NCT01545973

Brief Summary

The purpose of this study is to evaluate the effects of skin thickness, skin moisture, and sweat gland density on Scanning Kelvin Probe measurements.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

March 2, 2012

Last Update Submit

March 2, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Surface Electrical Potential

    The electrical potential of skin obtained from the Scanning Kelvin Probe

    1 day

Secondary Outcomes (1)

  • Electrical Impedance

    One day

Study Arms (1)

Healthy Volunteers

Human subjects without chronic medical conditions, defined as conditions requiring chronic medication use.

Other: Skin Moistening, Skin Denuding

Interventions

Application of normal saline to skin and Tape stripping of the superficial skin

Healthy Volunteers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy Volunteers

You may qualify if:

  • "Healthy" is defined as not having a chronic medical condition requiring daily medications (hypertension, diabetes, hypothyroidism, etc)

You may not qualify if:

  • autonomic disorders (sweating irregularities), skin disorders, extensive burns/scars on the hand, tremors, neuromuscular conditions, restless leg syndrome, movement disorders, and implanted cardiac defibrillator/pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital - Martinos Center for Biomedical Imaging

Charlestown, Massachusetts, 02129, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

Study Officials

  • Andrew C. Ahn, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 2, 2012

First Posted

March 7, 2012

Study Start

August 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

March 7, 2012

Record last verified: 2012-03

Locations