Sleep, Circadian Rhythm & Skin Health

Healthy Clinical Trial

Official title:

Sleep, Circadian Rhythm & Skin Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02457000
• Other study ID #: 12-14-23
• Status: Completed
• Start date: March 2015
• Est. completion date: August 2020

Study information

• Verified date: November 2021
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to explore the mechanisms behind how sleep quality may affect skin aging, skin integrity and skin disease.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acne
• Eczema
• Healthy
• Psoriasis

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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