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

Early Phase 1

Completed

• Conditions: Alopecia Areata
• Interventions: Drug: Intradermal injection

• Registration Number: NCT05251831
• Lead Sponsor: Al-Azhar University

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.

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-03-30
• Study First Submitted: 2022-01-02
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-12
• Last Update Submitted: 2022-02-12
• Study First Posted: 2022-02-23
• Last Update Posted: 2022-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients diagnosed clinically and dermatoscopically as Alopecia areata of the scalp (uni- or 50 multilocularis).
2. Age ranged between 18-50 years in both sex.

Exclusion criteria:

1. Previously treated patients.

2. Pregnant women. 3 Patients with hematological disorders.

3. 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Activated plasma rich in platelets	Intradermal injection	Group A: patients were treated by intradermal injections of PRP activated with Calcium chloride 10% solution.
Non- activated plasma rich in platelets	Intradermal injection	Group B: patients were treated by intradermal injections of PRP without activation.

Primary Outcome Measures

Name	Time	Method
Hair length in group A	three months	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

Secondary Outcome Measures

Name	Time	Method
Hair length in Group B	five months	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.

Trial Locations

Locations (1)

Al-Azhar University in Cairo; 🇪🇬 Cairo, Egypt