NCT06298591

Brief Summary

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)

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Mar 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Mar 2024Mar 2027

First Submitted

Initial submission to the registry

March 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2027

Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

3 years

First QC Date

March 1, 2024

Last Update Submit

March 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • change of dermal thickness in sonar and Vancouver scale

    objective

    3 years

Study Arms (1)

subcision

OTHER
Procedure: co2 laser

Interventions

co2 laserPROCEDURE

laser

Also known as: fractional co2 laser
subcision

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients aged from 12 to 60 years with
  • post inflammatory atrophic scar.
  • post traumatic atrophic scar.
  • post operative atrophic scar

You may not qualify if:

  • post acne scar.
  • active skin infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Lasers, Gas

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

March 1, 2024

First Posted

March 7, 2024

Study Start

March 15, 2024

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

March 15, 2027

Last Updated

March 7, 2024

Record last verified: 2024-03