NCT05985265

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2022

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2024

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

November 15, 2022

Last Update Submit

August 8, 2023

Conditions

Outcome Measures

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

    up to 24 weeks

Secondary Outcomes (4)

  • Physician global assessment

    up to 24 weeks

  • percent of reduction in scar count

    up to 24 weeks

  • Patient satisfaction

    1 year

  • Adverse events

    1 year

Study Arms (1)

Nano fat grafting and fractional carbon dioxide laser resurfacing

EXPERIMENTAL

treating of atrophic acne scars with nano fat and fractional carbon dioxide laser

Procedure: Fat grafting

Interventions

Fat graftingPROCEDURE

Nano fat grafting followed by fractional carbon dioxide laser resurfacing

Also known as: fractional carbon dioxide laser resurfacing
Nano fat grafting and fractional carbon dioxide laser resurfacing

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Assiut University

Asyut, 71111, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 17199653BACKGROUND
  • 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 Officials

  • youssef S farrag, MD

    Department of Plastic Surgery, professor

    PRINCIPAL INVESTIGATOR
  • Wael S Ibraheem, MD

    Department of Plastic Surgery , Assistant lecture

    PRINCIPAL INVESTIGATOR

Central Study Contacts

mohammed H Abdelhafez, MBBS

CONTACT

sara M Awad, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident plastic surgery department

Study Record Dates

First Submitted

November 15, 2022

First Posted

August 14, 2023

Study Start

September 1, 2023

Primary Completion

April 29, 2024

Study Completion

May 29, 2024

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations