Trial Outcomes & Findings for Fractionated 1927nm Laser for Hyperpigmentation in Fitzpatrick Skin Phototypes V and VI (NCT NCT05493280)

NCT ID: NCT05493280

Last Updated: 2025-11-14

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: Baseline, 1 Month and 3 Months
• Results posted on: 2025-11-14

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	6	2
Part 2 intervention (7 months) NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

1 subject in Group 2 withdrew consent

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=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=10 Participants	3 Participants n=10 Participants	15 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Sex: Female, Male Female	12 Participants n=10 Participants	3 Participants n=10 Participants	15 Participants n=20 Participants
Sex: Female, Male Male	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=10 Participants • 1 subject in Group 2 withdrew consent	2 Participants n=10 Participants • 1 subject in Group 2 withdrew consent	3 Participants n=20 Participants • 1 subject in Group 2 withdrew consent
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=10 Participants • 1 subject in Group 2 withdrew consent	1 Participants n=10 Participants • 1 subject in Group 2 withdrew consent	12 Participants n=20 Participants • 1 subject in Group 2 withdrew consent
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants • 1 subject in Group 2 withdrew consent	0 Participants n=10 Participants • 1 subject in Group 2 withdrew consent	0 Participants n=20 Participants • 1 subject in Group 2 withdrew consent
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	10 Participants n=10 Participants	0 Participants n=10 Participants	10 Participants n=20 Participants
Race (NIH/OMB) White	2 Participants n=10 Participants	2 Participants n=10 Participants	4 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Region of Enrollment United States	12 participants n=10 Participants	3 participants n=10 Participants	15 participants n=20 Participants

PRIMARY outcome

Timeframe: Baseline, 1 Month and 3 Months

Population: 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	Healthy subjects-Part 1:- Pre-Treatment Only n=10 Participants Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. 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 Months

Population: 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	Healthy subjects-Part 1:- Pre-Treatment Only n=8 Participants Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. 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 Months

Population: 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	Healthy subjects-Part 1:- Pre-Treatment Only n=10 Participants Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. 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 Months

Population: 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	Healthy subjects-Part 1:- Pre-Treatment Only n=8 Participants Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. 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 Months

Population: 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	Healthy subjects-Part 1:- Pre-Treatment Only n=10 Participants Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. 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 Months

Population: 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	Healthy subjects-Part 1:- Pre-Treatment Only n=8 Participants Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. 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) 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
Change in Spots- Right Side of Face (Part 2) 3 Months	43.68 spots Standard Deviation 13.83

PRIMARY outcome

Timeframe: Baseline, 1 Month and 3 Months

Population: 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	Healthy subjects-Part 1:- Pre-Treatment Only n=10 Participants Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. 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 Months

Population: 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	Healthy subjects-Part 1:- Pre-Treatment Only n=8 Participants Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. 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 Months

Population: 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	Healthy subjects-Part 1:- Pre-Treatment Only n=10 Participants Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. 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) Baseline	5.87 UV Spots Standard Deviation 5.90
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

PRIMARY outcome

Timeframe: Baseline, 1 Month and 3 Months

Population: 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	Healthy subjects-Part 1:- Pre-Treatment Only n=8 Participants Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. 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 Months

Population: 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	Healthy subjects-Part 1:- Pre-Treatment Only n=10 Participants Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. 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 Months

Population: 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	Healthy subjects-Part 1:- Pre-Treatment Only n=8 Participants Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. 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 Months

Population: 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	Healthy subjects-Part 1:- Pre-Treatment Only n=10 Participants Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. 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 Months

Population: 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	Healthy subjects-Part 1:- Pre-Treatment Only n=8 Participants Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. 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 Months

Population: 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	Healthy subjects-Part 1:- Pre-Treatment Only n=10 Participants Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. 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 Months

Population: 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	Healthy subjects-Part 1:- Pre-Treatment Only n=8 Participants Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. 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 Months

Population: 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	Healthy subjects-Part 1:- Pre-Treatment Only n=10 Participants Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. 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 Months

Population: 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	Healthy subjects-Part 1:- Pre-Treatment Only n=8 Participants Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. 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) 1 Month	34.27 Brown Spots Standard Deviation 19.96
Change in Brown Spots- Right Side of Face (Part 2) 3 Months	40.99 Brown Spots Standard Deviation 7.26

Adverse Events

Part 1 Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2 Intervention (after Part 1)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2 Intervention only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lead Coordinator

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