Microneedling vs Dermabrasion for Early Facial Scar Resurfacing

Scar Clinical Trial

Official title:

Microneedling vs Dermabrasion for Early Facial Scar Resurfacing

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06171386
• Other study ID #: IRB00102716
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cicatrix
• Scar

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