Polymorphism of Extrapituitary Promoter of PRL Gene and Relationships With Serum Prolactin Levels in Acne Vulgaris.
1 other identifier
observational
200
0 countries
N/A
Brief Summary
Acne vulgaris is one of the most common skin diseases. It is a disease of the pilosebaceous units, clinically characterized by seborrhea, comedones, papules, pustules, nodules and, in some cases, scarring.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
Started Jan 2018
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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 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
polymorphism of extrapituitary promoter of PRL gene in acne cases and controls
The blood samples are taken in the morning hours, between 08:00 and 10:00 am The genomic DNA from peripheral leukocytes is extracted. Genotyping of 1149G/T single nucleotide polymorphism (SNP) PRL extrapituitary promoter is done in acne patients and healthy individuals (control group) using PCR-RFLP method. The genomic DNA from peripheral leukocytes is extracted. Genotyping of 1149G/T single nucleotide polymorphism (SNP) PRL extrapituitary promoter is done in acne patients and healthy individuals (control group) using PCR-RFLP method.
1 year
Secondary Outcomes (1)
serum prolactin levels in acne patients and controls and among different acne severity grades
1 year
Study Arms (2)
cases with acne vulgaris
A group of 100 patients with acne vulgaris. blood sample are taken in the morning hours, between 08:00 and 10:00 am.
control group
control group of 100 age and sex matched healthy volunteers. blood sample are taken in the morning hours, between 08:00 and 10:00 am.
Interventions
Serum PRL levels are measured using ELISA assay kit in both groups and correlated with severity of acne in acne group. The genomic DNA from peripheral leukocytes is extracted. Genotyping of 1149G/T single nucleotide polymorphism (SNP) PRL extrapituitary promoter is done in acne patients and healthy individuals (control group) using PCR-RFLP method.
Eligibility Criteria
A group of 100 patients with acne vulgaris and another control group of 100 age and sex matched healthy volunteers
You may not qualify if:
- patients below 12 years of age
- patients recieving disorders and drug that could alter levels of prolactin such as thyroid disorders, renal and/or hepatic failure and drug use.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (8)
Zouboulis CC, Eady A, Philpott M, Goldsmith LA, Orfanos C, Cunliffe WC, Rosenfield R. What is the pathogenesis of acne? Exp Dermatol. 2005 Feb;14(2):143-52. doi: 10.1111/j.0906-6705.2005.0285a.x.
PMID: 15679586BACKGROUNDGanceviciene R, Graziene V, Bohm M, Zouboulis CC. Increased in situ expression of melanocortin-1 receptor in sebaceous glands of lesional skin of patients with acne vulgaris. Exp Dermatol. 2007 Jul;16(7):547-52. doi: 10.1111/j.1600-0625.2007.00565.x.
PMID: 17576233BACKGROUNDArck PC, Slominski A, Theoharides TC, Peters EM, Paus R. Neuroimmunology of stress: skin takes center stage. J Invest Dermatol. 2006 Aug;126(8):1697-704. doi: 10.1038/sj.jid.5700104.
PMID: 16845409BACKGROUNDOakes SR, Rogers RL, Naylor MJ, Ormandy CJ. Prolactin regulation of mammary gland development. J Mammary Gland Biol Neoplasia. 2008 Mar;13(1):13-28. doi: 10.1007/s10911-008-9069-5. Epub 2008 Jan 25.
PMID: 18219564BACKGROUNDZouboulis CC, Schagen S, Alestas T. The sebocyte culture: a model to study the pathophysiology of the sebaceous gland in sebostasis, seborrhoea and acne. Arch Dermatol Res. 2008 Sep;300(8):397-413. doi: 10.1007/s00403-008-0879-5. Epub 2008 Aug 9.
PMID: 18690467BACKGROUNDLangan EA, Ramot Y, Goffin V, Griffiths CE, Foitzik K, Paus R. Mind the (gender) gap: does prolactin exert gender and/or site-specific effects on the human hair follicle? J Invest Dermatol. 2010 Mar;130(3):886-91. doi: 10.1038/jid.2009.340. Epub 2009 Nov 5. No abstract available.
PMID: 19890346BACKGROUNDReem GH, Ray DW, Davis JR. The human prolactin gene upstream promoter is regulated in lymphoid cells by activators of T-cells and by cAMP. J Mol Endocrinol. 1999 Jun;22(3):285-92. doi: 10.1677/jme.0.0220285.
PMID: 10343287BACKGROUNDPaus R. Does prolactin play a role in skin biology and pathology? Med Hypotheses. 1991 Sep;36(1):33-42. doi: 10.1016/0306-9877(91)90161-q.
PMID: 1766412BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Awad, 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
- principal investigator
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