Cutis LaxaNCT01293864
Structural Analysis of Human Tissue
An observational study of Cutis Laxa, run by Wake Forest University at 1 site in United States.
Trial summary
The object of this study is to analyze fresh human skin samples using several up-to-date technologies to get parameters on the mechanical, biochemical and structural distribution of the main components of the capillary-tissue unit. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cutis Laxa
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Apr 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population consists of patients who are being seen in the Plastic \& Reconstructive Surgery Clinic for surgical removal of excess abdominal skin (abdominoplasty).
Who may be able to join
- Subjects, male or female , between the ages of 18 to 65 years of age, who will be having surgery to remove excess skin from the abdominal area by surgeons in the Department of Plastic \& Reconstructive Surgery
Who cannot join
- Subjects younger then 18 years of age or older than 65 years of age, and are not having excxess skin surgically removed
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University School of Medicine, Department of Plastic & Reconstructive Surgery
Winston-Salem, North Carolina, 27157-1075
About this study
The object of this study is to analyze fresh human skin samples using several up-to-date technologies to get parameters on the mechanical, biochemical and structural distribution of the main components of the capillary-tissue unit.
Our working hypothesis is that both structural components of the dermis are not evenly distributed along parallel planes. The investigators further hypothesize the the distribution patterns determine functional and mechanical differences along dermal layers.
Read the detailed description
Background The skin is a large organ that participates in many protective and homeostatic processes. The functions of the skin can be roughly divided into systemic and local ; both are interrelated but relationships are poorly understood and studying them requires a multiscale approach. Particularly, for the local responses that are mediated by activation of proteolytic and signaling pathways such as coagulation and inflammation, the relevant scale corresponds to the micrometer and nanometer dimensions of cells and macromolecules, respectively. There is very little information on the physicochemical characteristics of the skin at these scales.
Objective The investigators propose to analyze fresh human skin samples using several up-to-date technologies to obtain parameters on the mechanical, biochemical and structural distribution of the main components of the capillary-tissue unit.
Hypothesis/Rationale Our working hypothesis is that both structural components of the dermis, such as glycosaminoglycans, and key mediators of homeostatic pathways, such as the procoagulant tissue factor are not evenly distributed along parallel planes. The investigators further hypothesize that the distribution patterns determine functional and mechanical differences along dermal layers.
Methods Using a dermatome, human skin will be dissected along planes parallel to the epidermis into several layers each approximately .0012mm thick. The layers will be analyzed with respect to composition of diffusible proteins and glycosaminoglycans; subjected to high resolution MRI and AFM scanning; and evaluated for swelling rate and equilibrium swelling pressure.
Significance This study will provide new information on material characteristics and functional structure of the human skin at resolutions relevant to the macromolecular and cellular processes that mediate local responses to injury and maintain local homeostatic mechanisms. The data will be further processed to obtain realistic parameters that are needed to develop predictive models of the skin capillary tissue unit. These models will bring new and deeper understanding on skin physiology and pathology and will aid in the discovery and testing of new preventive and therapeutic approaches targeting dysfunctions of the local homeostatic balance in the skin. Potentially, by exploiting the versatility of mathematical simulations in the skin model, the findings will also be applicable to other tissue organs.
- Conditions
- Cutis Laxa
- Keywords
- structural analysis, diffusible proteins, glycosaminoglycans
- Medical subject headings
- Cutis Laxa
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startApr 2007
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: This is not a clinical trials study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutis LaxaStudies 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
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J Morykwas, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293864
- Sponsor's protocol ID
- IRB00002154
- Status last verified
- Dec 2015
- First submitted
- 10 Feb 2011
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural Analysis of Human Tissue
- ClinicalTrials.gov ID
- NCT01293864
- Acronym / sponsor ID
- IRB00002154
- Conditions
- Cutis Laxa
- Keywords
- structural analysis, diffusible proteins, glycosaminoglycans
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This is not a clinical trials study
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 11 Feb 2011 (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 object of this study is to analyze fresh human skin samples using several up-to-date technologies to get parameters on the mechanical, biochemical and structural distribution of the main components of the capillary-tissue unit.
Our working hypothesis is that both structural components of the dermis are not evenly distributed along parallel planes. The investigators further hypothesize the the distribution patterns determine functional and mechanical differences along dermal layers.
Detailed description
Background The skin is a large organ that participates in many protective and homeostatic processes. The functions of the skin can be roughly divided into systemic and local ; both are interrelated but relationships are poorly understood and studying them requires a multiscale approach. Particularly, for the local responses that are mediated by activation of proteolytic and signaling pathways such as coagulation and inflammation, the relevant scale corresponds to the micrometer and nanometer dimensions of cells and macromolecules, respectively. There is very little information on the physicochemical characteristics of the skin at these scales.
Objective The investigators propose to analyze fresh human skin samples using several up-to-date technologies to obtain parameters on the mechanical, biochemical and structural distribution of the main components of the capillary-tissue unit.
Hypothesis/Rationale Our working hypothesis is that both structural components of the dermis, such as glycosaminoglycans, and key mediators of homeostatic pathways, such as the procoagulant tissue factor are not evenly distributed along parallel planes. The investigators further hypothesize that the distribution patterns determine functional and mechanical differences along dermal layers.
Methods Using a dermatome, human skin will be dissected along planes parallel to the epidermis into several layers each approximately .0012mm thick. The layers will be analyzed with respect to composition of diffusible proteins and glycosaminoglycans; subjected to high resolution MRI and AFM scanning; and evaluated for swelling rate and equilibrium swelling pressure.
Significance This study will provide new information on material characteristics and functional structure of the human skin at resolutions relevant to the macromolecular and cellular processes that mediate local responses to injury and maintain local homeostatic mechanisms. The data will be further processed to obtain realistic parameters that are needed to develop predictive models of the skin capillary tissue unit. These models will bring new and deeper understanding on skin physiology and pathology and will aid in the discovery and testing of new preventive and therapeutic approaches targeting dysfunctions of the local homeostatic balance in the skin. Potentially, by exploiting the versatility of mathematical simulations in the skin model, the findings will also be applicable to other tissue organs.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population consists of patients who are being seen in the Plastic \& Reconstructive Surgery Clinic for surgical removal of excess abdominal skin (abdominoplasty).
Key inclusion criteria (1 listed)
- Subjects, male or female , between the ages of 18 to 65 years of age, who will be having surgery to remove excess skin from the abdominal area by surgeons in the Department of Plastic \& Reconstructive Surgery
Key exclusion criteria (1 listed)
- Subjects younger then 18 years of age or older than 65 years of age, and are not having excxess skin surgically removed
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 was stopped early (reason given: This is not a clinical trials study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 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.
Michael J Morykwas, PhD 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 Cutis Laxa, 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 6 Nov 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 was stopped early (reason given: This is not a clinical trials study). Results are not available in the source record.
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 6 Nov 2017; AzTrials last refreshed its copy on 31 Oct 2026.