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

Al-Azhar University

Status and phase: Completed; Early Phase 1

Conditions: Alopecia Areata

Treatments: Drug: Intradermal injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05251831

Ahmed HN AA

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Activated plasma rich in platelets

Experimental group

Description:

Group A: patients were treated by intradermal injections of PRP activated with Calcium chloride 10% solution.

Treatment:

Drug: Intradermal injection

Non- activated plasma rich in platelets

Placebo Comparator group

Description:

Group B: patients were treated by intradermal injections of PRP without activation.

Treatment:

Drug: Intradermal injection