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

NCT05251831 | Completed Early Phase 1 FDA Drug

• 1 other identifier: Ahmed HN AA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• 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

  three months

Secondary Outcomes (1)

• Hair length in Group B

  five months

Study Arms (2)

Activated plasma rich in platelets

EXPERIMENTAL

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

Drug: Intradermal injection

Non- activated plasma rich in platelets

PLACEBO COMPARATOR

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

Drug: Intradermal injection

Interventions

Intradermal injection DRUG

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

Also known as: Plasma rich in platelets

Activated plasma rich in platelets; Non- activated plasma rich in platelets

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients diagnosed clinically and dermatoscopically as Alopecia areata of the scalp (uni- or 50 multilocularis).
• Age ranged between 18-50 years in both sex.

You may not qualify if:

• Previously treated patients.
• Pregnant women. 3 Patients with hematological disorders.
• \. 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University in Cairo

Cairo, 11311, Egypt

Location

Related 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.

  PMID: 21544079 BACKGROUND

• 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.

  PMID: 29457008 BACKGROUND

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

  PMID: 26688846 BACKGROUND

• 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.

  PMID: 23289098 BACKGROUND

• 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.

  PMID: 29241771 BACKGROUND

MeSH Terms

Conditions

Alopecia Areata

Interventions

Injections, Intradermal; Platelet Count

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Platelet Function Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Ahmed Mohamed abdelaal, Prof

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: January 2, 2022
• First Posted: February 23, 2022
• Study Start: February 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 30, 2021
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)