- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02620813
De Novo Lipogenesis of Sebaceous Glands in Acne
There are two purposes of this study:
- First, the investigators want to see what the differences are in de novo sebaceous lipid production of people with and without acne.
- Secondly, the investigators want to know what happens to sebaceous gland de novo lipid production before and after treatment with topical tretinoin and oral isotretinoin.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary objective of this study is to understand how de novo lipid production of sebaceous glands are altered in acne and with acne directed therapy.
Hypothesis 1: The overall de novo lipogenesis will be increased in those with acne
Hypothesis 2: Treatment with topical tretinoin and systemic isotretinoin will reduce de novo lipogenesis.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Davis, California, United States, 95616
- Dermatology Research Area
-
Sacramento, California, United States, 95816
- UC Davis Department of Dermatology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 15 to 45 years of age
- Subject/Parents/Legal Guardian be able to read and comprehend study procedure and consent forms
- Have acne that is diagnosed by a board certified dermatologist
Meet one of the following criteria:
- already been prescribed oral isotretinoin for treatment of acne
- have already been prescribed a topical retinoid
- eligible for prescription of topical tretinoin
Exclusion Criteria:
- Those who have already initiated or completed a course of systemic isotretinoin
- Those with seborrheic dermatitis, rosacea, or polycystic ovary syndrome
- Those who are pregnant in female participants
- Those who do not fit the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No Acne
Healthy subjects without acne between the ages of 15-45
|
|
Experimental: Acne Subjects on Topical Tretinoin Treatment
Subjects with acne before and after topical retinoid therapy
|
Subjects will apply 0.5% tretinoin cream nightly to their face for a total of 12 weeks.
Other Names:
|
Experimental: Acne Subjects on Systemic Isotretinoin Treatment
Subjects with acne before and after isotretinoin therapy
|
Subjects will take isotretinoin as prescribed by their dermatologist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sebumeter measurement differences before and after treatment with isotretinoin
Time Frame: 3 months
|
3 months
|
Change in the fractional contribution of DNL to the total sebum palmitate before and after treatment with isotretinoin at baseline and 3 months after treatment.
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the global acne grade score
Time Frame: 3 months
|
3 months
|
Change in the investigator global assessment of acne
Time Frame: 3 months
|
3 months
|
Change in the lesion counts of inflammatory and non-inflammatory lesions.
Time Frame: 3 months
|
3 months
|
Difference in the fractional contribution of de novo lipogenesis (DNL) to the sebum total palmitate between those with and without acne
Time Frame: 3 months
|
3 months
|
Difference in the fractional contribution of DNL to the sebum total palmitate before and after treatment with a topical retinoid (adapalene, tazarotene, or tretinoin).
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Doshi 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.
- Rush EC, Chhichhia P, Kilding AE, Plank LD. Water turnover in children and young adults. Eur J Appl Physiol. 2010 Dec;110(6):1209-14. doi: 10.1007/s00421-010-1621-5. Epub 2010 Aug 24.
- Blume U, Verschoore M, Poncet M, Czernielewski J, Orfanos CE, Schaefer H. The vellus hair follicle in acne: hair growth and sebum excretion. Br J Dermatol. 1993 Jul;129(1):23-7. doi: 10.1111/j.1365-2133.1993.tb03306.x.
- Zouboulis CC, Baron JM, Bohm M, Kippenberger S, Kurzen H, Reichrath J, Thielitz A. Frontiers in sebaceous gland biology and pathology. Exp Dermatol. 2008 Jun;17(6):542-51. doi: 10.1111/j.1600-0625.2008.00725.x.
- Thody AJ, Shuster S. Control and function of sebaceous glands. Physiol Rev. 1989 Apr;69(2):383-416. doi: 10.1152/physrev.1989.69.2.383.
- Pappas A, Johnsen S, Liu JC, Eisinger M. Sebum analysis of individuals with and without acne. Dermatoendocrinol. 2009 May;1(3):157-61. doi: 10.4161/derm.1.3.8473.
- Nakase K, Nakaminami H, Takenaka Y, Hayashi N, Kawashima M, Noguchi N. Relationship between the severity of acne vulgaris and antimicrobial resistance of bacteria isolated from acne lesions in a hospital in Japan. J Med Microbiol. 2014 May;63(Pt 5):721-728. doi: 10.1099/jmm.0.067611-0. Epub 2014 Feb 12.
- Thiboutot D, Dreno B, Gollnick H, Bettoli V, Kang S, Leyden JJ, Shalita A, Torres V; Global Alliance to Improve Outcomes in Acne. A call to limit antibiotic use in acne. J Drugs Dermatol. 2013 Dec;12(12):1331-2. No abstract available.
- Iinuma K, Sato T, Akimoto N, Noguchi N, Sasatsu M, Nishijima S, Kurokawa I, Ito A. Involvement of Propionibacterium acnes in the augmentation of lipogenesis in hamster sebaceous glands in vivo and in vitro. J Invest Dermatol. 2009 Sep;129(9):2113-9. doi: 10.1038/jid.2009.46. Epub 2009 Mar 12.
- Cachefo A, Boucher P, Vidon C, Dusserre E, Diraison F, Beylot M. Hepatic lipogenesis and cholesterol synthesis in hyperthyroid patients. J Clin Endocrinol Metab. 2001 Nov;86(11):5353-7. doi: 10.1210/jcem.86.11.7981.
- Kassis AN, Jones PJ. Changes in cholesterol kinetics following sugar cane policosanol supplementation: a randomized control trial. Lipids Health Dis. 2008 Apr 30;7:17. doi: 10.1186/1476-511X-7-17.
- Wulan SN, Westerterp KR, Plasqui G. Dietary and 24-h fat oxidation in Asians and whites who differ in body composition. Am J Clin Nutr. 2012 Jun;95(6):1335-41. doi: 10.3945/ajcn.111.031369. Epub 2012 May 2.
- Adkins A, Basu R, Persson M, Dicke B, Shah P, Vella A, Schwenk WF, Rizza R. Higher insulin concentrations are required to suppress gluconeogenesis than glycogenolysis in nondiabetic humans. Diabetes. 2003 Sep;52(9):2213-20. doi: 10.2337/diabetes.52.9.2213.
- Barosa C, Silva C, Fagulha A, Barros L, Caldeira MM, Carvalheiro M, Jones JG. Sources of hepatic glycogen synthesis following a milk-containing breakfast meal in healthy subjects. Metabolism. 2012 Feb;61(2):250-4. doi: 10.1016/j.metabol.2011.06.022. Epub 2011 Sep 8.
- Basu A, Jensen MD, McCann F, Mukhopadhyay D, Joyner MJ, Rizza RA. Effects of pioglitazone versus glipizide on body fat distribution, body water content, and hemodynamics in type 2 diabetes. Diabetes Care. 2006 Mar;29(3):510-4. doi: 10.2337/diacare.29.03.06.dc05-2004.
- Chacko SK, Sunehag AL. Gluconeogenesis continues in premature infants receiving total parenteral nutrition. Arch Dis Child Fetal Neonatal Ed. 2010 Nov;95(6):F413-8. doi: 10.1136/adc.2009.178020. Epub 2010 Aug 3.
- Kao CC, Hsu JW, Bandi V, Hanania NA, Kheradmand F, Jahoor F. Resting energy expenditure and protein turnover are increased in patients with severe chronic obstructive pulmonary disease. Metabolism. 2011 Oct;60(10):1449-55. doi: 10.1016/j.metabol.2011.02.013. Epub 2011 May 6.
- Letexier D, Diraison F, Beylot M. Addition of inulin to a moderately high-carbohydrate diet reduces hepatic lipogenesis and plasma triacylglycerol concentrations in humans. Am J Clin Nutr. 2003 Mar;77(3):559-64. doi: 10.1093/ajcn/77.3.559.
- Money KE, Myles WS. Heavy water nystagmus and effects of alcohol. Nature. 1974 Feb 8;247(5440):404-5. doi: 10.1038/247404a0. No abstract available.
- Browning JD, Burgess SC. Use of (2)H(2)O for estimating rates of gluconeogenesis: determination and correction of error due to transaldolase exchange. Am J Physiol Endocrinol Metab. 2012 Dec 1;303(11):E1304-12. doi: 10.1152/ajpendo.00306.2012. Epub 2012 Oct 2.
- Vrisekoop N, den Braber I, de Boer AB, Ruiter AF, Ackermans MT, van der Crabben SN, Schrijver EH, Spierenburg G, Sauerwein HP, Hazenberg MD, de Boer RJ, Miedema F, Borghans JA, Tesselaar K. Sparse production but preferential incorporation of recently produced naive T cells in the human peripheral pool. Proc Natl Acad Sci U S A. 2008 Apr 22;105(16):6115-20. doi: 10.1073/pnas.0709713105. Epub 2008 Apr 17.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 725019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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