Cutaneous JAK in Vitiligo and Acne Vulgaris.
Cutaneous JAK Expression in Vitiligo and Acne Vulgaris.
1 other identifier
observational
60
0 countries
N/A
Brief Summary
The Janus kinase/signal transducer and activator of transcription (JAK-STAT) cytokine signaling pathway is an emerging area of interest in dermatology, and emerging evidence suggests that this pathway may play a crucial role in pathogenesis of inflammatory skin disorders. Recent advances on the role of cytokines in the pathophysiology of immune mediated inflammatory diseases lead to the understanding that many pro inflammatory interleukins use JAK/STAT components for signal transduction .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2017
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJune 14, 2017
June 1, 2017
1 year
June 11, 2017
June 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
To analyze the cutaneous JAK expression in vitiligo and acne vulgaris, assess cutaneous JAK expression in relation to disease severity in vitiligo and acne vulgaris compared to controls
Skin biopsies will be taken from lesional and non-lesional skin of patients as well as from healthy volunteers as controls. All biopsies will be derived from untreated skin lesions for a minimum of 15 days before the biopsy The biopsies will be fixed and paraffin embedded. Five micron thick sections will be cut from paraffin blocks for immunohistochemical staining using specific antibodies for detection of expression of JAK1, JAK2 and JAK3. Additionally, biopsies will be preserved in RNA later solution at -20°C. RNA isolation and real-time qPCR analysis will be performed for measurement of cutaneous JAK1, JAK2 and JAK3 gene expression.
1 year
Study Arms (3)
patients with acne vulgaris
Clinical evaluation including full history taking and dermatological examination will be done for all patients. Assessment of disease severity will be performed using Global acne severity grading for acne vulgaris Skin biopsies will be taken from lesional and non-lesional skin .immunohistochemical staining using specific antibodies for detection of expression of JAK1, JAK2 and JAK3.
patients with vitiligo
Clinical evaluation including full history taking and dermatological examination will be done . Assessment of disease severity will be performed using VASI score Skin biopsies will be taken from lesional and non-lesional skin .immunohistochemical staining using specific antibodies for detection of expression of JAK1, JAK2 and JAK3..
control
Skin biopsies will be taken from skin of controls. . Five micron thick sections will be cut from paraffin blocks for immunohistochemical staining using specific antibodies for detection of expression of JAK1, JAK2 and JAK3.
Interventions
Clinical evaluation including full history taking and dermatological examination will be done for all patients. Assessment of disease severity will be performed using VASI score for vitiligo and Global acne severity grading for acne vulgaris Skin biopsies will be taken from lesional and non-lesional skin of patients as well as controls. immunohistochemical staining using specific antibodies for detection of expression of JAK1, JAK2 and JAK3. Additionally, biopsies will be preserved in RNA later solution at -20°C. RNA isolation and real-time qPCR analysis will be performed for measurement of cutaneous JAK1, JAK2 and JAK3 gene expression.
Eligibility Criteria
A group of 20 patients with vitiligo and 20 patients with acne vulgaris and another control group of 20 age and sex matched healthy volunteers.
You may qualify if:
- patients with vitiligo and acne vulgaris.
You may not qualify if:
- patients below 12 years of age, or receiving systemic treatments in the last month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (11)
Palanivel JA, Macbeth AE, Chetty NC, Levell NJ. An insight into JAK-STAT signalling in dermatology. Clin Exp Dermatol. 2014 Jun;39(4):513-8. doi: 10.1111/ced.12273.
PMID: 24825142BACKGROUNDO'Shea JJ, Murray PJ. Cytokine signaling modules in inflammatory responses. Immunity. 2008 Apr;28(4):477-87. doi: 10.1016/j.immuni.2008.03.002.
PMID: 18400190BACKGROUNDAlves de Medeiros AK, Speeckaert R, Desmet E, Van Gele M, De Schepper S, Lambert J. JAK3 as an Emerging Target for Topical Treatment of Inflammatory Skin Diseases. PLoS One. 2016 Oct 6;11(10):e0164080. doi: 10.1371/journal.pone.0164080. eCollection 2016.
PMID: 27711196BACKGROUNDRawlings JS, Rosler KM, Harrison DA. The JAK/STAT signaling pathway. J Cell Sci. 2004 Mar 15;117(Pt 8):1281-3. doi: 10.1242/jcs.00963. No abstract available.
PMID: 15020666BACKGROUNDO'Shea JJ, Schwartz DM, Villarino AV, Gadina M, McInnes IB, Laurence A. The JAK-STAT pathway: impact on human disease and therapeutic intervention. Annu Rev Med. 2015;66:311-28. doi: 10.1146/annurev-med-051113-024537.
PMID: 25587654BACKGROUNDDamsky W, King BA. JAK inhibitors in dermatology: The promise of a new drug class. J Am Acad Dermatol. 2017 Apr;76(4):736-744. doi: 10.1016/j.jaad.2016.12.005. Epub 2017 Jan 28.
PMID: 28139263BACKGROUNDPapp KA, Menter A, Strober B, Langley RG, Buonanno M, Wolk R, Gupta P, Krishnaswami S, Tan H, Harness JA. Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: a Phase 2b randomized placebo-controlled dose-ranging study. Br J Dermatol. 2012 Sep;167(3):668-77. doi: 10.1111/j.1365-2133.2012.11168.x.
PMID: 22924949BACKGROUNDPorts WC, Khan S, Lan S, Lamba M, Bolduc C, Bissonnette R, Papp K. A randomized phase 2a efficacy and safety trial of the topical Janus kinase inhibitor tofacitinib in the treatment of chronic plaque psoriasis. Br J Dermatol. 2013 Jul;169(1):137-45. doi: 10.1111/bjd.12266.
PMID: 23387374BACKGROUNDCraiglow BG, King BA. Tofacitinib Citrate for the Treatment of Vitiligo: A Pathogenesis-Directed Therapy. JAMA Dermatol. 2015 Oct;151(10):1110-2. doi: 10.1001/jamadermatol.2015.1520.
PMID: 26107994BACKGROUNDChoi JJ, Park MY, Lee HJ, Yoon DY, Lim Y, Hyun JW, Zouboulis CC, Jin M. TNF-alpha increases lipogenesis via JNK and PI3K/Akt pathways in SZ95 human sebocytes. J Dermatol Sci. 2012 Mar;65(3):179-88. doi: 10.1016/j.jdermsci.2011.11.005. Epub 2011 Nov 20.
PMID: 22305016BACKGROUNDAbdel Motaleb AA, Tawfik YM, El-Mokhtar MA, Elkady S, El-Gazzar AF, ElSayed SK, Awad SM. Cutaneous JAK Expression in Vitiligo. J Cutan Med Surg. 2021 Mar-Apr;25(2):157-162. doi: 10.1177/1203475420972340. Epub 2020 Nov 11.
PMID: 33174479DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amira Abdel Motaleb, MD
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
June 11, 2017
First Posted
June 14, 2017
Study Start
January 1, 2018
Primary Completion
January 1, 2019
Study Completion
June 1, 2019
Last Updated
June 14, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share