Nano Fat Injection With or Without Fractional Carbon Dioxide Laser in Acne Scars

Assessment of Nano Fat Grafting Combined With Fractional Carbon Dioxide Laser Resurfacing Versus Nano Fat Grafting Alone in Atrophic Facial Acne Scars

Assessment of nano fat grafting combined with carbon dioxide laser resurfacing versus nano fat grafting alone in treating facial atrophic acne scars

Study Overview

• Status: Not yet recruiting
• Conditions: Acne Scars - Atrophic
• Intervention / Treatment: Procedure: Fat grafting

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

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohammed H Abdelhafez, MBBS; Phone Number: +201099068855; Email: Dr.m.zayan@gmail.com
• Study Contact Backup: Name: sara M Awad, MD; Phone Number: +201023102094; Email: saramawad@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Faculty of Medicine, Assiut University
    • Contact: Mohammed H Abdelhafez, MBBS; Phone Number: 0882315377 +201099068855; Email: Dr.m.Zayan2@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nano fat grafting and fractional carbon dioxide laser resurfacing; treating of atrophic acne scars with nano fat and fractional carbon dioxide laser	Procedure: Fat grafting; Nano fat grafting followed by fractional carbon dioxide laser resurfacing; Other Names: fractional carbon dioxide laser resurfacing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 24 weeks
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	up to 24 weeks
Patient satisfaction	Patients will rate their overall satisfaction on a quartile grading system: 0, unsatisfied; 1, slightly satisfied; 2, satisfied; and 3, very satisfied	1 year
Adverse events	erythema, edema, crusting, pigmentary changes, ecchymosis, and scarring, will be recorded	1 year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: youssef S farrag, MD, Department of Plastic Surgery, professor; Principal Investigator: Wael S Ibraheem, MD, Department of Plastic Surgery , Assistant lecture

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): April 29, 2024
• Study Completion (Estimated): May 29, 2024

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: nano fat injection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No