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

Skin Elasticity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01688063
• Other study ID #: STU49554
• Status: Active, not recruiting
• Start date: July 2011
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix
• Skin Elasticity
• Skin Scarring

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin elasticity measurement of participant's scars	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