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Acne VulgarisEarly Phase 1NCT02620813

De Novo Lipogenesis of Sebaceous Glands in Acne

A Early Phase 1 study testing Tretinoin and Isotretinoin in people with Acne Vulgaris, run by University of California, Davis at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 15 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Acne Vulgaris
What is being tested?
Tretinoin and Isotretinoin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesUnited States
Study dates
Oct 2015to 12 Oct 2017
Phase
Early Phase 1
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 15 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Dermatology Research Area

    Davis, California, 95616

  • UC Davis Department of Dermatology

    Sacramento, California, 95816

Other trials in United States

About this study

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.
Read the 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.

Conditions
Acne Vulgaris
Being tested
Tretinoin, Isotretinoin
Keywords
acne, sebaceous gland, lipid, sebum
Medical subject headings
Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TretinoinDrug

    Also called Retin-A

    Subjects will apply 0.5% tretinoin cream nightly to their face for a total of 12 weeks.

  • IsotretinoinDrug

    Subjects will take isotretinoin as prescribed by their dermatologist.

Study groups in NCT02620813
Study groupRoleWhat they receive
No AcneNo interventionHealthy subjects without acne between the ages of 15-45
Acne Subjects on Topical Tretinoin TreatmentExperimentalSubjects with acne before and after topical retinoid therapy
Receives: Drug: Tretinoin
Acne Subjects on Systemic Isotretinoin TreatmentExperimentalSubjects with acne before and after isotretinoin therapy
Receives: Drug: Isotretinoin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sebumeter measurement differences before and after treatment with isotretinoin

    Measured: 3 months

  2. 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.

    Measured: 3 months

Secondary outcomes (5)

  1. Change in the global acne grade score

    Measured: 3 months

  2. Change in the investigator global assessment of acne

    Measured: 3 months

  3. Change in the lesion counts of inflammatory and non-inflammatory lesions.

    Measured: 3 months

  4. Difference in the fractional contribution of de novo lipogenesis (DNL) to the sebum total palmitate between those with and without acne

    Measured: 3 months

  5. Difference in the fractional contribution of DNL to the sebum total palmitate before and after treatment with a topical retinoid (adapalene, tazarotene, or tretinoin).

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2015 (estimated)
  2. Study startOct 2015
  3. Primary completion12 Oct 2017
  4. Study completion12 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02620813
Sponsor's protocol ID
725019
Status last verified
Aug 2021
First submitted
1 Dec 2015
Last updated
5 Aug 2021
Results posted
No

Publications

  • 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.

    PubMed 20734057

  • 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.

    PubMed 8369207

  • 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.

    PubMed 18474083

  • 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.

    PubMed 2648418

  • 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.

    PubMed 20436883

  • 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.

    PubMed 24523159

  • 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.

    PubMed 24301232

  • 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.

    PubMed 19282842

  • 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.

    PubMed 11701705

  • 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.

    PubMed 18447941

  • 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.

    PubMed 22552026

  • 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.

    PubMed 12941759

  • 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.

    PubMed 21862086

  • 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.

    PubMed 16505497

  • 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.

    PubMed 20682577

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Tretinoin and Isotretinoin in people with Acne Vulgaris, run by University of California, Davis at 2 sites in United States.

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 7 inclusion and 4 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: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sebumeter measurement differences before and after treatment with isotretinoin (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT02620813, which also lists 21 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 5 Aug 2021.

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