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Not yet recruitingNCT05985265Updated Aug 14, 2023

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

An interventional study of Fat grafting in Acne Scars - Atrophic, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
16 Years to 50 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Acne Scars - Atrophic

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03

In context

Atrophy

828 studies on the registry are indexed under Atrophy; 122 are open to participants now.

This study's planned enrollment of 50 is above the median of 34 across 603 interventional studies indexed under Atrophy.

Browse Atrophy studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 50 Years
Sexes eligible
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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureFat grafting

    Nano fat grafting followed by fractional carbon dioxide laser resurfacing

    Also known as: fractional carbon dioxide laser resurfacing

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 24 weeks

Secondary outcomes

  1. 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.

    Time frame: up to 24 weeks

  2. 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

    Time frame: up to 24 weeks

  3. Patient satisfaction

    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

  4. Adverse events

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

    Time frame: 1 year

07

Study locations

1 site
  • Faculty of Medicine, Assiut University
    Assiut, 71111, Egypt
08

References and documents

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. PubMed 17199653 ↗
  • 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. PubMed 11423843 ↗
  • 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. PubMed 20976801 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05985265
Lead sponsor
Assiut University
Responsible party
Mohammed Hisham Zayan (resident plastic surgery department, Assiut University) — Principal investigator
First posted
Aug 14, 2023
Start date
Sep 1, 2023 (estimated)
Primary completion
Apr 29, 2024 (estimated)
Completion
May 29, 2024 (estimated)
Last update
Aug 14, 2023

Study contacts

mohammed H Abdelhafez, MBBS
Contact
Dr.m.zayan@gmail.com
+201099068855
sara M Awad, MD
Contact
saramawad@gmail.com
+201023102094
youssef S farrag, MD
principal investigator · Department of Plastic Surgery, professor
Wael S Ibraheem, MD
principal investigator · Department of Plastic Surgery , Assistant lecture

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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