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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-03-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Alopecia Areata

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Activated plasma rich in platelets

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

Group Type EXPERIMENTAL

Intradermal injection

Intervention Type DRUG

Platelet-rich plasma (PRP) therapy uses injections of a concentration of a patient's own platelets.

Non- activated plasma rich in platelets

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

Group Type PLACEBO_COMPARATOR

Intradermal injection

Intervention Type DRUG

Platelet-rich plasma (PRP) therapy uses injections of a concentration of a patient's own platelets.

Interventions

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Intradermal injection

Platelet-rich plasma (PRP) therapy uses injections of a concentration of a patient's own platelets.

Intervention Type DRUG

Other Intervention Names

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Plasma rich in platelets

Eligibility Criteria

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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.

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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes