Microneedling vs Dermabrasion for Early Facial Scar Resurfacing

NCT06171386 | Recruiting

• 1 other identifier: IRB00102716
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Scar

Keywords

Dermabrasion; Microneedling; Surgical scars

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (1)

• Patient perceived benefit

  At time of procedure (pain scale); at 6 months (yes/no)

Study Arms (2)

microneedling

ACTIVE COMPARATOR

microneedling is a form of collagen induction therapy, often used in conjunction with platelet-rich plasma or hyaluronic acid - Patients will receive two treatments, once at 6-8 weeks following facial surgery, and the second at 12-16 weeks following facial surgery

Procedure: Microneedling

dermabrasion

ACTIVE COMPARATOR

dermabrasion is a technique that improves the skin structure, quality, and appearance of scars through collagen remodeling and reepithelization - Patients will receive the standard of care treatment 6-10 weeks following facial surgery

Procedure: Dermabrasion

Interventions

Microneedling PROCEDURE

a form of collagen induction therapy

microneedling

Dermabrasion PROCEDURE

a technique that improves the skin structure, quality, and appearance of scars through collagen remodeling and reepithelization

dermabrasion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who rate Types 4-6 on the Fitzpatrick scale will be excluded due to risk of poor outcome from dermabrasion.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Cicatrix

Interventions

Percutaneous Collagen Induction; Dermabrasion

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation; Cosmetic Techniques; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Candace M Water, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candace M Waters, MD

CONTACT

336-716-4000; cmwaters@wakehealth.edu

Lauren G Himes, MD

CONTACT

336-716-3850; lhimes@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be invited to participate in the study through the clinic setting - aim to have around 30 patient volunteers. Of the 30 patients, 15 will be randomized to receive microneedling, and 15 will receive dermabrasion.

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 14, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available after all data collection is complete in order to perform independent blinded analysis of scars at all time points.
• Access Criteria: Researchers on the study protocol involved in scar assessment

Locations

US (1)