De Novo Lipogenesis of Sebaceous Glands in Acne
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|ClinicalTrials.gov Identifier: NCT02620813|
Recruitment Status : Recruiting
First Posted : December 3, 2015
Last Update Posted : June 29, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: Tretinoin Drug: Isotretinoin||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
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 Name: Retin-A
Experimental: Acne Subjects on Systemic Isotretinoin Treatment
Subjects with acne before and after isotretinoin therapy
Subjects will take isotretinoin as prescribed by their dermatologist.
- Sebumeter measurement differences before and after treatment with isotretinoin [ Time Frame: 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 ]
- Change in the global acne grade score [ Time Frame: 3 months ]
- Change in the investigator global assessment of acne [ Time Frame: 3 months ]
- Change in the lesion counts of inflammatory and non-inflammatory lesions. [ Time Frame: 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620813
|Contact: Raja K Sivamani, MDemail@example.com|
|Contact: Negar Foolad, MASfirstname.lastname@example.org|
|United States, California|
|Dermatology Research Area||Recruiting|
|Davis, California, United States, 95616|
|Contact: Negar Foolad, MAS 916-734-1509 email@example.com|
|Contact: Lauren A Hassoun, BS 916-734-6550 firstname.lastname@example.org|
|Principal Investigator: Raja K Sivamani, MD|
|UC Davis Department of Dermatology||Recruiting|
|Sacramento, California, United States, 95816|
|Contact: Raja Sivamani, MD email@example.com|