NCT06103461

Brief Summary

Pigmentary changes are commonly associated with contour defects of facial region. These deformities cause cosmetic concerns. Traditionally used techniques indwelling limitations and therefore it invokes innovative techniques to treat contour abrasion and pigmentation simultaneously. The current study focuses on evaluation of the role of autologous fat in improving contour defects of face associated with hyperpigmentation. 100 subjects having contour defects related skin pigmentation were recruited from Feb 2022 till Feb 2023. Fat was harvested, processed under sterilized conditions and grafted into the affected regions of face. The patients were kept under follow up for one year after fat injection. Subjective as well as objective evaluation was done before treatment and one year after fat injection. Results showed significant improvement in pigmentation after fat injection. Most of the patients had high satisfaction regarding improvement in pigmentation and pliability of the grafted area after use of fat graft. A software Image J was applied to objectively showing changes in hyperpigmentation of face after fat graft. In conclusion, utility of autologous fat has effective and promising role as an ideal filler for treating contour defects of face with pigmentary changes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 22, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

12 months

First QC Date

October 21, 2023

Last Update Submit

October 25, 2023

Conditions

Keywords

PigmentationContour defectFat grafting

Outcome Measures

Primary Outcomes (1)

  • IDC

    integrated color density

    6 Months

Study Arms (1)

Fat Grafting

EXPERIMENTAL

It is an experimental study for effect of fat grafting on pigmentation of skin

Procedure: Autologous fat grafting

Interventions

Autologous fat grafted at contour defects with pigmentary changes

Fat Grafting

Eligibility Criteria

Age10 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pigmentation with contour defect

You may not qualify if:

  • Unfit for anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Afzaal Bashir, FACS, MS

    King Edward Medical University, Lahore, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Cohort study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 21, 2023

First Posted

October 26, 2023

Study Start

February 22, 2022

Primary Completion

February 21, 2023

Study Completion

February 21, 2023

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Statistical data to be shared

Locations