Healthy Clinical Trial
Official title:
Sleep, Circadian Rhythm & Skin Health
NCT number | NCT02457000 |
Other study ID # | 12-14-23 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | August 2020 |
Verified date | November 2021 |
Source | University Hospitals Cleveland Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to explore the mechanisms behind how sleep quality may affect skin aging, skin integrity and skin disease.
Status | Completed |
Enrollment | 59 |
Est. completion date | August 2020 |
Est. primary completion date | August 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Males or females ages 18 years and above - Capable of giving informed consent - Adults who are either healthy, normal volunteers or those with a skin disease including but not limited to eczema, psoriasis, acne or other inflammatory dermatoses - Fitzpatrick Skin Type I-VI - In good general health - Willing to cooperate with study instructions Exclusion Criteria: - Volunteers 18 years or younger - Any serious medical or physical condition that would cause the subject significant discomfort with study procedures - Women who are pregnant, nursing, or who may become pregnant in the next 3 months |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Cleveland Medical Center |
United States,
Oyetakin-White P, Suggs A, Koo B, Matsui MS, Yarosh D, Cooper KD, Baron ED. Does poor sleep quality affect skin ageing? Clin Exp Dermatol. 2015 Jan;40(1):17-22. doi: 10.1111/ced.12455. Epub 2014 Sep 30. — View Citation
Rogiers V; EEMCO Group. EEMCO guidance for the assessment of transepidermal water loss in cosmetic sciences. Skin Pharmacol Appl Skin Physiol. 2001 Mar-Apr;14(2):117-28. — View Citation
Vierkötter A, Ranft U, Krämer U, Sugiri D, Reimann V, Krutmann J. The SCINEXA: a novel, validated score to simultaneously assess and differentiate between intrinsic and extrinsic skin ageing. J Dermatol Sci. 2009 Mar;53(3):207-11. doi: 10.1016/j.jdermsci.2008.10.001. Epub 2008 Dec 6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Analysis of Sleep Pattern via Actigraphy, Polysomnography & Questionnaires | 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. | 7-14 days | |
Primary | Evaluation of skin (both in terms of skin aging and skin disease) | 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. | Only once during the study or at specific time points depending on what other procedures are being performed | |
Secondary | Sample Analysis (from skin, blood, urine, saliva and hair follicle samples) | 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. | Only once during the study or at specific time points depending on what other procedures are being performed | |
Secondary | Skin Barrier Recovery (via TEWL measurement) | Skin barrier recovery via Transepidermal Water Loss (TEWL) measurement may be assessed in some volunteers. | Only once during the study or at specific time points depending on what other procedures are being performed | |
Secondary | MED Testing & Recovery from UV-induced erythema | MED Testing & Recovery from UV-induced erythema may be assessed in some volunteers. | 24 hours |
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