De Novo Lipogenesis of Sebaceous Glands in Acne

Acne Vulgaris Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620813
• Other study ID #: 725019
• Status: Completed
• Phase: Early Phase 1
• Start date: October 2015
• Est. completion date: October 12, 2017

Study information

• Verified date: August 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are two purposes of this study:

1. First, the investigators want to see what the differences are in de novo sebaceous lipid production of people with and without acne.

2. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 12, 2017
• Est. primary completion date: October 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Tretinoin
Subjects will apply 0.5% tretinoin cream nightly to their face for a total of 12 weeks.
• Isotretinoin
Subjects will take isotretinoin as prescribed by their dermatologist.

Locations

Country	Name	City	State
United States	Dermatology Research Area	Davis	California
United States	UC Davis Department of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (21)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Money KE, Myles WS. Heavy water nystagmus and effects of alcohol. Nature. 1974 Feb 8;247(5440):404-5. — View Citation

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. — View Citation

Pappas A, Johnsen S, Liu JC, Eisinger M. Sebum analysis of individuals with and without acne. Dermatoendocrinol. 2009 May;1(3):157-61. — View Citation

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. — View Citation

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. — View Citation

Thody AJ, Shuster S. Control and function of sebaceous glands. Physiol Rev. 1989 Apr;69(2):383-416. Review. — View Citation

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. — View Citation

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. — View Citation

Zouboulis CC, Baron JM, Böhm 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. Review. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sebumeter measurement differences before and after treatment with isotretinoin		3 months
Primary	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.		3 months
Secondary	Change in the global acne grade score		3 months
Secondary	Change in the investigator global assessment of acne		3 months
Secondary	Change in the lesion counts of inflammatory and non-inflammatory lesions.		3 months
Secondary	Difference in the fractional contribution of de novo lipogenesis (DNL) to the sebum total palmitate between those with and without acne		3 months
Secondary	Difference in the fractional contribution of DNL to the sebum total palmitate before and after treatment with a topical retinoid (adapalene, tazarotene, or tretinoin).		3 months