Atopic DermatitisNCT00691366
Comprehensive Investigation of Heart Rate Variability as a Measure of the Autonomic Nervous System in Atopic Dermatitis
An observational study of Atopic Dermatitis, run by Wake Forest University at 1 site in United States.
Trial summary
The purpose of this research is to study heart rate patterns in people with moderate to severe atopic dermatitis and how itching affects those patterns. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Dec 2009
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Wake Forest University Health Sciences Dermatology Clinic population and from appropriate IRB-approved advertising in the community.
Who may be able to join
- Adult men and women who are between 18 and 50 years of age.
- Diagnosis of moderate to severe atopic dermatitis confirmed by published consensus diagnostic criteria26 (except for healthy control subjects). Severity will be based on an investigator's global assessment score and will have to be moderate or severe (IGA) (see Appendix 1).
- Subjects must be in general good health with no other skin disease, disease state or physical condition which would impair evaluation of their skin or which would increase their health risk by study participation as determined by the investigators.
- Women of child bearing potential will be required to have a negative pregnancy test in order to enroll in the study and will be required to maintain adequate birth control throughout the study. Reliable methods of birth control are: abstinence, oral contraceptives, intrauterine device (IUD), DepoProvera, Norplant, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship. An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or sponge.
- Subjects must cease using topical agents on the forearm where experimental data is going to be collected at least 1 week prior. Topical agents can be used on all other parts of the body.
- Subjects will be required to cease use of oral antihistamines for a period of one week prior to and during the study visit.
Who cannot join
- Adults over age 50.
- Children less than 18 years of age.
- Unable to complete the required measures.
- Diagnosis with other diseases that would affect the measurement of heart rate variability as determined by the investigators such as cardiovascular disease, hypertension, bradycardia (<60 beats per minute) and tachycardia (>100 beats per minute) amongst others.
- Diagnosis with other skin diseases that would affect the measurement of transepidermal water loss (TEWL) and skin hydration as determined by the investigators.
- Currently enrolled in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy and subjects undergoing treatment with another investigational drug or approved therapy for investigational use within 28 days prior to study participation.
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- Consistent consumption of more than 4 caffeinated beverages per day.
- Current treatment with oral lipophilic beta blockers, antihistamines, opioids, glucocorticoids, theophylline, anticholinergic medication or inhaled beta-agonists or anticholinergics or other medications known to interfere autonomic nervous system physiology.
- Asthma/Chronic Obstructive Airways Disease or other respiratory disease.
- Neuropathy causing diseases such as uremia.
- Uncontrolled thyroid disease.
- Diabetes mellitus.
- Use of illicit drugs.
- Current diagnosis of a psychiatric disorder27;28.
- History of chronic urticaria.
- History of anaphylactic shock.
- Allergy to histamine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Facility: Wake Forest University Health Sciences Dermatology
Winston-Salem, North Carolina, 27295
About this study
Official title: Autonomic Nervous System Physiology and Chronic Pruritus: A Comprehensive Investigation of Heart Rate Variability as a Measure of the Autonomic Nervous System in Atopic Dermatitis
The purpose of this research is to study heart rate patterns in people with moderate to severe atopic dermatitis and how itching affects those patterns.
Read the detailed description
To comprehensively evaluate the autonomic nervous system through heart rate variability (HRV) measurements in patients with moderate to severe atopic dermatitis suffering from pruritus.
- Conditions
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startMar 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gil Yosipovitch, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691366
- Sponsor's protocol ID
- 00002115
- Status last verified
- Jun 2008
- First submitted
- 2 Jun 2008
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Nervous System Physiology and Chronic Pruritus: A Comprehensive Investigation of Heart Rate Variability as a Measure of the Autonomic Nervous System in Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00691366
- Acronym / sponsor ID
- 00002115
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 5 Jun 2008 (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 research is to study heart rate patterns in people with moderate to severe atopic dermatitis and how itching affects those patterns.
Detailed description
To comprehensively evaluate the autonomic nervous system through heart rate variability (HRV) measurements in patients with moderate to severe atopic dermatitis suffering from pruritus.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Wake Forest University Health Sciences Dermatology Clinic population and from appropriate IRB-approved advertising in the community.
Key inclusion criteria (6 listed)
- Adult men and women who are between 18 and 50 years of age.
- Diagnosis of moderate to severe atopic dermatitis confirmed by published consensus diagnostic criteria26 (except for healthy control subjects). Severity will be based on an investigator's global assessment score and will have to be moderate or severe (IGA) (see Appendix 1).
- Subjects must be in general good health with no other skin disease, disease state or physical condition which would impair evaluation of their skin or which would increase their health risk by study participation as determined by the investigators.
- Women of child bearing potential will be required to have a negative pregnancy test in order to enroll in the study and will be required to maintain adequate birth control throughout the study. Reliable methods of birth control are: abstinence, oral contraceptives, intrauterine device (IUD), DepoProvera, Norplant, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship. An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or sponge.
- Subjects must cease using topical agents on the forearm where experimental data is going to be collected at least 1 week prior. Topical agents can be used on all other parts of the body.
Key exclusion criteria (17 listed)
- Adults over age 50.
- Children less than 18 years of age.
- Unable to complete the required measures.
- Diagnosis with other diseases that would affect the measurement of heart rate variability as determined by the investigators such as cardiovascular disease, hypertension, bradycardia (<60 beats per minute) and tachycardia (>100 beats per minute) amongst others.
- Diagnosis with other skin diseases that would affect the measurement of transepidermal water loss (TEWL) and skin hydration as determined by the investigators.
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
Not reported in the source record.
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 16 Mar 2017.
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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.
Gil Yosipovitch, MD principal investigator
Wake Forest University Health Sciences
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 Atopic Dermatitis, run by Wake Forest University 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 17 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 16 Mar 2017. 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.
Where can I read the original study information?
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 16 Mar 2017.