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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02180425
Other study ID # 531506
Secondary ID
Status Completed
Phase N/A
First received June 30, 2014
Last updated May 25, 2017
Start date November 2013
Est. completion date July 2015

Study information

Verified date May 2017
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Skin lipid profile will be conducted via sebutapes- adhesive tapes that painlessly absorbs sebum from the face. These tapes will be placed on the face for 1 hour. A photograph of the face will be taken during each study visit. A sebumeter will also be used to measure skin sebum secretion rate.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 30 Years
Eligibility Inclusion Criteria:

- age 12 to 30 years

- have been prescribed tretinoin OR isotretinoin

Exclusion Criteria:

- 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

- those who do not fit the inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tretinoin or Adapalene
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.
Isotretinoin
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.

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 (5)

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

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

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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary Skin lipid profile of acne and healthy patients Compare the skin lipid profile of acne and healthy patients at baseline baseline visit
Secondary Skin lipid profile of acne patients after treatment Patients in the topical retinoid group will have their lipids evaluated after 1 month of treatment. Patients in the systemic retinoid (isotretinoin) group will have their lipids evaluated after 1 and 4-5 months of treatment. at 1 month and 4-5 months of treatment
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