- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06298591
The Efficacy of Combination Therapy in Atrophic Scars
The Efficacy of Subcision in Combination With PRP Injection and Fractional Co2 Laser in Treatment of Atrophic Scar: Clinical and Ultrasonic Study
There are more than 100 million patients who develop scar formation caused by various factors, such as post-inflammatory acne and trauma (1). They often have physical, aesthetic, psychological, and social barriers. Scar tissue is naturally a stage of wound healing. Abnormal wound healing produces a spectrum of scar tissue types such as atrophic, hypertrophic, and keloid scars (2).
Atrophic scars are dermal depressions, which are commonly caused by the destruction of collagen following inflammatory process. This permanent disfiguring sequelae correlates with the duration of pathology, severity of lesion, and delay in therapy (3).
Treatment of atrophic acne scars remains a therapeutic challenge, yet there is no standard option as the most effective treatment (4). A range of possible options has been investigated including surgical techniques (subcision, non-ablative laser treatment, resurfacing techniques (ablative laser treatment, dermabrasion), and injection or dermal fillers or fat, and a combination of two or more modalities (5).
Ultrasound is a unique non-invasive and non-radiating medical imaging tool in the investigation of dermatological diseases by providing detailed anatomic and physiologic data of skin lesions and deeper soft tissue changes. Lesion size in three dimensions-lengths, width, and depth, morphology, the detailed anatomic information provided by sonography is useful to assessment of effect of different types of treatment modality to improve atrophic scar and avoid invasive assessment tools as punch biopsy for histopathological examination (6)
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged from 12 to 60 years with
- post inflammatory atrophic scar.
- post traumatic atrophic scar.
- post operative atrophic scar
Exclusion Criteria:
- post acne scar.
- active skin infection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: subcision
|
laser
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change of dermal thickness in sonar and Vancouver scale
Time Frame: 3 years
|
objective
|
3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- atrophic scar treatment
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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