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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06171386
Other study ID # IRB00102716
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date April 2026

Study information

Verified date December 2023
Source Wake Forest University Health Sciences
Contact Candace M Waters, MD
Phone 336-716-4000
Email cmwaters@wakehealth.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to determine whether microneedling or dermabrasion in the early post-operative period is superior in improving the appearance of surgical scars on the face.


Description:

Microneedling and dermabrasion are two common modalities that may be performed in-office to treat surgical scars. Microneedling is a form of collagen induction therapy, often used in conjunction with platelet-rich plasma or hyaluronic acid. Dermabrasion is a technique that improves the skin structure, quality, and appearance of scars through collagen remodeling and reepithelization. To determine which modality is most effective, a prospective study; randomizing a volunteer sample of adult patients with new surgical vertical forehead scars will receive either dermabrasion or microneedling in the early postoperative period.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date April 2026
Est. primary completion date April 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Volunteer adult patients will be identified by visiting the Facial Plastics and Reconstructive Surgery Clinic at Atrium Health Wake Forest Baptist. - Patients will be 18 years old+ and have a vertical surgical scar in the superior 1/3 of the face (trichion to glabella). - Patients will enroll in the clinic research registry and indicate an interest in being involved in the study. Exclusion Criteria: - Patients who rate Types 4-6 on the Fitzpatrick scale will be excluded due to risk of poor outcome from dermabrasion. - There are no other planned exclusion criteria. Patients will not be excluded on the basis of gender, race/ethnicity, or age, provided that they meet the described inclusion criteria.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Microneedling
a form of collagen induction therapy
Dermabrasion
a technique that improves the skin structure, quality, and appearance of scars through collagen remodeling and reepithelization

Locations

Country Name City State
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Vancouver Scar Scale Scores Four characteristics of the scar are assessed. These are: vascularity, height, pliability, and pigmentation. Each characteristic is given a score, which are added together to give an overall score between 0 and 13 - lower scores denoting normal skin Month 7
Primary Change in Patient and Observer Scar Assessment Scale Scores Items and total scale scores for the patient and observer: Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60 - lower scores denoting normal skin Month 7
Primary Change in Global Aesthetic Improvement Scale Scores 5-point scale wherein 2 = much improved (marked improvement in appearance), 1 = improved (improvement in appearance but a touch-up or re-treatment is indicated - lower scores denoting normal skin Month 7
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