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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05985265
Collaborator
(none)
50
1
1
8.9
5.6

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Fat grafting
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Assessment of Nano Fat Grafting Combined With Fractional Carbon Dioxide Laser Resurfacing Versus Nano Fat Grafting Alone in Atrophic Facial Acne Scars
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Apr 29, 2024
Anticipated Study Completion Date :
May 29, 2024

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Clinical assessment of acne scar severity [up to 24 weeks]

      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

    1. Physician global assessment [up to 24 weeks]

      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.

    2. percent of reduction in scar count [up to 24 weeks]

      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

    3. Patient satisfaction [1 year]

      Patients will rate their overall satisfaction on a quartile grading system: 0, unsatisfied; 1, slightly satisfied; 2, satisfied; and 3, very satisfied

    4. Adverse events [1 year]

      erythema, edema, crusting, pigmentary changes, ecchymosis, and scarring, will be recorded

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine, Assiut University Assiut Egypt 71111

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mohammed Hisham Zayan, resident plastic surgery department, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05985265
    Other Study ID Numbers:
    • nano fat injection
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 14, 2023