Sleep, Circadian Rhythm & Skin Health
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02457000|
Recruitment Status : Recruiting
First Posted : May 29, 2015
Last Update Posted : December 4, 2015
|Condition or disease|
|Healthy Psoriasis Eczema Acne|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Sleep, Circadian Rhythm & Skin Health|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Normal, healthy volunteers
Normal, healthy volunteers without any skin pathology will be asked to undergo various procedures to evaluate their sleep and skin health.
Volunteers with skin pathology
Volunteers with skin pathology including but not limited to eczema, psoriasis, acne, and other inflammatory dermatoses will be asked to undergo various procedures to evaluate their sleep and skin health.
- Analysis of Sleep Pattern via Actigraphy, Polysomnography & Questionnaires [ Time Frame: 7-14 days ]The volunteers may be asked to wear a wrist actigraph to measure movement. This watch would be worn for 24 hours per day for 7-14 days. The volunteer may also be asked to fill out questionnaires regarding their sleep patterns. Note: Other methods of assessing sleep patterns may also be used including a portable polysomnogram or a standard, overnight sleep study.
- Evaluation of skin (both in terms of skin aging and skin disease) [ Time Frame: Only once during the study or at specific time points depending on what other procedures are being performed ]The volunteers may have their skin evaluated for skin aging using the SCINEXA tool. Volunteers with psoriasis may have their skin evaluated via PASI and/or PGA assessments. Volunteers may have photographs taken to compare clinical appearance with laboratory and research findings.
- Sample Analysis (from skin, blood, urine, saliva and hair follicle samples) [ Time Frame: Only once during the study or at specific time points depending on what other procedures are being performed ]Skin, blood, urine, saliva and hair follicle samples may be collected from some volunteers to look at various markers related to sleep, the circadian rhythm and skin disease.
- Skin Barrier Recovery (via TEWL measurement) [ Time Frame: Only once during the study or at specific time points depending on what other procedures are being performed ]Skin barrier recovery via Transepidermal Water Loss (TEWL) measurement may be assessed in some volunteers.
- MED Testing & Recovery from UV-induced erythema [ Time Frame: 24 hours ]MED Testing & Recovery from UV-induced erythema may be assessed in some volunteers.
Biospecimen Retention: Samples Without DNA
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): NCT02457000
|Contact: A'ja Pattersonfirstname.lastname@example.org|
|Contact: Mary Consolo, BSemail@example.com|
|United States, Ohio|
|University Hospitals Case Medical Center||Recruiting|
|Cleveland, Ohio, United States, 44118|
|Contact: Mary Consolo, BS 216-844-7546 firstname.lastname@example.org|
|Principal Investigator:||Elma Baron, MD||University Hospitals Cleveland Medical Center|