Trial Outcomes & Findings for Radio Frequency Microneedling for Suprapatellar Skin (NCT NCT03507036)

NCT ID: NCT03507036

Last Updated: 2020-12-03

Results Overview

Photographs will be used to evaluate efficacy of treatment. The photographs from final visit will be compared to their baseline photographs and visually evaluated by the study team. The study team will assess the laxity from baseline to 6 months.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: baseline and 6 months
• Results posted on: 2020-12-03

Participant Flow

Participant milestones

Measure	Treatment All patients will undergo treatment with Profound system device (bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis). Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression.
Overall Study STARTED	20
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radio Frequency Microneedling for Suprapatellar Skin

Baseline characteristics by cohort

Measure	Treatment n=15 Participants All patients will undergo treatment with Profound system device (bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis). Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	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	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Population: Reviewers were asked to evaluate the visible change in texture and laxity on a scale of 1-3. Worsened (1), No Change (2) and Improved (3).

Photographs will be used to evaluate efficacy of treatment. The photographs from final visit will be compared to their baseline photographs and visually evaluated by the study team. The study team will assess the laxity from baseline to 6 months.

Outcome measures

Measure	Treatment n=15 Participants All patients will undergo treatment with Profound system device. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression.
Photographic Knee Laxity and Texture Evaluation Texture	1.87 score on a scale Standard Deviation 0.52
Photographic Knee Laxity and Texture Evaluation Laxity	2.02 score on a scale Standard Deviation 0.52

PRIMARY outcome

Timeframe: baseline, 7 Days, 3 Weeks, 3 Months and 6 Months

Skin Elasticity will be measured via BTC2000 prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment. The change from baseline was calculated at each time frame.

Outcome measures

Measure	Treatment n=15 Participants All patients will undergo treatment with Profound system device. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression.
Epidermal Thickness Baseline	96.53333 mm Standard Deviation 10.2578
Epidermal Thickness 7 Days	106.9 mm Standard Deviation 24.0632
Epidermal Thickness 3 Weeks	98.33333 mm Standard Deviation 16.3524
Epidermal Thickness 3 Months	92.36667 mm Standard Deviation 9.55739
Epidermal Thickness 6 Months	91.36667 mm Standard Deviation 12.1414

PRIMARY outcome

Timeframe: Baseline, 7 Days, 3 Weeks, 3 Months and 6 Months

Dermal thickness will be masured via high resolution ultrasound prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment. The change from baseline was calculated at each time frame.

Outcome measures

Measure	Treatment n=15 Participants All patients will undergo treatment with Profound system device. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression.
Dermal Thickness Month 3	1167.933 mm Standard Deviation 150.659
Dermal Thickness Month 6	1122.233 mm Standard Deviation 200.07
Dermal Thickness Baseline	1104.7 mm Standard Deviation 192.626
Dermal Thickness Day 7	1179.2 mm Standard Deviation 177.83
Dermal Thickness Week 3	1241.367 mm Standard Deviation 191.049

PRIMARY outcome

Timeframe: Baseline, Day 7, Week 3 Month 3 and Month 6

Population: Results at each visit show the change from baseline values.

Blood Flow will be measured via optical coherence tomography prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment.

Outcome measures

Measure	Treatment n=15 Participants All patients will undergo treatment with Profound system device. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression.
Change in Blood Flow at 0.25mm Baseline	0.3294 mm/s Standard Deviation 0.009815
Change in Blood Flow at 0.25mm Day 7	0.23 mm/s Standard Deviation 0.41
Change in Blood Flow at 0.25mm Week 3	-0.02 mm/s Standard Deviation 0.37
Change in Blood Flow at 0.25mm Month 3	0.080534 mm/s Standard Deviation 0.33661
Change in Blood Flow at 0.25mm Month 6	0.1045 mm/s Standard Deviation 0.3411

PRIMARY outcome

Timeframe: Baseline, Day 7, Week 3, Month 3 and Month 6

Transepidermal Water Loss will be masured via Aquaflux prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment. The change from baseline was calculated at each time frame.

Outcome measures

Measure	Treatment n=15 Participants All patients will undergo treatment with Profound system device. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression.
Transepidermal Water Loss Baseline	9.379 g/(m2h) Standard Deviation 2.05288
Transepidermal Water Loss Day 7	9.6007 g/(m2h) Standard Deviation 2.1681
Transepidermal Water Loss Week 3	10.9986 g/(m2h) Standard Deviation 3.9201
Transepidermal Water Loss Month 3	11.744 g/(m2h) Standard Deviation 8.7825
Transepidermal Water Loss Month 6	8.772 g/(m2h) Standard Deviation 1.966

PRIMARY outcome

Timeframe: Baseline, Day 7, Week 3, Months 3 and Months 6

Skin Elasticity will be measured via BTC2000 prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment. The change from baseline was calculated at each time frame.

Outcome measures

Measure	Treatment n=15 Participants All patients will undergo treatment with Profound system device. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression.
Skin Elasticity Baseline	0.80199 mm Standard Deviation 0.1263
Skin Elasticity Day 7	0.811731094 mm Standard Deviation 0.256170747
Skin Elasticity Week 3	0.82434 mm Standard Deviation 0.1549
Skin Elasticity Month 3	0.77234 mm Standard Deviation 0.11494
Skin Elasticity Month 6	0.74615 mm Standard Deviation 0.11275

PRIMARY outcome

Timeframe: baseline, 7 days, 3 weeks, 3 months and 6 months

Population: Results at each visit show the change from baseline values.

BTC2000 will be used to measure skin laxity prior to treatment and post treatment. The BTC2000 is a non-invasive device that measures skin laxity by creating a negative pressure against the skin and calculates laxity when the pressure is released.

Outcome measures

Measure	Treatment n=15 Participants All patients will undergo treatment with Profound system device. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression.
Change in Skin Laxity Baseline	0.7408 mm Standard Deviation 0.1200845
Change in Skin Laxity Day 7	12.5364 mm Standard Deviation 27.762
Change in Skin Laxity Week 3	3.75791 mm Standard Deviation 21.921
Change in Skin Laxity Month 3	0.85623 mm Standard Deviation 21.253
Change in Skin Laxity Month 6	-5.54778 mm Standard Deviation 16.383

PRIMARY outcome

Timeframe: Baseline. Day 7 and 3 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.

Outcome measures

Measure	Treatment n=15 Participants All patients will undergo treatment with Profound system device. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression.
Histological Analysis- Collagen 1 Baseline	1.38 fluorescence intensity Standard Deviation 0.51
Histological Analysis- Collagen 1 Day 7	1.00 fluorescence intensity Standard Deviation 0.23
Histological Analysis- Collagen 1 Month 3	1.04 fluorescence intensity Standard Deviation 0.23

PRIMARY outcome

Timeframe: Day 7, Month 3

Population: Results at each visit show the change from baseline values.

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. Fold change was calculated at each time point past baseline.

Fold change = sample/average of the baseline.

Outcome measures

Measure	Treatment n=15 Participants All patients will undergo treatment with Profound system device. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression.
Gene Expression- Collagen 1 Day 7	1.91 fold change Standard Error 1.68
Gene Expression- Collagen 1 Month 3	1.38 fold change Standard Error 0.57

PRIMARY outcome

Timeframe: Baseline, Day 7, Week 3, Month 3 and Month 6

Epidermal thickness will be masured via high resolution ultrasound prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment. The change from baseline was calculated at each time frame.

Outcome measures

Measure	Treatment n=15 Participants All patients will undergo treatment with Profound system device. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression.
Epidermal Density Baseline	0.00380558 um Standard Deviation 0.000635
Epidermal Density Day 7	0.028518 um Standard Deviation 0.09374
Epidermal Density Week 3	0.004336 um Standard Deviation 0.00232
Epidermal Density Month 3	0.020107 um Standard Deviation 0.08714
Epidermal Density Month 6	0.00392152 um Standard Deviation 2.783

PRIMARY outcome

Timeframe: Baseline, Day 7, Month 3

Population: Results at each visit show the change from baseline values.

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. Sample/Average of the baseline.

Outcome measures

Measure	Treatment n=15 Participants All patients will undergo treatment with Profound system device. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression.
Histological Analysis- Collagen 3 Baseline	0.63 fluorescence intensity Standard Deviation 0.17
Histological Analysis- Collagen 3 Day 7	0.72 fluorescence intensity Standard Deviation 0.18
Histological Analysis- Collagen 3 Month 3	0.71 fluorescence intensity Standard Deviation 0.28

PRIMARY outcome

Timeframe: Baseline, Day 7, Month 3

Population: Results at each visit show the change from baseline values.

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. Samples/Average of the baseline

Outcome measures

Measure	Treatment n=15 Participants All patients will undergo treatment with Profound system device. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression.
Histological Analysis- Elastin Baseline	1.29 fluorescence intensity Standard Deviation 0.24
Histological Analysis- Elastin Day 7	0.90 fluorescence intensity Standard Deviation 0.50
Histological Analysis- Elastin Month 3	0.58 fluorescence intensity Standard Deviation 0.17

PRIMARY outcome

Timeframe: Day 7, Month 3

Population: Results at each visit show the change from baseline values.

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.

Fold change = sample/average of the baseline.

Outcome measures

Measure	Treatment n=15 Participants All patients will undergo treatment with Profound system device. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression.
Gene Expression- Collagen 3 Day 7	2.07 fold change Standard Error 1.68
Gene Expression- Collagen 3 Month 3	1.36 fold change Standard Error 0.96

PRIMARY outcome

Timeframe: Day 7, Month 3

Population: Results at each visit show the change from baseline values.

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.

Fold change = sample/average of the baseline.

Outcome measures

Measure	Treatment n=15 Participants All patients will undergo treatment with Profound system device. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression.
Gene Expression- Elastin Day 7	0.89 fold change Standard Error 0.41
Gene Expression- Elastin Month 3	1.74 fold change Standard Error 1.37

PRIMARY outcome

Timeframe: Day 7, Month 3

Population: Results at each visit show the change from baseline values.

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.

Fold change = sample/average of the baseline.

Outcome measures

Measure	Treatment n=15 Participants All patients will undergo treatment with Profound system device. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression.
Gene Expression- Interluekin 6 Day 7	18.60 fold change Standard Error 13.37
Gene Expression- Interluekin 6 Month 3	4.04 fold change Standard Error 4.78

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment n=15 participants at risk All patients will undergo treatment with Profound system device (microneedles and thermal heat to stimulate neocollagenesis). Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression.
Skin and subcutaneous tissue disorders Tenderness	6.7% 1/15 • Number of events 1 • 6 Months
Skin and subcutaneous tissue disorders Tingling Sensation	6.7% 1/15 • 6 Months
Respiratory, thoracic and mediastinal disorders Laryngitis	6.7% 1/15 • Number of events 1 • 6 Months
Skin and subcutaneous tissue disorders Swelling on the knee	13.3% 2/15 • Number of events 2 • 6 Months
Skin and subcutaneous tissue disorders Blistering	6.7% 1/15 • Number of events 1 • 6 Months
Skin and subcutaneous tissue disorders Hyperpigmentation	13.3% 2/15 • Number of events 2 • 6 Months

Additional Information

Jennifer Barillas

UT Southwestern

Phone: 214-645-8907

Email: jennifer.barillas@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place