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

Alopecia Areata Clinical Trial

Official title:

Evaluation of Activated Platelet Rich Plasma Versus Non-Activated Platelet Rich Plasma in Alopecia Areata

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05251831
• Other study ID #: Ahmed HN AA
• Status: Completed
• Phase: Early Phase 1
• Start date: February 1, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: February 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 30, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Intradermal injection
Platelet-rich plasma (PRP) therapy uses injections of a concentration of a patient's own platelets.

Locations

Country	Name	City	State
Egypt	Al-Azhar University in Cairo	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. Review. — View 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. Review. — View Citation

Kuty-Pachecka M. Psychological and psychopathological factors in alopecia areata. Psychiatr Pol. 2015;49(5):955-64. doi: 10.12740/PP/39064. Review. English, Polish. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (ß1 and ß2) as was 185 shown by Amable and El-Sharkavy with coauthors	three months
Secondary	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.	five months