Clinical trial NCT05251831: Comparative Study Efficacy and Safety of of Activated Versus Non-Activated PRP
Official title: Evaluation of Activated Platelet Rich Plasma Versus Non-Activated Platelet Rich Plasma in Alopecia Areata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alopecia Areata
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hair length in group A
timeFrame: three months
Secondary outcomes:
measure: Hair length in Group B
timeFrame: five months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University in Cairo
Study officials:
affiliation: Al-Azhar University
name: Ahmed Mohamed abdelaal, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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