HealthyNCT02457000
Sleep, Circadian Rhythm & Skin Health
An observational study of Healthy and Psoriasis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults from Northeast Ohio who are either healthy, normal volunteers or have skin pathology including but not limited to eczema, psoriasis, acne, and other inflammatory dermatoses
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44118
About this study
The purpose of this study is to explore the mechanisms behind how sleep quality may affect skin aging, skin integrity and skin disease.
- Keywords
- Sleep, Skin, Circadian Rhythm
- Medical subject headings
- Psoriasis, Eczema, Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7-14 days
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.
Measured: Only once during the study or at specific time points depending on what other procedures are being performed
Secondary outcomes (3)
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.
Measured: Only once during the study or at specific time points depending on what other procedures are being performed
Skin Barrier Recovery (via TEWL measurement)
Skin barrier recovery via Transepidermal Water Loss (TEWL) measurement may be assessed in some volunteers.
Measured: Only once during the study or at specific time points depending on what other procedures are being performed
MED Testing & Recovery from UV-induced erythema
MED Testing \& Recovery from UV-induced erythema may be assessed in some volunteers.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kevin Cooper, University Hospitals Cleveland Medical Center
- Investigators
- Kevin Cooper, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457000
- Sponsor's protocol ID
- 12-14-23
- Status last verified
- Nov 2021
- First submitted
- 18 Mar 2015
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25266053Rogiers 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. doi: 10.1159/000056341.
PubMed 11316970Vierkotter A, Ranft U, Kramer 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.
PubMed 19059763
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Circadian Rhythm & Skin Health
- ClinicalTrials.gov ID
- NCT02457000
- Acronym / sponsor ID
- 12-14-23
- Keywords
- Sleep, Skin, Circadian Rhythm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the mechanisms behind how sleep quality may affect skin aging, skin integrity and skin disease.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults from Northeast Ohio who are either healthy, normal volunteers or have skin pathology including but not limited to eczema, psoriasis, acne, and other inflammatory dermatoses
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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 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
MED Testing & Recovery from UV-induced erythema
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Background: PubMed 25266053Oyetakin-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.
- Background: PubMed 11316970Rogiers 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. doi: 10.1159/000056341.
- Background: PubMed 19059763Vierkotter A, Ranft U, Kramer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Cooper, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Psoriasis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of Sleep Pattern via Actigraphy, Polysomnography & Questionnaires (time frame: 7-14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02457000, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.