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

NCT ID: NCT01688063

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Skin Scarring; Skin Elasticity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Murad Alam

Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU49554

Identifier Type: -

Identifier Source: org_study_id