Skin Elasticity Measurements of the Face and Surgical Scars Stratified by Age and Skin Type

January 29, 2025 updated by: Murad Alam, Northwestern University

A Pilot Study of Skin Elasticity Measurements of the Face and Surgical Scars Stratified by Age and Skin Type

The primary objective of Part A is to compare the change in elasticity measurements at baseline and at 3 months between subjects who have had a resurfacing or tightening procedure and those who have not. The secondary objective for Part A is to develop baseline elasticity scores for ages 18-35, 36-50, and 51-65 and for Fitzpatrick skin types I-II, III-IV, and V-VI. The primary objective of Part B is to compare the age of the scar and surrounding tissue with the elasticity measurements.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine, Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Up to 350 subjects who meet the inclusion/exclusion criteria for either study Part A, Part B or both will be consented and enrolled with the goal of having 100 subjects complete Part A and 250 subjects complete Part B. Subjects will be recruited from the Dermatology Clinic at Northwestern University and other Northwestern University clinics.

Description

Inclusion Criteria:

Part A:

  • Subject is 18-65 years of age
  • Subject scheduled to have resurfacing or tightening procedure done as Standard of Care (Arm 1, 25 subjects).
  • The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator

Part B:

  • Subject is 18 and over
  • Subject has a linear surgical scar that is > 2cm.
  • The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator

Exclusion Criteria:

Part A, Group 1:

-Subject is planning on having a cosmetic procedure done to their face during the 3 months they are participating in the study (Arm 2, 25 subjects).

Parts A and B:

  • Under 18 years of age
  • Pregnancy or Lactation
  • Subjects who are unable to understand the protocol or to give informed consent
  • Subjects with mental illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Part A: 3 Arms
Subjects will be recruited and enrolled to fill one of three Arms. The first Arm will include 25 subjects who are scheduled to receive resurfacing or tightening procedures AS STANDARD OF CARE (CO2 resurfacing or tightening procedure (1 treatment), radiofrequency (2 tx), Fraxel ( 2 tx), or PDL. These subjects will have baseline elasticity measurements recorded on their face and right forearm before their procedures, and follow up measurements will be repeated 3 months following their last treatment. The second Arm will include 25 subjects who are not scheduled to receive any cosmetic procedures but who agree to return for repeated measurements 3 months following the first. Baseline elasticity measurements will be recorded from subjects' face and right forearm and subjects will return in 3 months for follow-up measurements. The third Arm will include the remaining 50 subjects; these subjects will have the elasticity measurements performed only once on their face and forearm.
Part B
The study population in the second cohort will consist of 250 subjects who have a surgical scar >2 cm in length. Subjects enrolled will have three elasticity measurements performed in one study visit. Elasticity will be measured directly in the center of the scar, 3cm perpendicular to the center of the scar, and 3cm in line from one end of the scar (Appendix 2).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Skin elasticity measurement of participant's scars
Time Frame: up to 3 months
Difference in skin elasticity measurements will be compared between subjects of varying ages at different anatomical sites: scarred sites, forehead, cheeks, mandible, and inner arm.
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Murad Alam, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU49554

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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