The Lipid Profile of the Skin Surface in Acne

NCT02180425 | Completed

• 1 other identifier: 531506
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the differences in the skin lipid profile of patients with and without acne. Secondly, the goal is to learn more about what the effects of retinoinds (topical and systemic) are on the the skin lipid profile. We hypothesize that the skin lipid profile of subjects with acne will be lower in inflammatory lipids in comparison to subjects without acne.

Conditions

Acne

Keywords

acne; lipid; tretinoin; isotretinoin

Outcome Measures

Primary Outcomes (1)

• Skin lipid profile of acne and healthy patients

  Compare the skin lipid profile of acne and healthy patients at baseline

  baseline visit

Secondary Outcomes (1)

• Skin lipid profile of acne patients after treatment

  at 1 month and 4-5 months of treatment

Study Arms (3)

Healthy Group

The subjects in this group do not have a history of acne.

Acne Group, Topical Retinoid

These subjects have been prescribed a topical retinoid for their acne. They will participate in the study for a period of 1 month.

Drug: Tretinoin or Adapalene

Acne Group, Isotretinoin

These subjects have been prescribed isotretinoin for their acne. They will participate in the study for a period of 5-6 months.

Drug: Isotretinoin

Interventions

Tretinoin or Adapalene DRUG

Subjects will apply a pea sized amount of topical retinoid cream once daily at night for 30 days. Subjects will return for a follow-up visit.

Also known as: Retin A

Acne Group, Topical Retinoid

Isotretinoin DRUG

Subjects will take one pill once daily for 5 months. Subjects will return after 1 month and after 4-5 months of treatment for skin lipid profiling.

Also known as: Accutane

Acne Group, Isotretinoin

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be from the UC Davis Dermatology Clinic, surrounding dermatology clinics, from the UC Davis undergraduate campus, and from the California State University Sacramento campus.

You may qualify if:

• age 12 to 30 years
• have been prescribed tretinoin OR isotretinoin

You may not qualify if:

• those who have taken isotretinoin (systemic)
• those who used tretinoin or other topical retinoid within two weeks of starting the study
• those with seborrheic dermatitis, rosacea, or polycystic ovary syndrome
• those who are pregnant, prisoners, or cognitively impaired

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (2)

Dermatology Research Area

Davis, California, 95616, United States

Location

UC Davis Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Publications (5)

• 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.

  PMID: 2648418 BACKGROUND

• 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.

  PMID: 8369207 BACKGROUND

• 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.

  PMID: 18474083 BACKGROUND

• 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.

  PMID: 9248884 BACKGROUND

• Morello AM, Downing DT, Strauss JS. Octadecadienoic acids in the skin surface lipids of acne patients and normal subjects. J Invest Dermatol. 1976 May;66(5):319-23. doi: 10.1111/1523-1747.ep12482300.

  PMID: 131844 BACKGROUND

Related Links

• University of California-Davis Department of Dermatology Clinical Research

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sebum collections from sebutapes

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Tretinoin; Adapalene; Isotretinoin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds

Study Officials

• Raja K Sivamani, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 2, 2014
• Study Start: November 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

US (2)