- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06171386
Microneedling vs Dermabrasion for Early Facial Scar Resurfacing
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Candace M Waters, MD
- Phone Number: 336-716-4000
- Email: cmwaters@wakehealth.edu
Study Contact Backup
- Name: Alexa l Lacy
- Phone Number: 336-716-3850
- Email: Alexa.Lacy@advocatehealth.org
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest University Health Sciences
-
Contact:
- Candace M Waters, MD
- Phone Number: 336-716-4000
- Email: cmwaters@wakehealth.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: microneedling
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
|
a form of collagen induction therapy
|
|
Active Comparator: dermabrasion
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
|
a technique that improves the skin structure, quality, and appearance of scars through collagen remodeling and reepithelization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Vancouver Scar Scale Scores
Time Frame: Month 7
|
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
Time Frame: Month 7
|
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
Time Frame: Month 7
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient perceived benefit
Time Frame: At time of procedure (pain scale); at 6 months (yes/no)
|
At the time of intervention, patients will be asked to rank pain of procedure on a scale of 1-10 (1: minimal discomfort, 10: severe pain).
At 6 months, they will also give a yes/no response as to whether they would undergo the study protocol (procedure) again.
|
At time of procedure (pain scale); at 6 months (yes/no)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Candace M Water, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Fibrosis
- Pathological Conditions, Signs and Symptoms
- Cicatrix
- Therapeutics
- Punctures
- Surgical Procedures, Operative
- Complementary Therapies
- Physical Therapy Modalities
- Rehabilitation
- Plastic Surgery Procedures
- Cosmetic Techniques
- Dermatologic Surgical Procedures
- Percutaneous Collagen Induction
- Dermabrasion
Other Study ID Numbers
- IRB00102716
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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