Trial Outcomes & Findings for Pilot Study Investigating the Efficacy of Fat Grafting as a Treatment for Male and Female Facial Acne Scarring (NCT NCT04559022)
NCT ID: NCT04559022
Last Updated: 2024-10-26
Results Overview
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
COMPLETED
NA
10 participants
Baseline
2024-10-26
Participant Flow
Participant milestones
| Measure |
Fat Grafting for Acne Scar Treatment
This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
Fat Grafting: This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
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|---|---|
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Overall Study
STARTED
|
10
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|
Overall Study
COMPLETED
|
10
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|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study Investigating the Efficacy of Fat Grafting as a Treatment for Male and Female Facial Acne Scarring
Baseline characteristics by cohort
| Measure |
Fat Grafting for Acne Scar Treatment
n=10 Participants
This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
Fat Grafting: This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Fitzpatrick Skin Score
Type 1
|
0 Participants
n=5 Participants
|
|
Fitzpatrick Skin Score
Type 2
|
6 Participants
n=5 Participants
|
|
Fitzpatrick Skin Score
Type 3
|
1 Participants
n=5 Participants
|
|
Fitzpatrick Skin Score
Type 4
|
3 Participants
n=5 Participants
|
|
Fitzpatrick Skin Score
Type 5
|
0 Participants
n=5 Participants
|
|
Fitzpatrick Skin Score
Type 6
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineThe 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
Outcome measures
| Measure |
Fat Grafting for Acne Scar Treatment
n=10 Participants
This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
Fat Grafting: This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
|
Clinician Assessment
The Clinician GAIS was completed after study completion.
|
Reticular Dermis- Type I Collagen
Microbiopsies were collected at baseline and follow up visits. Analysis was used to correlate changes seen with noninvasive skin measurements and clinical assessment with histological changes in ultrastructure.
|
Reticular Dermis- Type III Collagen
Microbiopsies were collected at baseline and follow up visits. Analysis was used to correlate changes seen with noninvasive skin measurements and clinical assessment with histological changes in ultrastructure.
|
Matrix Metalloproteinase-2
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.
|
Tissue Growth Factor B1
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.
|
Tissue Growth Factor B3
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.
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|---|---|---|---|---|---|---|---|
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Subject Acne Severity Scale
Grade 1: Macular
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
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Subject Acne Severity Scale
Grade 2: Mild
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject Acne Severity Scale
Grade 3: Moderate
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
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Subject Acne Severity Scale
Grade 4: Severe
|
7 Participants
|
—
|
—
|
—
|
—
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—
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—
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PRIMARY outcome
Timeframe: Month 3 and Month 6Subjects 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. 5. Worse: The appearance is worse than the original condition.
Outcome measures
| Measure |
Fat Grafting for Acne Scar Treatment
n=10 Participants
This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
Fat Grafting: This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
|
Clinician Assessment
n=10 Participants
The Clinician GAIS was completed after study completion.
|
Reticular Dermis- Type I Collagen
Microbiopsies were collected at baseline and follow up visits. Analysis was used to correlate changes seen with noninvasive skin measurements and clinical assessment with histological changes in ultrastructure.
|
Reticular Dermis- Type III Collagen
Microbiopsies were collected at baseline and follow up visits. Analysis was used to correlate changes seen with noninvasive skin measurements and clinical assessment with histological changes in ultrastructure.
|
Matrix Metalloproteinase-2
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.
|
Tissue Growth Factor B1
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.
|
Tissue Growth Factor B3
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.
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|---|---|---|---|---|---|---|---|
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Facial Photograph Assessments- Global Aesthetic Improvement Scale
Month 3
|
2.7 units on a scale
Standard Error .36
|
3 units on a scale
Standard Error .37
|
—
|
—
|
—
|
—
|
—
|
|
Facial Photograph Assessments- Global Aesthetic Improvement Scale
Month 6
|
2.8 units on a scale
Standard Error .26
|
3.2 units on a scale
Standard Error .25
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and 6 MonthsMiraVex will be used to assess changes in texture (roughness) of the subjects facial acne scars.
Outcome measures
| Measure |
Fat Grafting for Acne Scar Treatment
n=10 Participants
This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
Fat Grafting: This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
|
Clinician Assessment
n=10 Participants
The Clinician GAIS was completed after study completion.
|
Reticular Dermis- Type I Collagen
Microbiopsies were collected at baseline and follow up visits. Analysis was used to correlate changes seen with noninvasive skin measurements and clinical assessment with histological changes in ultrastructure.
|
Reticular Dermis- Type III Collagen
Microbiopsies were collected at baseline and follow up visits. Analysis was used to correlate changes seen with noninvasive skin measurements and clinical assessment with histological changes in ultrastructure.
|
Matrix Metalloproteinase-2
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.
|
Tissue Growth Factor B1
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.
|
Tissue Growth Factor B3
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.
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|---|---|---|---|---|---|---|---|
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Topographical Analysis of Texture
Maximum Depth of Depressions (mm)
|
0.1495 mm
Standard Error 0.019
|
0.0536 mm
Standard Error 0.017
|
—
|
—
|
—
|
—
|
—
|
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Topographical Analysis of Texture
Roughness (Ra)
|
17.55 mm
Standard Error 1.5
|
16.58 mm
Standard Error 1.6
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—
|
—
|
—
|
—
|
—
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PRIMARY outcome
Timeframe: Baseline, 3 Months and 6 MonthsRelative 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.
Outcome measures
| Measure |
Fat Grafting for Acne Scar Treatment
n=10 Participants
This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
Fat Grafting: This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
|
Clinician Assessment
n=10 Participants
The Clinician GAIS was completed after study completion.
|
Reticular Dermis- Type I Collagen
n=10 Participants
Microbiopsies were collected at baseline and follow up visits. Analysis was used to correlate changes seen with noninvasive skin measurements and clinical assessment with histological changes in ultrastructure.
|
Reticular Dermis- Type III Collagen
n=10 Participants
Microbiopsies were collected at baseline and follow up visits. Analysis was used to correlate changes seen with noninvasive skin measurements and clinical assessment with histological changes in ultrastructure.
|
Matrix Metalloproteinase-2
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.
|
Tissue Growth Factor B1
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.
|
Tissue Growth Factor B3
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.
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|---|---|---|---|---|---|---|---|
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Histological Analysis
Baseline
|
1.00 percentage change from baseline
Standard Error 0.09
|
1.00 percentage change from baseline
Standard Error .25
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1.0 percentage change from baseline
Standard Error .18
|
1.0 percentage change from baseline
Standard Error .26
|
—
|
—
|
—
|
|
Histological Analysis
Month 3
|
1.07 percentage change from baseline
Standard Error 0.13
|
0.87 percentage change from baseline
Standard Error 0.24
|
0.76 percentage change from baseline
Standard Error 0.10
|
0.74 percentage change from baseline
Standard Error 0.08
|
—
|
—
|
—
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|
Histological Analysis
Month 6
|
0.85 percentage change from baseline
Standard Error 0.05
|
0.76 percentage change from baseline
Standard Error 0.15
|
0.85 percentage change from baseline
Standard Error 0.06
|
0.62 percentage change from baseline
Standard Error 0.13
|
—
|
—
|
—
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PRIMARY outcome
Timeframe: Baseline, 3 Months and 6 MonthsBiopsies 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.
Outcome measures
| Measure |
Fat Grafting for Acne Scar Treatment
n=10 Participants
This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
Fat Grafting: This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
|
Clinician Assessment
n=10 Participants
The Clinician GAIS was completed after study completion.
|
Reticular Dermis- Type I Collagen
n=10 Participants
Microbiopsies were collected at baseline and follow up visits. Analysis was used to correlate changes seen with noninvasive skin measurements and clinical assessment with histological changes in ultrastructure.
|
Reticular Dermis- Type III Collagen
n=10 Participants
Microbiopsies were collected at baseline and follow up visits. Analysis was used to correlate changes seen with noninvasive skin measurements and clinical assessment with histological changes in ultrastructure.
|
Matrix Metalloproteinase-2
n=10 Participants
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.
|
Tissue Growth Factor B1
n=10 Participants
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.
|
Tissue Growth Factor B3
n=10 Participants
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.
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|---|---|---|---|---|---|---|---|
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Gene Expression
Baseline
|
1.13 percentage change from baseline
Standard Error 0.20
|
1.21 percentage change from baseline
Standard Error 0.34
|
1.31 percentage change from baseline
Standard Error 0.49
|
1.46 percentage change from baseline
Standard Error 0.58
|
1.17 percentage change from baseline
Standard Error 0.24
|
1.19 percentage change from baseline
Standard Error 0.32
|
1.37 percentage change from baseline
Standard Error 0.55
|
|
Gene Expression
Month 3
|
1.48 percentage change from baseline
Standard Error 0.83
|
1.68 percentage change from baseline
Standard Error 1.00
|
0.45 percentage change from baseline
Standard Error 0.19
|
0.69 percentage change from baseline
Standard Error 0.32
|
0.66 percentage change from baseline
Standard Error 0.28
|
0.65 percentage change from baseline
Standard Error 0.07
|
0.40 percentage change from baseline
Standard Error 0.01
|
|
Gene Expression
Month 6
|
0.58 percentage change from baseline
Standard Error 0.13
|
0.58 percentage change from baseline
Standard Error 0.12
|
0.59 percentage change from baseline
Standard Error 0.27
|
0.53 percentage change from baseline
Standard Error 0.12
|
0.43 percentage change from baseline
Standard Error 0.12
|
0.61 percentage change from baseline
Standard Error 0.12
|
0.56 percentage change from baseline
Standard Error 0.14
|
PRIMARY outcome
Timeframe: Baseline and 6 MonthsMiraVex will be used to assess changes in depressions of the subjects facial acne scars.
Outcome measures
| Measure |
Fat Grafting for Acne Scar Treatment
n=10 Participants
This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
Fat Grafting: This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
|
Clinician Assessment
n=10 Participants
The Clinician GAIS was completed after study completion.
|
Reticular Dermis- Type I Collagen
Microbiopsies were collected at baseline and follow up visits. Analysis was used to correlate changes seen with noninvasive skin measurements and clinical assessment with histological changes in ultrastructure.
|
Reticular Dermis- Type III Collagen
Microbiopsies were collected at baseline and follow up visits. Analysis was used to correlate changes seen with noninvasive skin measurements and clinical assessment with histological changes in ultrastructure.
|
Matrix Metalloproteinase-2
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.
|
Tissue Growth Factor B1
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.
|
Tissue Growth Factor B3
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.
|
|---|---|---|---|---|---|---|---|
|
Topographical Analysis of Depressions
|
11.45 mm^3
Standard Error 2.36
|
10.64 mm^3
Standard Error 2.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 3 and Month 6Transepidermal Water Loss (TEWL) was measured at baseline and 6 months after treatment.
Outcome measures
| Measure |
Fat Grafting for Acne Scar Treatment
n=10 Participants
This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
Fat Grafting: This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
|
Clinician Assessment
n=10 Participants
The Clinician GAIS was completed after study completion.
|
Reticular Dermis- Type I Collagen
Microbiopsies were collected at baseline and follow up visits. Analysis was used to correlate changes seen with noninvasive skin measurements and clinical assessment with histological changes in ultrastructure.
|
Reticular Dermis- Type III Collagen
Microbiopsies were collected at baseline and follow up visits. Analysis was used to correlate changes seen with noninvasive skin measurements and clinical assessment with histological changes in ultrastructure.
|
Matrix Metalloproteinase-2
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.
|
Tissue Growth Factor B1
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.
|
Tissue Growth Factor B3
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.
|
|---|---|---|---|---|---|---|---|
|
Noninvasive Skin Assessments- TEWL
|
8.74 percentage change from baseline
Standard Deviation 3.41
|
35.37 percentage change from baseline
Standard Deviation 11.18
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 3 and Month 6Ultrasonography was used to measure epidermal/dermal thickness/density 3 and 6 months after treatment. Percent change from baseline results are reflected.
Outcome measures
| Measure |
Fat Grafting for Acne Scar Treatment
n=10 Participants
This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
Fat Grafting: This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
|
Clinician Assessment
n=10 Participants
The Clinician GAIS was completed after study completion.
|
Reticular Dermis- Type I Collagen
Microbiopsies were collected at baseline and follow up visits. Analysis was used to correlate changes seen with noninvasive skin measurements and clinical assessment with histological changes in ultrastructure.
|
Reticular Dermis- Type III Collagen
Microbiopsies were collected at baseline and follow up visits. Analysis was used to correlate changes seen with noninvasive skin measurements and clinical assessment with histological changes in ultrastructure.
|
Matrix Metalloproteinase-2
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.
|
Tissue Growth Factor B1
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.
|
Tissue Growth Factor B3
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.
|
|---|---|---|---|---|---|---|---|
|
Noninvasive Skin Assessments- High-resolution Ultrasonography
Epidermal Thickness
|
-4.28 percentage change from baseline
Standard Deviation 12.37
|
-0.63 percentage change from baseline
Standard Deviation 10.98
|
—
|
—
|
—
|
—
|
—
|
|
Noninvasive Skin Assessments- High-resolution Ultrasonography
Epidermal Density
|
21.34 percentage change from baseline
Standard Deviation 22.05
|
-2.9 percentage change from baseline
Standard Deviation 11.96
|
—
|
—
|
—
|
—
|
—
|
|
Noninvasive Skin Assessments- High-resolution Ultrasonography
Dermal Thickness
|
-26.4 percentage change from baseline
Standard Deviation 212.46
|
-19.4 percentage change from baseline
Standard Deviation 330.59
|
—
|
—
|
—
|
—
|
—
|
|
Noninvasive Skin Assessments- High-resolution Ultrasonography
Dermal Density
|
53.5 percentage change from baseline
Standard Deviation 11.248
|
-12.9 percentage change from baseline
Standard Deviation 5.41
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 3 and Month 6biomechanical 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.
Outcome measures
| Measure |
Fat Grafting for Acne Scar Treatment
n=10 Participants
This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
Fat Grafting: This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
|
Clinician Assessment
n=10 Participants
The Clinician GAIS was completed after study completion.
|
Reticular Dermis- Type I Collagen
Microbiopsies were collected at baseline and follow up visits. Analysis was used to correlate changes seen with noninvasive skin measurements and clinical assessment with histological changes in ultrastructure.
|
Reticular Dermis- Type III Collagen
Microbiopsies were collected at baseline and follow up visits. Analysis was used to correlate changes seen with noninvasive skin measurements and clinical assessment with histological changes in ultrastructure.
|
Matrix Metalloproteinase-2
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.
|
Tissue Growth Factor B1
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.
|
Tissue Growth Factor B3
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.
|
|---|---|---|---|---|---|---|---|
|
Noninvasive Skin Assessments- Skin Deformation
Skin Laxity
|
-5.88 percentage change from baseline
Standard Deviation 0.33
|
-5.16 percentage change from baseline
Standard Deviation 0.36
|
—
|
—
|
—
|
—
|
—
|
|
Noninvasive Skin Assessments- Skin Deformation
Skin Elasticity
|
7.36 percentage change from baseline
Standard Deviation 0.18
|
-5.62 percentage change from baseline
Standard Deviation 0.34
|
—
|
—
|
—
|
—
|
—
|
|
Noninvasive Skin Assessments- Skin Deformation
Viscoelastic Deformation
|
3.57 percentage change from baseline
Standard Deviation 0.03
|
2.38 percentage change from baseline
Standard Deviation 0.34
|
—
|
—
|
—
|
—
|
—
|
|
Noninvasive Skin Assessments- Skin Deformation
Ultimate Deformation
|
-6.90 percentage change from baseline
Standard Deviation 0.25
|
-11.61 percentage change from baseline
Standard Deviation 0.35
|
—
|
—
|
—
|
—
|
—
|
|
Noninvasive Skin Assessments- Skin Deformation
Stiffness
|
-1.53 percentage change from baseline
Standard Deviation 46.22
|
4.05 percentage change from baseline
Standard Deviation 49.68
|
—
|
—
|
—
|
—
|
—
|
|
Noninvasive Skin Assessments- Skin Deformation
Energy Absorption
|
-2.35 percentage change from baseline
Standard Deviation 11.30
|
-6.07 percentage change from baseline
Standard Deviation 0.820
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Fat Grafting for Acne Scar Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fat Grafting for Acne Scar Treatment
n=10 participants at risk
This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
Fat Grafting: This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
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General disorders
Covid
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10.0%
1/10 • Number of events 1 • 18 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place