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HyperpigmentationNCT06103461

Fat Grafting an Ideal Filler For Contour Deformities With Hyperpigmentation On Face

A study testing Autologous fat grafting in people with Hyperpigmentation, run by King Edward Medical University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Hyperpigmentation
What is being tested?
Autologous fat grafting
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 sitePakistan
Study dates
22 Feb 2022to 21 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Pigmentation with contour defect

Who cannot join

  • Unfit for anesthesia

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • King Edward Medical University

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

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

Read the detailed description

Introduction Facial contour defects need augmentation have pigmentary issues related to them. Such defects are noticed after trauma, autoimmune disease or after infection. These combined contour and pigmentary defects cause social as well as aesthetic concerns. Discolored skin makes them more prominent. Conventionally, fillers are employed but these are short lived at one hand while do not treat pigmentation on the other hand. Body tissues in the form of flaps have also been tried but with the same outcome as with the fillers. Lasers and chemical depigmentation improve skin color but has to do nothing with filling of the contour. In short so far, no single satisfactory remedy is available for such issues. Therefore, some innovative strategy is needed which can fill contour defect and resolves pigmentation too.

Adipose tissue, being autologous, is a pronounced source with regenerative potential as well as natural augmentation. Due to its abundance, easy harvesting and pliability at recipient site make it ideal. Filling effect is just one aspect rather grafted fat not only softens scars, rejuvenates skin but also improves pigmentation. Therefore, in our study we aimed at the evaluation of fat as an ideal filler.

Materials and Methods This prospective study was conducted in Plastic \& Reconstructive Surgery Department of KEMU Lahore from Feb 2022 to Feb 2023. Hundred patients of both genders and age between 10 to 50 years having contour defects on face were recruited.

Patients having rejuvenation procedure like filler, laser, depigmentation or PRP done were excluded from the study. Biodata along with deformity details were noted. Advantages, limitations and likely complications related to the procedure were explained and informed consent was documented.

Pre-procedure skin texture, color and defect was noted. Donor area was marked and local anesthesia with 0.5% Xylocain and 1:500,000 Adrenaline in normal saline was infiltrated with one milliliter of fluid for one milliliter of fat to be procured. Fat was procured with blunt 2-mm multi-hole cannula using 10cc Luer-Lok syringe under manual suction applied not more than 2ml. Then fat was transferred to recipient area by using Icc syringe and infiltration canula till symmetry achieved with contralateral respective area of face. Grafted area photographed and integrated color density (ICD1) was found with ImageJ. All patients were observed for 24 hours to look for any complication. Oral analgesic and antibiotics were prescribed for 3 days. Patients were kept under monthly follow up and sessions were repeated if required (13). Subjective as well as objective measurement of outcomes was done. For objective evaluation, repeat photograph was taken after one year of deformity got resolved. Integrated color density (ICD2) was again measured and compared with ICD1. For subjective evaluation, patient's was noted.

Findings were recorded and variables like age, gender, area involved, duration, ICD and satisfaction documented. SPSS 22 used for data analysis with p- Value <0.05 considered significant.

Being tested
Autologous fat grafting
Keywords
Pigmentation, Contour defect, Fat grafting
Medical subject headings
Hyperpigmentation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous fat graftingProcedure or surgery

    Autologous fat grafted at contour defects with pigmentary changes

Study groups in NCT06103461
Study groupRoleWhat they receive
Fat GraftingExperimentalIt is an experimental study for effect of fat grafting on pigmentation of skin
Receives: Procedure: Autologous fat grafting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IDC

    integrated color density

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2023
  2. Study start22 Feb 2022
  3. Primary completion21 Feb 2023
  4. Study completion21 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Cohort study
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06103461
Sponsor's protocol ID
kemu/23/1
Status last verified
Oct 2023
First submitted
21 Oct 2023
Last updated
26 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Statistical data to be shared

Questions about this trial

What is this clinical trial studying?

A study testing Autologous fat grafting in people with Hyperpigmentation, run by King Edward Medical University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IDC (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.

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