be treated by non-activated PRP through intradermal injection
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Activated plasma rich in platelets<br>Group A: patients were treated by intradermal injections of PRP activated with Calcium chloride 10% solution. | Drug: Intradermal injection<br>* Platelet-rich plasma (PRP) therapy uses injections of a concentration of a patient's own platelets.<br>* Other names: Plasma rich in platelets;|
| Placebo Comparator: Non- activated plasma rich in platelets<br>Group B: patients were treated by intradermal injections of PRP without activation. | Drug: Intradermal injection<br>* Platelet-rich plasma (PRP) therapy uses injections of a concentration of a patient's own platelets.<br>* Other names: Plasma rich in platelets;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair length in group A | PRP as treatment option was in indicating its anti-inflammatory properties. 183 PRP effective in AA through anti-inflammatory mechanisms owing to its ability to suppress Monocyte 184 chemotactic protein-1 and owing to the presence of Transforming growth factor (β1 and β2) as was 185 shown by Amable and El-Sharkavy with coauthors | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair length in Group B | confirm that PRP is safe effective and well tolerated by 207 patients treatment modality for Alopecia areata. Beside this such method is cost effective as no need 208 any expensive tools for preparation and can be done in outpatients clinics easily. | five months |