Back to resultsNano Fat Injection With or Without Fractional Carbon Dioxide Laser in Acne Scars
Primary Purpose
Acne Scars - Atrophic
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fat grafting
Sponsored by
About this trial
This is an interventional treatment trial for Acne Scars - Atrophic
Eligibility Criteria
Inclusion Criteria: patients older than 18 years who attend the Outpatient Clinics of Dermatology and Plastic Surgery Departments, Assiut University Hospital, with moderate to severe atrophic facial acne scars on both cheeks, as assessed using the Goodman and Baron Qualitative scar grading system (12), will be enrolled in the study. Exclusion Criteria: include: pregnancy or lactation; active acne, history of deep chemical peeling or filler injection in the previous 6 months, history of keloid or hypertrophic scar formation; use of isotretinoin in the previous 6 months; active infection in the treatment area; bleeding tendencies; history of herpes simplex or herpes zoster infection on the face; and patients with unrealistic expectations.
Sites / Locations
- Faculty of Medicine, Assiut University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nano fat grafting and fractional carbon dioxide laser resurfacing
Arm Description
treating of atrophic acne scars with nano fat and fractional carbon dioxide laser
Outcomes
Primary Outcome Measures
Clinical assessment of acne scar severity
as assessed using the Goodman and Baron Qualitative scar grading system before and after treatment on both sides of face, to determine the number of patients achieving two grades improvement vs one grade or no improvement
Secondary Outcome Measures
Physician global assessment
two blinded observers will compare the before and after photographs separately on each facial side and will evaluate the improvement on a quartile grading scale as: poor,<25% improvement; fair, 25%-50% improvement; good, 51%-75% improvement; and excellent, >75% improvement.
percent of reduction in scar count
count of the total and different types of acne scars was performed, before and after treatment on both sides of the face, and the percent of reduction was calculated
Patient satisfaction
Patients will rate their overall satisfaction on a quartile grading system: 0, unsatisfied; 1, slightly satisfied; 2, satisfied; and 3, very satisfied
Adverse events
erythema, edema, crusting, pigmentary changes, ecchymosis, and scarring, will be recorded
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05985265
Brief Title
Nano Fat Injection With or Without Fractional Carbon Dioxide Laser in Acne Scars
Official Title
Assessment of Nano Fat Grafting Combined With Fractional Carbon Dioxide Laser Resurfacing Versus Nano Fat Grafting Alone in Atrophic Facial Acne Scars
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
April 29, 2024 (Anticipated)
Study Completion Date
May 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Assessment of nano fat grafting combined with carbon dioxide laser resurfacing versus nano fat grafting alone in treating facial atrophic acne scars
Detailed Description
Acne scars is a world wide problem .though lots of treatment exists still mo gold standard for treatment of acne scars in this study.
Assessment of nano fat grafting combined with carbon dioxide laser resurfacing versus nano fat grafting alone in treating facial atrophic acne scars
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars - Atrophic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nano fat grafting and fractional carbon dioxide laser resurfacing
Arm Type
Experimental
Arm Description
treating of atrophic acne scars with nano fat and fractional carbon dioxide laser
Intervention Type
Procedure
Intervention Name(s)
Fat grafting
Other Intervention Name(s)
fractional carbon dioxide laser resurfacing
Intervention Description
Nano fat grafting followed by fractional carbon dioxide laser resurfacing
Primary Outcome Measure Information:
Title
Clinical assessment of acne scar severity
Description
as assessed using the Goodman and Baron Qualitative scar grading system before and after treatment on both sides of face, to determine the number of patients achieving two grades improvement vs one grade or no improvement
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Physician global assessment
Description
two blinded observers will compare the before and after photographs separately on each facial side and will evaluate the improvement on a quartile grading scale as: poor,<25% improvement; fair, 25%-50% improvement; good, 51%-75% improvement; and excellent, >75% improvement.
Time Frame
up to 24 weeks
Title
percent of reduction in scar count
Description
count of the total and different types of acne scars was performed, before and after treatment on both sides of the face, and the percent of reduction was calculated
Time Frame
up to 24 weeks
Title
Patient satisfaction
Description
Patients will rate their overall satisfaction on a quartile grading system: 0, unsatisfied; 1, slightly satisfied; 2, satisfied; and 3, very satisfied
Time Frame
1 year
Title
Adverse events
Description
erythema, edema, crusting, pigmentary changes, ecchymosis, and scarring, will be recorded
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients older than 18 years who attend the Outpatient Clinics of Dermatology and Plastic Surgery Departments, Assiut University Hospital, with moderate to severe atrophic facial acne scars on both cheeks, as assessed using the Goodman and Baron Qualitative scar grading system (12), will be enrolled in the study.
Exclusion Criteria:
include: pregnancy or lactation; active acne, history of deep chemical peeling or filler injection in the previous 6 months, history of keloid or hypertrophic scar formation; use of isotretinoin in the previous 6 months; active infection in the treatment area; bleeding tendencies; history of herpes simplex or herpes zoster infection on the face; and patients with unrealistic expectations.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohammed H Abdelhafez, MBBS
Phone
+201099068855
Email
Dr.m.zayan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
sara M Awad, MD
Phone
+201023102094
Email
saramawad@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
youssef S farrag, MD
Organizational Affiliation
Department of Plastic Surgery, professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wael S Ibraheem, MD
Organizational Affiliation
Department of Plastic Surgery , Assistant lecture
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Assiut University
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed H Abdelhafez, MBBS
Phone
+201099068855
Ext
0882315377
Email
Dr.m.Zayan2@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17199653
Citation
Goodman GJ, Baron JA. Postacne scarring: a qualitative global scarring grading system. Dermatol Surg. 2006 Dec;32(12):1458-66. doi: 10.1111/j.1524-4725.2006.32354.x.
Results Reference
background
PubMed Identifier
11423843
Citation
Jacob CI, Dover JS, Kaminer MS. Acne scarring: a classification system and review of treatment options. J Am Acad Dermatol. 2001 Jul;45(1):109-17. doi: 10.1067/mjd.2001.113451.
Results Reference
result
PubMed Identifier
20976801
Citation
Chan NP, Ho SG, Yeung CK, Shek SY, Chan HH. Fractional ablative carbon dioxide laser resurfacing for skin rejuvenation and acne scars in Asians. Lasers Surg Med. 2010 Nov;42(9):615-23. doi: 10.1002/lsm.20974.
Results Reference
result
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Nano Fat Injection With or Without Fractional Carbon Dioxide Laser in Acne Scars
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