Acne VulgarisNCT03480503
Apelin12 in Acne Vulgaris
An observational study of Acne Vulgaris, run by Assiut University.
Trial summary
Acne vulgaris is a common chronic inflammatory disease of the pilosebaceous unit which is characterized by the formation of non-inflammatory open and closed comedones and inflammatory papules, pustules, nodules and cysts. It is a multifactorial disease that affects mostly adolescent population. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- May 2018to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will be performed at Department of Dermatology, Venereology and Andrology in Assiut University Hospital.
Who may be able to join
- Acne vulgaris patients from different ages and sex.
Who cannot join
- Pregnant and lactating females.
- Local cutaneous infection or any other dermatological diseases.
- Diabetic patients or severe systemic disease such as liver and renal failure.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Serum apelin12 in Acne Vulgaris
Acne vulgaris is a common chronic inflammatory disease of the pilosebaceous unit which is characterized by the formation of non-inflammatory open and closed comedones and inflammatory papules, pustules, nodules and cysts.
It is a multifactorial disease that affects mostly adolescent population. Acne appears very early in puberty during the preteen years, often before menarche in girls. Because many adolescents have acne, it is difficult to predict which individuals are prone to severe cases.
The pathogenesis of acne is complex, with strong evidence supporting the involvement of follicular hyperkeratinization, hyperactivity of the sebaceous glands, colonization of Propionibacterium acnes and yeast, and inflammation. Although the importance of androgens in the pathophysiology of acne has been supported by both clinical studies and experimental data, the research evaluating adipokines are very few in patients with acne vulgaris.
Read the detailed description
Acne lesions may vary in number during the natural course of the disease and multiple measurements have been developed which is based on clinical examination and photographic documentation, to measure the clinical severity.
The Grading of acne based on the type of lesions, affected surface area and their severity that can help in deciding which therapies are needed in each individual. However, no grading system has been accepted universally. The Global Acne Grading System is a quantitative scoring system to assess the severity of acne. According to this score acne was graded as mild, moderate, severe and very severe.
The severity of acne was also graded using the Comprehensive Acne Severity Scale.
Adipokines are proteins that are synthesized and secreted primarily by adipocytes in response to various stimuli, include interleukin 6 and other small molecular weight bioactive proteins such as adiponectin, resistin, leptin, serpin E1 [also known as plasminogen activator inhibitor 1 and endothelial plasminogen activator inhibitor], visfatin (also known as nicotinamide phosphoribosyltransferase), apelin, chemerin, retinol binding protein 4, and monocyte chemoattractant protein 1.
Due to their different biological properties and diverse cellular targets adipokines are involved in a wide array of (patho)physiological processes and are responsible for mediating the inflammatory effects of the adipose tissue in the local tissue environment as well as to different organs via circulation. By detecting alterations in their serum levels also in dermatological diseases such as acne vulgaris and psoriasis, extensive studies have also started in dermatological research to identify the possible targets and the cutaneous sources of these proteins.
Apelin is an endogenous ligand of the previously discovered "orphan" receptor named APJ, isolated from bovine stomach extracts.
It is a product of apelin gene that is located on chromosome Xq25-26.1 and translated as a 77 amino acid prepropeptide. It is processed into several active molecular forms with different biological activities. Apelin belongs to adipokines group because its m-RNA expression has been demonstrated in mature adipocytes in rodents and humans.
Apelin peptide expression has been also demonstrated in several tissues and seems to have different regulatory functions, depending on the expressing tissue, the apelinergic system distribution over such a variety of tissues has suggested that it might play relevant roles in human physiology.
Apelin has been reported to have an effect on appetite, drinking behavior, angiogenesis, and the cardiovascular system. It is regulated by insulin. Apelin might be a novel target for preventing obesity and obesity-related diseases via enhancement of vascular integrity.
Several active apelin forms exist such as apelin-36, apelin-17, apelin-13, and apelin-12.
Apelin-12 is a 12-amino peptide fragment that has been implicated in reducing blood pressure via a nitric oxide mechanism, and is involved in feeding mechanisms via stimulation of cholecystokinin secretion.
It is considered to be one of the most potent isoform of apelin.
The studies evaluating the role of adipokines are very few in patient with acne vulgaris.
- Conditions
- Acne Vulgaris
- Keywords
- Apelin12
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | Patients with acne vulgaris , measurement of serum apelin12 by using ELISA technique ,complete lipid profile and fasting blood glucose. | |
| Control group | Healthy control volunteers, measurement of serum apelin12 by using ELISA technique ,complete lipid profile and fasting blood glucose. |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum apelin12
blood samples will be taken then measurement of serum apelin12 by using ELISA technique after fasting 12 hours.
Measured: 12 hour
Secondary outcomes (2)
Complete lipid profile.
blood samples will be taken and complete lipid profile will be measured after fasting 12 hours by biochemical measurement.
Measured: 12hour
Fasting blood glucose
blood samples will be taken and fasting blood glucose level will be measured after fasting 7 hours by biochemical measurement method.
Measured: 7hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study startMay 2018 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Abdelaziz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480503
- Sponsor's protocol ID
- SAAA
- Status last verified
- Mar 2018
- First submitted
- 21 Mar 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Boucher J, Masri B, Daviaud D, Gesta S, Guigne C, Mazzucotelli A, Castan-Laurell I, Tack I, Knibiehler B, Carpene C, Audigier Y, Saulnier-Blache JS, Valet P. Apelin, a newly identified adipokine up-regulated by insulin and obesity. Endocrinology. 2005 Apr;146(4):1764-71. doi: 10.1210/en.2004-1427. Epub 2005 Jan 27.
PubMed 15677759Carpene C, Dray C, Attane C, Valet P, Portillo MP, Churruca I, Milagro FI, Castan-Laurell I. Expanding role for the apelin/APJ system in physiopathology. J Physiol Biochem. 2007 Dec;63(4):359-73.
PubMed 18457011Cordain L, Lindeberg S, Hurtado M, Hill K, Eaton SB, Brand-Miller J. Acne vulgaris: a disease of Western civilization. Arch Dermatol. 2002 Dec;138(12):1584-90. doi: 10.1001/archderm.138.12.1584.
PubMed 12472346Cox CM, D'Agostino SL, Miller MK, Heimark RL, Krieg PA. Apelin, the ligand for the endothelial G-protein-coupled receptor, APJ, is a potent angiogenic factor required for normal vascular development of the frog embryo. Dev Biol. 2006 Aug 1;296(1):177-89. doi: 10.1016/j.ydbio.2006.04.452. Epub 2006 Apr 27.
PubMed 16750822De Falco M, De Luca L, Onori N, Cavallotti I, Artigiano F, Esposito V, De Luca B, Laforgia V, Groeger AM, De Luca A. Apelin expression in normal human tissues. In Vivo. 2002 Sep-Oct;16(5):333-6.
PubMed 12494873Doshi A, Zaheer A, Stiller MJ. A comparison of current acne grading systems and proposal of a novel system. Int J Dermatol. 1997 Jun;36(6):416-8. doi: 10.1046/j.1365-4362.1997.00099.x. No abstract available.
PubMed 9248884Farkasfalvi K, Stagg MA, Coppen SR, Siedlecka U, Lee J, Soppa GK, Marczin N, Szokodi I, Yacoub MH, Terracciano CM. Direct effects of apelin on cardiomyocyte contractility and electrophysiology. Biochem Biophys Res Commun. 2007 Jun 15;357(4):889-95. doi: 10.1016/j.bbrc.2007.04.017. Epub 2007 Apr 12.
PubMed 17466269Gerdes S, Rostami-Yazdi M, Mrowietz U. Adipokines and psoriasis. Exp Dermatol. 2011 Feb;20(2):81-7. doi: 10.1111/j.1600-0625.2010.01210.x.
PubMed 21255085Kawamata Y, Habata Y, Fukusumi S, Hosoya M, Fujii R, Hinuma S, Nishizawa N, Kitada C, Onda H, Nishimura O, Fujino M. Molecular properties of apelin: tissue distribution and receptor binding. Biochim Biophys Acta. 2001 Apr 23;1538(2-3):162-71. doi: 10.1016/s0167-4889(00)00143-9.
PubMed 11336787Kitabchi AE, Imseis RE, Bush AJ, Williams-Cleaves B, Pourmotabbed G. Racial differences in the correlation between gonadal androgens and serum insulin levels. Diabetes Care. 1999 Sep;22(9):1524-9. doi: 10.2337/diacare.22.9.1524.
PubMed 10480520Lee DK, Cheng R, Nguyen T, Fan T, Kariyawasam AP, Liu Y, Osmond DH, George SR, O'Dowd BF. Characterization of apelin, the ligand for the APJ receptor. J Neurochem. 2000 Jan;74(1):34-41. doi: 10.1046/j.1471-4159.2000.0740034.x.
PubMed 10617103Lehmann HP, Robinson KA, Andrews JS, Holloway V, Goodman SN. Acne therapy: a methodologic review. J Am Acad Dermatol. 2002 Aug;47(2):231-40. doi: 10.1067/mjd.2002.120912.
PubMed 12140469Liang T, Hoyer S, Yu R, Soltani K, Lorincz AL, Hiipakka RA, Liao S. Immunocytochemical localization of androgen receptors in human skin using monoclonal antibodies against the androgen receptor. J Invest Dermatol. 1993 May;100(5):663-6. doi: 10.1111/1523-1747.ep12472330.
PubMed 7684056Mesmin C, Fenaille F, Becher F, Tabet JC, Ezan E. Identification and characterization of apelin peptides in bovine colostrum and milk by liquid chromatography-mass spectrometry. J Proteome Res. 2011 Nov 4;10(11):5222-31. doi: 10.1021/pr200725x. Epub 2011 Oct 13.
PubMed 21939284Najafipour H, Soltani Hekmat A, Nekooian AA, Esmaeili-Mahani S. Apelin receptor expression in ischemic and non- ischemic kidneys and cardiovascular responses to apelin in chronic two-kidney-one-clip hypertension in rats. Regul Pept. 2012 Oct 10;178(1-3):43-50. doi: 10.1016/j.regpep.2012.06.006. Epub 2012 Jul 14.
PubMed 22796316
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum apelin12 in Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03480503
- Acronym / sponsor ID
- SAAA
- Conditions
- Acne Vulgaris
- Keywords
- Apelin12
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acne vulgaris is a common chronic inflammatory disease of the pilosebaceous unit which is characterized by the formation of non-inflammatory open and closed comedones and inflammatory papules, pustules, nodules and cysts.
It is a multifactorial disease that affects mostly adolescent population. Acne appears very early in puberty during the preteen years, often before menarche in girls. Because many adolescents have acne, it is difficult to predict which individuals are prone to severe cases.
The pathogenesis of acne is complex, with strong evidence supporting the involvement of follicular hyperkeratinization, hyperactivity of the sebaceous glands, colonization of Propionibacterium acnes and yeast, and inflammation. Although the importance of androgens in the pathophysiology of acne has been supported by both clinical studies and experimental data, the research evaluating adipokines are very few in patients with acne vulgaris.
Detailed description
Acne lesions may vary in number during the natural course of the disease and multiple measurements have been developed which is based on clinical examination and photographic documentation, to measure the clinical severity.
The Grading of acne based on the type of lesions, affected surface area and their severity that can help in deciding which therapies are needed in each individual. However, no grading system has been accepted universally. The Global Acne Grading System is a quantitative scoring system to assess the severity of acne. According to this score acne was graded as mild, moderate, severe and very severe.
The severity of acne was also graded using the Comprehensive Acne Severity Scale.
Adipokines are proteins that are synthesized and secreted primarily by adipocytes in response to various stimuli, include interleukin 6 and other small molecular weight bioactive proteins such as adiponectin, resistin, leptin, serpin E1 [also known as plasminogen activator inhibitor 1 and endothelial plasminogen activator inhibitor], visfatin (also known as nicotinamide phosphoribosyltransferase), apelin, chemerin, retinol binding protein 4, and monocyte chemoattractant protein 1.
Due to their different biological properties and diverse cellular targets adipokines are involved in a wide array of (patho)physiological processes and are responsible for mediating the inflammatory effects of the adipose tissue in the local tissue environment as well as to different organs via circulation. By detecting alterations in their serum levels also in dermatological diseases such as acne vulgaris and psoriasis, extensive studies have also started in dermatological research to identify the possible targets and the cutaneous sources of these proteins.
Apelin is an endogenous ligand of the previously discovered "orphan" receptor named APJ, isolated from bovine stomach extracts.
It is a product of apelin gene that is located on chromosome Xq25-26.1 and translated as a 77 amino acid prepropeptide. It is processed into several active molecular forms with different biological activities. Apelin belongs to adipokines group because its m-RNA expression has been demonstrated in mature adipocytes in rodents and humans.
Apelin peptide expression has been also demonstrated in several tissues and seems to have different regulatory functions, depending on the expressing tissue, the apelinergic system distribution over such a variety of tissues has suggested that it might play relevant roles in human physiology.
Apelin has been reported to have an effect on appetite, drinking behavior, angiogenesis, and the cardiovascular system. It is regulated by insulin. Apelin might be a novel target for preventing obesity and obesity-related diseases via enhancement of vascular integrity.
Several active apelin forms exist such as apelin-36, apelin-17, apelin-13, and apelin-12.
Apelin-12 is a 12-amino peptide fragment that has been implicated in reducing blood pressure via a nitric oxide mechanism, and is involved in feeding mechanisms via stimulation of cholecystokinin secretion.
It is considered to be one of the most potent isoform of apelin.
The studies evaluating the role of adipokines are very few in patient with acne vulgaris.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | –Patients with acne vulgaris , measurement of serum apelin12 by using ELISA technique ,complete lipid profile and fasting blood glucose. |
| Control group | – | –Healthy control volunteers, measurement of serum apelin12 by using ELISA technique ,complete lipid profile and fasting blood glucose. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be performed at Department of Dermatology, Venereology and Andrology in Assiut University Hospital.
Key inclusion criteria (1 listed)
- Acne vulgaris patients from different ages and sex.
Key exclusion criteria (3 listed)
- Pregnant and lactating females.
- Local cutaneous infection or any other dermatological diseases.
- Diabetic patients or severe systemic disease such as liver and renal failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serum apelin12
Time frame: 12 hour
blood samples will be taken then measurement of serum apelin12 by using ELISA technique after fasting 12 hours.
2 secondary outcomes
Complete lipid profile.
Time frame: 12hour
Fasting blood glucose
Time frame: 7hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Background: PubMed 15677759Boucher J, Masri B, Daviaud D, Gesta S, Guigne C, Mazzucotelli A, Castan-Laurell I, Tack I, Knibiehler B, Carpene C, Audigier Y, Saulnier-Blache JS, Valet P. Apelin, a newly identified adipokine up-regulated by insulin and obesity. Endocrinology. 2005 Apr;146(4):1764-71. doi: 10.1210/en.2004-1427. Epub 2005 Jan 27.
- Background: PubMed 18457011Carpene C, Dray C, Attane C, Valet P, Portillo MP, Churruca I, Milagro FI, Castan-Laurell I. Expanding role for the apelin/APJ system in physiopathology. J Physiol Biochem. 2007 Dec;63(4):359-73.
- Background: PubMed 12472346Cordain L, Lindeberg S, Hurtado M, Hill K, Eaton SB, Brand-Miller J. Acne vulgaris: a disease of Western civilization. Arch Dermatol. 2002 Dec;138(12):1584-90. doi: 10.1001/archderm.138.12.1584.
- Background: PubMed 16750822Cox CM, D'Agostino SL, Miller MK, Heimark RL, Krieg PA. Apelin, the ligand for the endothelial G-protein-coupled receptor, APJ, is a potent angiogenic factor required for normal vascular development of the frog embryo. Dev Biol. 2006 Aug 1;296(1):177-89. doi: 10.1016/j.ydbio.2006.04.452. Epub 2006 Apr 27.
- Background: PubMed 12494873De Falco M, De Luca L, Onori N, Cavallotti I, Artigiano F, Esposito V, De Luca B, Laforgia V, Groeger AM, De Luca A. Apelin expression in normal human tissues. In Vivo. 2002 Sep-Oct;16(5):333-6.
- Background: PubMed 9248884Doshi A, Zaheer A, Stiller MJ. A comparison of current acne grading systems and proposal of a novel system. Int J Dermatol. 1997 Jun;36(6):416-8. doi: 10.1046/j.1365-4362.1997.00099.x. No abstract available.
- Background: PubMed 17466269Farkasfalvi K, Stagg MA, Coppen SR, Siedlecka U, Lee J, Soppa GK, Marczin N, Szokodi I, Yacoub MH, Terracciano CM. Direct effects of apelin on cardiomyocyte contractility and electrophysiology. Biochem Biophys Res Commun. 2007 Jun 15;357(4):889-95. doi: 10.1016/j.bbrc.2007.04.017. Epub 2007 Apr 12.
- Background: PubMed 21255085Gerdes S, Rostami-Yazdi M, Mrowietz U. Adipokines and psoriasis. Exp Dermatol. 2011 Feb;20(2):81-7. doi: 10.1111/j.1600-0625.2010.01210.x.
- Background: PubMed 11336787Kawamata Y, Habata Y, Fukusumi S, Hosoya M, Fujii R, Hinuma S, Nishizawa N, Kitada C, Onda H, Nishimura O, Fujino M. Molecular properties of apelin: tissue distribution and receptor binding. Biochim Biophys Acta. 2001 Apr 23;1538(2-3):162-71. doi: 10.1016/s0167-4889(00)00143-9.
- Background: PubMed 10480520Kitabchi AE, Imseis RE, Bush AJ, Williams-Cleaves B, Pourmotabbed G. Racial differences in the correlation between gonadal androgens and serum insulin levels. Diabetes Care. 1999 Sep;22(9):1524-9. doi: 10.2337/diacare.22.9.1524.
- Background: PubMed 10617103Lee DK, Cheng R, Nguyen T, Fan T, Kariyawasam AP, Liu Y, Osmond DH, George SR, O'Dowd BF. Characterization of apelin, the ligand for the APJ receptor. J Neurochem. 2000 Jan;74(1):34-41. doi: 10.1046/j.1471-4159.2000.0740034.x.
- Background: PubMed 12140469Lehmann HP, Robinson KA, Andrews JS, Holloway V, Goodman SN. Acne therapy: a methodologic review. J Am Acad Dermatol. 2002 Aug;47(2):231-40. doi: 10.1067/mjd.2002.120912.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doaa Abu taleb, lecturer (01001463937, Dodda_aboutaleb@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum apelin12 (time frame: 12 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03480503, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.