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

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Intradermal injection
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesAccepts 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.

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.

Sites / Locations

  • Al-Azhar University in Cairo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Activated plasma rich in platelets

Non- activated plasma rich in platelets

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
January 2, 2022
Last Updated
February 12, 2022
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05251831
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Activated plasma rich in platelets
Arm Type
Experimental
Arm Description
Group A: patients were treated by intradermal injections of PRP activated with Calcium chloride 10% solution.
Arm Title
Non- activated plasma rich in platelets
Arm Type
Placebo Comparator
Arm Description
Group B: patients were treated by intradermal injections of PRP without activation.
Intervention Type
Drug
Intervention Name(s)
Intradermal injection
Other Intervention Name(s)
Plasma rich in platelets
Intervention Description
Platelet-rich plasma (PRP) therapy uses injections of a concentration of a patient's own platelets.
Primary Outcome Measure Information:
Title
Hair length in group A
Description
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
Time Frame
three months
Secondary Outcome Measure Information:
Title
Hair length in Group B
Description
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.
Time Frame
five months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Mohamed abdelaal, Prof
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Azhar University in Cairo
City
Cairo
ZIP/Postal Code
11311
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21544079
Citation
Aithal GP, Watkins PB, Andrade RJ, Larrey D, Molokhia M, Takikawa H, Hunt CM, Wilke RA, Avigan M, Kaplowitz N, Bjornsson E, Daly AK. Case definition and phenotype standardization in drug-induced liver injury. Clin Pharmacol Ther. 2011 Jun;89(6):806-15. doi: 10.1038/clpt.2011.58. Epub 2011 May 4.
Results Reference
background
PubMed Identifier
29457008
Citation
Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018 Jan;4(1):18-24. doi: 10.1159/000477353. Epub 2017 Jul 6.
Results Reference
background
PubMed Identifier
26688846
Citation
Kuty-Pachecka M. Psychological and psychopathological factors in alopecia areata. Psychiatr Pol. 2015;49(5):955-64. doi: 10.12740/PP/39064. English, Polish.
Results Reference
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PubMed Identifier
23289098
Citation
Li F, Ohnishi R, Yamada Y, Kubota J, Domen K, Yamada A, Zhou H. Carbon supported TiN nanoparticles: an efficient bifunctional catalyst for non-aqueous Li-O2 batteries. Chem Commun (Camb). 2013 Feb 11;49(12):1175-7. doi: 10.1039/c2cc37042e.
Results Reference
background
PubMed Identifier
29241771
Citation
Strazzulla LC, Wang EHC, Avila L, Lo Sicco K, Brinster N, Christiano AM, Shapiro J. Alopecia areata: Disease characteristics, clinical evaluation, and new perspectives on pathogenesis. J Am Acad Dermatol. 2018 Jan;78(1):1-12. doi: 10.1016/j.jaad.2017.04.1141.
Results Reference
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Comparative Study Efficacy and Safety of of Activated Versus Non-Activated PRP

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