- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07599709
LONG PULSED ND:YAG LASER (1064 NM) VERSUS INTENSE PULSED LIGHT IN TREATMENT OF TRAUMATIC AND POST-SURGICAL ERYTHEMATOUS SCARS
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alexandria Governorate
-
Alexandria, Alexandria Governorate, Egypt, 55555
- Alexandria main university hospital, Department of dermatology and venerology.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients of either gender, aged more than 12 years, presenting with an erythematous scar on the head and neck area, traumatic or post-surgical, and of a duration equal to or less than six months.
Exclusion Criteria:
1. Patients with post burn scars, scars of more than six months duration, keloids, post acne atrophic erythematous scars or scars that are not located on the head and neck area.
2. Patients with active bacterial, viral, or fungal cutaneous infection within the scar tissue.
3. Patients who are pregnant or lactating. 4. Known contraindication to laser therapy. 5. Use of Isotretinoin within the previous 6 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group B
|
Intense Pulsed Light (light based modality)
|
|
Active Comparator: Group A
|
Long Pulsed ND:YAG laser (1064 nm)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compare the efficacy and safety of long-pulsed Nd-YAG laser and intense pulsed light in the treatment of traumatic and post-surgical erythematous scars.
Time Frame: From enrollment to 3 months after last treatment sessions, where four sessions were given at four-week intervals.
|
The efficacy were assessed using the Patient and Observer scar assessment scale as well as subjective and objective assessment of scar erythema
|
From enrollment to 3 months after last treatment sessions, where four sessions were given at four-week intervals.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 0107942
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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