Trial Outcomes & Findings for Fractionated 1927nm Laser for Hyperpigmentation in Fitzpatrick Skin Phototypes V and VI (NCT NCT05493280)
NCT ID: NCT05493280
Last Updated: 2025-12-15
Results Overview
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of left side of face Count= the number if individual features detected in the region of interest.
COMPLETED
NA
15 participants
Baseline, 1 Month and 3 Months
2025-12-15
Participant Flow
Out of 10 subjects who completed Part 1 (Pre-Treatment Group), only 6 continued to washout and Part 2 portion of this study and thus additional subjects were enrolled in part 2 (Post-Treatment Group) as represented in the data table below.
Participant milestones
| Measure |
Healthy Subjects: First Pre-Treatment Only(Part 1), then Post-Treatment Only(Part 2) after washout
Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care.
Subjects will wash out of any topical medications for at least 6 weeks.
Part 2: Care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
Healthy Participants: Post-Treatment- Part 2 Only
Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|---|
|
Part 1 Intervention (7 months)
STARTED
|
12
|
0
|
|
Part 1 Intervention (7 months)
COMPLETED
|
10
|
0
|
|
Part 1 Intervention (7 months)
NOT COMPLETED
|
2
|
0
|
|
Washout Period (1 month)
STARTED
|
6
|
0
|
|
Washout Period (1 month)
COMPLETED
|
6
|
0
|
|
Washout Period (1 month)
NOT COMPLETED
|
0
|
0
|
|
Part 2 intervention (7 months)
STARTED
|
6
|
3
|
|
Part 2 intervention (7 months)
COMPLETED
|
5
|
3
|
|
Part 2 intervention (7 months)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Healthy Subjects: First Pre-Treatment Only(Part 1), then Post-Treatment Only(Part 2) after washout
Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care.
Subjects will wash out of any topical medications for at least 6 weeks.
Part 2: Care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
Healthy Participants: Post-Treatment- Part 2 Only
Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|---|
|
Part 2 intervention (7 months)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
1 subject in Group 2 withdrew consent after Part 1 Intervention
Baseline characteristics by cohort
| Measure |
Healthy Subjects: First Pre-Treatment Only(Part 1), Then Post-Treatment Only(Part 2) After Washout
n=12 Participants
Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care.
Part 2: Care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
Healthy Participants: Part 2 Only
n=3 Participants
Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive treatment using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=6009 Participants
|
3 Participants
n=42 Participants
|
15 Participants
n=77 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=6009 Participants
|
3 Participants
n=42 Participants
|
15 Participants
n=77 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=6009 Participants • 1 subject in Group 2 withdrew consent after Part 1 Intervention
|
2 Participants
n=42 Participants • 1 subject in Group 2 withdrew consent after Part 1 Intervention
|
3 Participants
n=77 Participants • 1 subject in Group 2 withdrew consent after Part 1 Intervention
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=6009 Participants • 1 subject in Group 2 withdrew consent after Part 1 Intervention
|
1 Participants
n=42 Participants • 1 subject in Group 2 withdrew consent after Part 1 Intervention
|
12 Participants
n=77 Participants • 1 subject in Group 2 withdrew consent after Part 1 Intervention
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6009 Participants • 1 subject in Group 2 withdrew consent after Part 1 Intervention
|
0 Participants
n=42 Participants • 1 subject in Group 2 withdrew consent after Part 1 Intervention
|
0 Participants
n=77 Participants • 1 subject in Group 2 withdrew consent after Part 1 Intervention
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6009 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
10 Participants
n=77 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=6009 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=77 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=6009 Participants
|
3 participants
n=42 Participants
|
15 participants
n=77 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 Month and 3 MonthsPopulation: Subjects who completed Part 1 intervention are only analyzed and reported here.
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of front face Count- the number of individual features detected in the region of interest.
Outcome measures
| Measure |
Group 2- Post-Treatment Only
n=10 Participants
Part 2: Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|
|
Change in Spots - Front of Face (Part 1)
Baseline
|
53.60 spots
Standard Deviation 14.01
|
|
Change in Spots - Front of Face (Part 1)
1 Month
|
58.47 spots
Standard Deviation 13.73
|
|
Change in Spots - Front of Face (Part 1)
3 Months
|
56.44 spots
Standard Deviation 15.14
|
PRIMARY outcome
Timeframe: Baseline, 1 Month and 3 MonthsPopulation: Data from 6 subjects in Part 1 who continued to Part 2 after washout and 2 new subjects who were added to Part 2 portion of this study were analyzed and reported in the data table below. 1 subject from Part 2, withdrew consent after 1st treatment and didn't return for 2nd treatment visit. So this subject's data wasn't included in the analysis.
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of front face Count- the number of individual features detected in the region of interest.
Outcome measures
| Measure |
Group 2- Post-Treatment Only
n=8 Participants
Part 2: Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|
|
Change in Spots - Front of Face (Part 2)
Baseline
|
56.57 spots
Standard Deviation 15.68
|
|
Change in Spots - Front of Face (Part 2)
1 Month
|
56.45 spots
Standard Deviation 18.40
|
|
Change in Spots - Front of Face (Part 2)
3 Months
|
49.93 spots
Standard Deviation 21.38
|
PRIMARY outcome
Timeframe: Baseline, 1 Month and 3 MonthsPopulation: Subjects who completed Part 1 intervention are only analyzed and reported here.
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of left side of face Count= the number if individual features detected in the region of interest.
Outcome measures
| Measure |
Group 2- Post-Treatment Only
n=10 Participants
Part 2: Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|
|
Change in Spots- Left Side of Face (Part 1)
Baseline
|
50.90 spots
Standard Deviation 13.22
|
|
Change in Spots- Left Side of Face (Part 1)
1 Month
|
49.37 spots
Standard Deviation 14.37
|
|
Change in Spots- Left Side of Face (Part 1)
3 Months
|
45.88 spots
Standard Deviation 11.26
|
PRIMARY outcome
Timeframe: Baseline, 1 Month and 3 MonthsPopulation: Data from 6 subjects in Part 1 who continued to Part 2 after washout and 2 new subjects who were added to Part 2 portion of this study were analyzed and reported in the data table below. 1 subject from Part 2, withdrew consent after 1st treatment and didn't return for 2nd treatment visit. So this subject's data wasn't included in the analysis.
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of left side of face Count= the number if individual features detected in the region of interest.
Outcome measures
| Measure |
Group 2- Post-Treatment Only
n=8 Participants
Part 2: Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|
|
Change in Spots- Left Side of Face (Part 2)
Baseline
|
48.01 spots
Standard Deviation 17.18
|
|
Change in Spots- Left Side of Face (Part 2)
1 Month
|
43.78 spots
Standard Deviation 13.07
|
|
Change in Spots- Left Side of Face (Part 2)
3 Months
|
41.94 spots
Standard Deviation 17.03
|
PRIMARY outcome
Timeframe: Baseline, 1 Month and 3 MonthsPopulation: Subjects who completed Part 1 intervention are only analyzed and reported here.
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of right side of face Count= the number if individual features detected in the region of interest.
Outcome measures
| Measure |
Group 2- Post-Treatment Only
n=10 Participants
Part 2: Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|
|
Change in Spots- Right Side of Face (Part 1)
Baseline
|
46.49 spots
Standard Deviation 14.05
|
|
Change in Spots- Right Side of Face (Part 1)
1 Month
|
46.47 spots
Standard Deviation 15.27
|
|
Change in Spots- Right Side of Face (Part 1)
3 Months
|
46.15 spots
Standard Deviation 13.68
|
PRIMARY outcome
Timeframe: Baseline, 1 Month and 3 MonthsPopulation: Data from 6 subjects in Part 1 who continued to Part 2 after washout and 2 new subjects who were added to Part 2 portion of this study were analyzed and reported in the data table below. 1 subject from Part 2, withdrew consent after 1st treatment and didn't return for 2nd treatment visit. So this subject's data wasn't included in the analysis.
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of right side of face Count= the number if individual features detected in the region of interest.
Outcome measures
| Measure |
Group 2- Post-Treatment Only
n=8 Participants
Part 2: Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|
|
Change in Spots- Right Side of Face (Part 2)
3 Months
|
43.68 spots
Standard Deviation 13.83
|
|
Change in Spots- Right Side of Face (Part 2)
Baseline
|
41.65 spots
Standard Deviation 15.69
|
|
Change in Spots- Right Side of Face (Part 2)
1 Month
|
44.87 spots
Standard Deviation 16.62
|
PRIMARY outcome
Timeframe: Baseline, 1 Month and 3 MonthsPopulation: Subjects who completed Part 1 intervention are only analyzed and reported here.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of front side of face Count= the number if individual features detected in the region of interest.
Outcome measures
| Measure |
Group 2- Post-Treatment Only
n=10 Participants
Part 2: Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|
|
Change in UV Spots- Front of Face (Part 1)
Baseline
|
4.55 UV Spots
Standard Deviation 6.36
|
|
Change in UV Spots- Front of Face (Part 1)
1 Month
|
4.26 UV Spots
Standard Deviation 5.94
|
|
Change in UV Spots- Front of Face (Part 1)
3 Months
|
3.67 UV Spots
Standard Deviation 6.92
|
PRIMARY outcome
Timeframe: Baseline, 1 Month and 3 MonthsPopulation: Data from 6 subjects in Part 1 who continued to Part 2 after washout and 2 new subjects who were added to Part 2 portion of this study were analyzed and reported in the data table below. 1 subject from Part 2, withdrew consent after 1st treatment and didn't return for 2nd treatment visit. So this subject's data wasn't included in the analysis.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of front side of face Count= the number if individual features detected in the region of interest.
Outcome measures
| Measure |
Group 2- Post-Treatment Only
n=8 Participants
Part 2: Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|
|
Change in UV Spots- Front of Face (Part 2)
Baseline
|
6.01 UV Spots
Standard Deviation 6.28
|
|
Change in UV Spots- Front of Face (Part 2)
1 Month
|
7.92 UV Spots
Standard Deviation 9.86
|
|
Change in UV Spots- Front of Face (Part 2)
3 Months
|
4.70 UV Spots
Standard Deviation 5.91
|
PRIMARY outcome
Timeframe: Baseline, 1 Month and 3 MonthsPopulation: Subjects who completed Part 1 intervention are only analyzed and reported here.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of left side of the face Count= the number if individual features detected in the region of interest.
Outcome measures
| Measure |
Group 2- Post-Treatment Only
n=10 Participants
Part 2: Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|
|
Change in UV Spots- Left of Face (Part 1)
1 Month
|
4.69 UV Spots
Standard Deviation 5.17
|
|
Change in UV Spots- Left of Face (Part 1)
3 Months
|
5.69 UV Spots
Standard Deviation 10.54
|
|
Change in UV Spots- Left of Face (Part 1)
Baseline
|
5.87 UV Spots
Standard Deviation 5.90
|
PRIMARY outcome
Timeframe: Baseline, 1 Month and 3 MonthsPopulation: Data from 6 subjects in Part 1 who continued to Part 2 after washout and 2 new subjects who were added to Part 2 portion of this study were analyzed and reported in the data table below. 1 subject from Part 2, withdrew consent after 1st treatment and didn't return for 2nd treatment visit. So this subject's data wasn't included in the analysis.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of left side of the face Count= the number if individual features detected in the region of interest.
Outcome measures
| Measure |
Group 2- Post-Treatment Only
n=8 Participants
Part 2: Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|
|
Change in UV Spots- Left of Face (Part 2)
Baseline
|
4.60 UV Spots
Standard Deviation 8.01
|
|
Change in UV Spots- Left of Face (Part 2)
1 Month
|
2.50 UV Spots
Standard Deviation 3.71
|
|
Change in UV Spots- Left of Face (Part 2)
3 Months
|
3.54 UV Spots
Standard Deviation 3.30
|
PRIMARY outcome
Timeframe: Baseline, 1 Month and 3 MonthsPopulation: Subjects who completed Part 1 intervention are only analyzed and reported here.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of right side of face Count= the number if individual features detected in the region of interest.
Outcome measures
| Measure |
Group 2- Post-Treatment Only
n=10 Participants
Part 2: Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|
|
Change in UV Spots- Right Side if Face (Part 1)
Baseline
|
6.35 UV Spots
Standard Deviation 7.58
|
|
Change in UV Spots- Right Side if Face (Part 1)
1 Month
|
4.25 UV Spots
Standard Deviation 4.34
|
|
Change in UV Spots- Right Side if Face (Part 1)
3 Months
|
4.51 UV Spots
Standard Deviation 6.32
|
PRIMARY outcome
Timeframe: Baseline, 1 Month and 3 MonthsPopulation: Data from 6 subjects in Part 1 who continued to Part 2 after washout and 2 new subjects who were added to Part 2 portion of this study were analyzed and reported in the data table below. 1 subject from Part 2, withdrew consent after 1st treatment and didn't return for 2nd treatment visit. So this subject's data wasn't included in the analysis.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of right side of face Count= the number if individual features detected in the region of interest.
Outcome measures
| Measure |
Group 2- Post-Treatment Only
n=8 Participants
Part 2: Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|
|
Change in UV Spots- Right Side if Face (Part 2)
Baseline
|
2.71 UV Spots
Standard Deviation 3.43
|
|
Change in UV Spots- Right Side if Face (Part 2)
1 Month
|
3.33 UV Spots
Standard Deviation 3.32
|
|
Change in UV Spots- Right Side if Face (Part 2)
3 Months
|
3.50 UV Spots
Standard Deviation 3.27
|
PRIMARY outcome
Timeframe: Baseline, 1 Month and 3 MonthsPopulation: Subjects who completed Part 1 intervention are only analyzed and reported here.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of front of face Count= the number if individual features detected in the region of interest.
Outcome measures
| Measure |
Group 2- Post-Treatment Only
n=10 Participants
Part 2: Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|
|
Change in Brown Spots- Front of Face (Part 1)
Baseline
|
35.14 Brown Spots
Standard Deviation 10.73
|
|
Change in Brown Spots- Front of Face (Part 1)
1 Month
|
34.31 Brown Spots
Standard Deviation 12.29
|
|
Change in Brown Spots- Front of Face (Part 1)
3 Months
|
32.73 Brown Spots
Standard Deviation 20.67
|
PRIMARY outcome
Timeframe: Baseline, 1 Month and 3 MonthsPopulation: Data from 6 subjects in Part 1 who continued to Part 2 after washout and 2 new subjects who were added to Part 2 portion of this study were analyzed and reported in the data table below. 1 subject from Part 2, withdrew consent after 1st treatment and didn't return for 2nd treatment visit. So this subject's data wasn't included in the analysis.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of front of face Count= the number if individual features detected in the region of interest.
Outcome measures
| Measure |
Group 2- Post-Treatment Only
n=8 Participants
Part 2: Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|
|
Change in Brown Spots- Front of Face (Part 2)
Baseline
|
27.67 Brown Spots
Standard Deviation 6.31
|
|
Change in Brown Spots- Front of Face (Part 2)
1 Month
|
39.74 Brown Spots
Standard Deviation 14.29
|
|
Change in Brown Spots- Front of Face (Part 2)
3 Months
|
33.36 Brown Spots
Standard Deviation 14.79
|
PRIMARY outcome
Timeframe: Baseline, 1 Month and 3 MonthsPopulation: Subjects who completed Part 1 intervention are only analyzed and reported here.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of left side of face Count= the number if individual features detected in the region of interest.
Outcome measures
| Measure |
Group 2- Post-Treatment Only
n=10 Participants
Part 2: Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|
|
Change in Brown Spots- Left of Face (Part 1)
Baseline
|
47.87 Brown spots
Standard Deviation 14.20
|
|
Change in Brown Spots- Left of Face (Part 1)
1 Month
|
47.97 Brown spots
Standard Deviation 20.96
|
|
Change in Brown Spots- Left of Face (Part 1)
3 Months
|
45.81 Brown spots
Standard Deviation 13.97
|
PRIMARY outcome
Timeframe: Baseline, 1 Month and 3 MonthsPopulation: Data from 6 subjects in Part 1 who continued to Part 2 after washout and 2 new subjects who were added to Part 2 portion of this study were analyzed and reported in the data table below. 1 subject from Part 2, withdrew consent after 1st treatment and didn't return for 2nd treatment visit. So this subject's data wasn't included in the analysis.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of left side of face Count= the number if individual features detected in the region of interest.
Outcome measures
| Measure |
Group 2- Post-Treatment Only
n=8 Participants
Part 2: Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|
|
Change in Brown Spots- Left of Face (Part 2)
Baseline
|
39.03 Brown spots
Standard Deviation 18.95
|
|
Change in Brown Spots- Left of Face (Part 2)
1 Month
|
45.10 Brown spots
Standard Deviation 14.16
|
|
Change in Brown Spots- Left of Face (Part 2)
3 Months
|
39.49 Brown spots
Standard Deviation 14.55
|
PRIMARY outcome
Timeframe: Baseline, 1 Month and 3 MonthsPopulation: Subjects who completed Part 1 intervention are only analyzed and reported here.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of right side of face Count= the number if individual features detected in the region of interest.
Outcome measures
| Measure |
Group 2- Post-Treatment Only
n=10 Participants
Part 2: Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|
|
Change in Brown Spots- Right Side of Face (Part 1)
Baseline
|
41.73 Brown Spots
Standard Deviation 15.87
|
|
Change in Brown Spots- Right Side of Face (Part 1)
1 Month
|
47.59 Brown Spots
Standard Deviation 13.77
|
|
Change in Brown Spots- Right Side of Face (Part 1)
3 Months
|
41.42 Brown Spots
Standard Deviation 15.08
|
PRIMARY outcome
Timeframe: Baseline, 1 Month and 3 MonthsPopulation: Data from 6 subjects in Part 1 who continued to Part 2 after washout and 2 new subjects who were added to Part 2 portion of this study were analyzed and reported in the data table below. 1 subject from Part 2, withdrew consent after 1st treatment and didn't return for 2nd treatment visit. So this subject's data wasn't included in the analysis.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of right side of face Count= the number if individual features detected in the region of interest.
Outcome measures
| Measure |
Group 2- Post-Treatment Only
n=8 Participants
Part 2: Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days.
MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.
|
|---|---|
|
Change in Brown Spots- Right Side of Face (Part 2)
Baseline
|
33.83 Brown Spots
Standard Deviation 11.95
|
|
Change in Brown Spots- Right Side of Face (Part 2)
3 Months
|
40.99 Brown Spots
Standard Deviation 7.26
|
|
Change in Brown Spots- Right Side of Face (Part 2)
1 Month
|
34.27 Brown Spots
Standard Deviation 19.96
|
Adverse Events
Part 1 Intervention
Part 2 Intervention (after Part 1)
Part 2 Intervention only
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place