NCT04559022 is a NA clinical trial of Fat Grafting in Acne Scars - Mixed Atrophic and Hypertrophic, sponsored by University of Texas Southwestern Medical Center.

Who is sponsoring NCT04559022?

NCT04559022 is sponsored by University of Texas Southwestern Medical Center.

What drugs are being tested in NCT04559022?

Interventions in NCT04559022: Fat Grafting.

What condition does NCT04559022 study?

NCT04559022 studies Acne Scars - Mixed Atrophic and Hypertrophic, Acne.

Is NCT04559022 still recruiting?

NCT04559022 is currently completed. Last updated 26 October 2024.

Are results published for NCT04559022?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-10-26 · How we verify

NCT04559022

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pilot Study Investigating the Efficacy of Fat Grafting as a Treatment for Male and Female Facial Acne Scarring

Completed NA Results posted Last updated 26 October 2024

What this trial tests

NA trial testing Fat Grafting in Acne Scars - Mixed Atrophic and Hypertrophic in 10 participants. Completed in 14 December 2022.

Timeline

30 October 2020

Primary endpoint
10 June 2022

14 December 2022

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	30 October 2020
Primary completion	10 June 2022
Estimated completion	14 December 2022
Sites	1 location across United States

Drugs / interventions tested

Fat Grafting

Conditions studied

Acne Scars - Mixed Atrophic and Hypertrophic — all drugs for Acne Scars - Mixed Atrophic and Hypertrophic →
Acne — all drugs for Acne →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 18 to 50, any sex, with Acne Scars - Mixed Atrophic and Hypertrophic or Acne. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Subject Acne Severity Scale Primary · Baseline

The Goodman and Baron Qualitative Acne Scale will be used to assess acne scars. Grade 1- Macular Disease: Erythematous, hyper- or hypopigmented flat marks Grade 2- Mild Disease: Mild rolling, small soft papular Grade 3- Moderate Disease: More significant rolling, shallow "box car", mild to moderate hypertrophic or papular scars Garde 4- Severe disease: Punched out atrophic, "ice pick", bridges and tunnels, gross atrophy, dystrophic, scars significant hypertrophy or keloid

Grade 1: Macular

Group	Value	95% CI
Fat Grafting for Acne Scar Treatment	0

Grade 2: Mild

Group	Value	95% CI
Fat Grafting for Acne Scar Treatment	1

Grade 3: Moderate

Group	Value	95% CI
Fat Grafting for Acne Scar Treatment	2

Grade 4: Severe

Group	Value	95% CI
Fat Grafting for Acne Scar Treatment	7

Facial Photograph Assessments- Global Aesthetic Improvement Scale Primary · Month 3 and Month 6

Subjects and Clinicians will evaluate efficacy of treatment at follow up visits. The photographs from follow up visits will be compared to their baseline photographs. Acne scars on patients will be assessed using the Global Aesthetic Improvement Scale by subject and clinician. CGAIS Rating 1. Very much improved: Optimal cosmetic result. 2. Much improved: Marked improvement in appearance from the initial condition, but not completely optimal. 3. Improved: Obvious improvement in appearance from initial condition. 4. No Change: The appearance is essentially the same as the original condition.

Month 3

Group	Value	95% CI
In Person Subject Assessment	2.7	± .36
Clinician Assessment	3	± .37

Month 6

Group	Value	95% CI
In Person Subject Assessment	2.8	± .26
Clinician Assessment	3.2	± .25

Topographical Analysis of Texture Primary · Baseline and 6 Months

MiraVex will be used to assess changes in texture (roughness) of the subjects facial acne scars.

Maximum Depth of Depressions (mm)

Group	Value	95% CI
Baseline	0.1495	± 0.019
Month 6	0.0536	± 0.017

Roughness (Ra)

Group	Value	95% CI
Baseline	17.55	± 1.5
Month 6	16.58	± 1.6

Histological Analysis Primary · Baseline, 3 Months and 6 Months

Relative changes in protein abundance in biopsies taken at post treatment compare to control or entreated group will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline was calculated at each time frame.

Baseline

Group	Value	95% CI
Papillary Dermis- Type I Collagen	1.00	± 0.09
Papillary Dermis- Type III Collagen	1.00	± .25
Reticular Dermis- Type I Collagen	1.0	± .18
Reticular Dermis- Type III Collagen	1.0	± .26

Month 3

Group	Value	95% CI
Papillary Dermis- Type I Collagen	1.07	± 0.13
Papillary Dermis- Type III Collagen	0.87	± 0.24
Reticular Dermis- Type I Collagen	0.76	± 0.10
Reticular Dermis- Type III Collagen	0.74	± 0.08

Month 6

Group	Value	95% CI
Papillary Dermis- Type I Collagen	0.85	± 0.05
Papillary Dermis- Type III Collagen	0.76	± 0.15
Reticular Dermis- Type I Collagen	0.85	± 0.06
Reticular Dermis- Type III Collagen	0.62	± 0.13

Gene Expression Primary · Baseline, 3 Months and 6 Months

Biopsies of the treated are will be taken prior to treatment and post treatment for gene expression analysis. This analysis will identify gene expression related to collagen formation and increased cell turnover.

Baseline

Group	Value	95% CI
Type 1 Collagen	1.13	± 0.20
Type III Collagen	1.21	± 0.34
Elastin	1.31	± 0.49
Lysl Oxidase	1.46	± 0.58
Matrix Metalloproteinase-2	1.17	± 0.24
Tissue Growth Factor B1	1.19	± 0.32
Tissue Growth Factor B3	1.37	± 0.55

Month 3

Group	Value	95% CI
Type 1 Collagen	1.48	± 0.83
Type III Collagen	1.68	± 1.00
Elastin	0.45	± 0.19
Lysl Oxidase	0.69	± 0.32
Matrix Metalloproteinase-2	0.66	± 0.28
Tissue Growth Factor B1	0.65	± 0.07
Tissue Growth Factor B3	0.40	± 0.01

Month 6

Group	Value	95% CI
Type 1 Collagen	0.58	± 0.13
Type III Collagen	0.58	± 0.12
Elastin	0.59	± 0.27
Lysl Oxidase	0.53	± 0.12
Matrix Metalloproteinase-2	0.43	± 0.12
Tissue Growth Factor B1	0.61	± 0.12
Tissue Growth Factor B3	0.56	± 0.14

Noninvasive Skin Assessments- TEWL Secondary · Month 3 and Month 6

Transepidermal Water Loss (TEWL) was measured at baseline and 6 months after treatment.

Group	Value	95% CI
3-Month Follow Up	8.74	± 3.41
6-Month Follow Up	35.37	± 11.18

Noninvasive Skin Assessments- High-resolution Ultrasonography Secondary · Month 3 and Month 6

Ultrasonography was used to measure epidermal/dermal thickness/density 3 and 6 months after treatment. Percent change from baseline results are reflected.

Epidermal Thickness

Group	Value	95% CI
3-Month Follow Up	-4.28	± 12.37
6-Month Follow Up	-0.63	± 10.98

Epidermal Density

Group	Value	95% CI
3-Month Follow Up	21.34	± 22.05
6-Month Follow Up	-2.9	± 11.96

Dermal Thickness

Group	Value	95% CI
3-Month Follow Up	-26.4	± 212.46
6-Month Follow Up	-19.4	± 330.59

Dermal Density

Group	Value	95% CI
3-Month Follow Up	53.5	± 11.248
6-Month Follow Up	-12.9	± 5.41

Noninvasive Skin Assessments- Skin Deformation Secondary · Month 3 and Month 6

biomechanical analysis of skin deformation was used to measure skin laxity, skin elasticity, viscoelastic deformation, ultimate deformation, stiffness and energy absorption at 3 and 6 months after treatment. Percent change from baseline results are reflected.

Skin Laxity

Group	Value	95% CI
3-Month Follow Up	-5.88	± 0.33
6-Month Follow Up	-5.16	± 0.36

Skin Elasticity

Group	Value	95% CI
3-Month Follow Up	7.36	± 0.18
6-Month Follow Up	-5.62	± 0.34

Viscoelastic Deformation

Group	Value	95% CI
3-Month Follow Up	3.57	± 0.03
6-Month Follow Up	2.38	± 0.34

Ultimate Deformation

Group	Value	95% CI
3-Month Follow Up	-6.90	± 0.25
6-Month Follow Up	-11.61	± 0.35

Stiffness

Group	Value	95% CI
3-Month Follow Up	-1.53	± 46.22
6-Month Follow Up	4.05	± 49.68

Energy Absorption

Group	Value	95% CI
3-Month Follow Up	-2.35	± 11.30
6-Month Follow Up	-6.07	± 0.820

Topographical Analysis of Depressions Primary · Baseline and 6 Months

MiraVex will be used to assess changes in depressions of the subjects facial acne scars.

Group	Value	95% CI
Baseline	11.45	± 2.36
Month 6	10.64	± 2.4

Adverse events — posted to ClinicalTrials.gov

Time frame: 18 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Fat Grafting for Acne Scar Treatment

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (1 terms — click to expand)

Reaction	System	Fat Grafting for Acne Scar…
Covid	General disorders	—

Data from ClinicalTrials.gov NCT04559022 adverse events section.

Sponsor's own description

This single-center, clinical trial consists of a one autologous fat grafting treatment followed by 3-month and 6-month post-treatment visits in order to assess the efficacy of fat grafting when used by men and women with facial acne scars.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Clinical Measurement of Transepidermal Water Loss.
Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148

Verify or expand the search:

Other trials of Fat Grafting

Trials testing the same drug.

NCT05028283 — Treatment of Atrophic Post Acne Scars by Fat Grafting · NA · completed
NCT02267187 — Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material · NA · completed

Other recruiting trials for Acne Scars - Mixed Atrophic and Hypertrophic

Currently open trials in the same condition.

NCT06868615 — AVAVA MIRIA General Use · NA · recruiting
NCT06557434 — AV-23-001 AVAVA MIRIA Pilot Study · NA · active not recruiting
NCT05597267 — The MIRIA Acne Scar Study · NA · active not recruiting

Other University of Texas Southwestern Medical Center trials

Trials by the same sponsor.

NCT03849963 — Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain · recruiting
NCT06917183 — Developing Strategies for Implementation and Use of the Operating Room Black Box (ORBB) · NA · not yet recruiting
NCT05145309 — Value of Potassium Magnesium Citrate in Preventing and Treating Hypertension in African Americans · Phase 2 · not yet recruiting
NCT06552000 — Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer · NA · not yet recruiting
NCT07387666 — Imaging Acetadote Metabolism in Glioblastoma · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04559022 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
Last refreshed: 26 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04559022.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04559022

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Fat Grafting

Other recruiting trials for Acne Scars - Mixed Atrophic and Hypertrophic

Other University of Texas Southwestern Medical Center trials

Verify against primary sources