Retinol Binding Protein 4 Protein in Alopecia Areata Treated With Barcitinib

NCT06545110 | Active Not Recruiting Phase 1

• 1 other identifier: RBP4 in alopecia areata
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Assess serum and tissue retinol binding protein 4 in patients with severe alopecia areata in correlation with healthy individuals . Estimate genetic profile of retinol binding protein4 in severe alopecia areata patients Assess possible role of retinol binding protein 4 genetic mutation in response to barcitinib treatment in patients with severe alopecia areata .

Conditions

Alopecia Areata

Keywords

Retinol binding protein 4 , Barcitinib

Outcome Measures

Primary Outcomes (1)

• Assess serum and tissue retinol binding protein 4 in patients with severe alopecia

  Assess serum and tissue retinol binding protein 4 in patients with severe alopecia in serum and tissue samples in response to Baricitinib .

  baseline

Secondary Outcomes (1)

• Estimate genetic profile of retinol binding protein4 in severe alopecia areata patients

  baseline

Study Arms (2)

group A

ACTIVE COMPARATOR

60 patient with sever alopecia areata

Drug: Baricitinib Oral Tablet

group B

PLACEBO COMPARATOR

60 healthy individuals

Drug: Baricitinib Oral Tablet

Interventions

Baricitinib Oral Tablet DRUG

Baricitinib 2/4mg giving to patients with sever alopecia areata after assessment Retinol Binding Protein 4 and its genetic variations.

group A; group B

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients at least 12 years old not more than 60 with severe alopecia areata, multiple or /with not responding to usual treatment

You may not qualify if:

• Patients with scarring alopecia.
• Patients less than 12 years old or more than 60.
• Patients with active inflammatory disease or immuncompromised.
• Patients with infection or malignancy .
• Patients with antiepileptic drugs or psychotics .
• Pregnancy and lactation .
• Patients with abnormal lipid profile.
• Patients with bleeding or thrombotic tendency.
• Patients taking other JAK inhibitors or cyclosporine or immunosuppressive drugs.
• Patients with active herpes zoster or have tendency for recurrence.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley University

Qina, الكيلو 6 Qena - Safaga Rd, Qena, Qena Governorate, +20963211279, Egypt

Location

Related Publications (6)

• King B, Ohyama M, Kwon O, Zlotogorski A, Ko J, Mesinkovska NA, Hordinsky M, Dutronc Y, Wu WS, McCollam J, Chiasserini C, Yu G, Stanley S, Holzwarth K, DeLozier AM, Sinclair R; BRAVE-AA Investigators. Two Phase 3 Trials of Baricitinib for Alopecia Areata. N Engl J Med. 2022 May 5;386(18):1687-1699. doi: 10.1056/NEJMoa2110343. Epub 2022 Mar 26.

  PMID: 35334197 BACKGROUND

• Steinhoff JS, Lass A, Schupp M. Biological Functions of RBP4 and Its Relevance for Human Diseases. Front Physiol. 2021 Mar 11;12:659977. doi: 10.3389/fphys.2021.659977. eCollection 2021.

  PMID: 33790810 BACKGROUND

• Al-Eitan LN, Alghamdi MA, Al Momani RO, Aljamal HA, Abdalla AM, Mohammed HM. Genetic predisposition of alopecia areata in jordanians: A case-control study. Heliyon. 2022 Mar 24;8(4):e09184. doi: 10.1016/j.heliyon.2022.e09184. eCollection 2022 Apr.

  PMID: 35392398 BACKGROUND

• Bhardwaj P, Basu D, Podder I, Gharami RC. Clinico-Epidemiological Profile of Childhood Alopecia Areata Along with Dermoscopic Correlation: A Cross-Section, Observational Study. Indian Dermatol Online J. 2021 Mar 2;12(2):250-257. doi: 10.4103/idoj.IDOJ_451_20. eCollection 2021 Mar-Apr.

  PMID: 33959521 BACKGROUND

• Gil-Quinones SR, Sepulveda-Pachon IT, Sanchez Vanegas G, Gutierrez-Castaneda LD. Effect of PTPN22, FAS/FASL, IL2RA and CTLA4 genetic polymorphisms on the risk of developing alopecia areata: A systematic review of the literature and meta-analysis. PLoS One. 2021 Nov 4;16(11):e0258499. doi: 10.1371/journal.pone.0258499. eCollection 2021.

  PMID: 34735462 BACKGROUND

• Pratt CH, King LE Jr, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017 Mar 16;3:17011. doi: 10.1038/nrdp.2017.11.

  PMID: 28300084 BACKGROUND

MeSH Terms

Conditions

Alopecia Areata

Interventions

baricitinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Mostafa Adam Ali El Tieb, professor

  Aswan University

  STUDY DIRECTOR

• Mohamed Hosny Hassan, professor

  South Valley University

  STUDY DIRECTOR

• Eisa Mohammed Hegazy, professor

  South Valley University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: asses level of retinol binding protein 4 before and after barcitinib treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: September 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: October 30, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

EG (1)