Trial Outcomes & Findings for Fractionated 1927nm Laser for Diffuse Pigmentation and Actinic Changes. (NCT NCT05226104)

Last Updated: 2023-08-21

Results Overview

Numeric analysis of dyspigmentation (spots) will be analyzed using VISIA System. The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Baseline, Month 1 and Month 3

Results posted on

2023-08-21

Participant Flow

27 patients underwent two treatments with non-ablative, f1927nm laser.

Participant milestones

Participant milestones
Measure	Non-ablative f1927nm Laser Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study. MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
Overall Study STARTED	27
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fractionated 1927nm Laser for Diffuse Pigmentation and Actinic Changes.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-ablative f1927nm Laser n=27 Participants Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study. MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	27 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	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Fitzpatrick Skin Prototype Type 1	4 Participants n=5 Participants
Fitzpatrick Skin Prototype Type 2	7 Participants n=5 Participants
Fitzpatrick Skin Prototype Type 3	6 Participants n=5 Participants
Fitzpatrick Skin Prototype Type 4	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 1 and Month 3

Population: The left and right side of each participant's face was analyzed separately resulting in an n of 48.

Outcome measures

Outcome measures
Measure	Location: Left n=24 Location Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study. MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.	Location: Right n=24 Location Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study. MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
Change in Dyspigmentation Spots Baseline	48.3 Dyspigmentation Spots Standard Deviation 12.1	46 Dyspigmentation Spots Standard Deviation 11.8
Change in Dyspigmentation Spots Month 1	42.2 Dyspigmentation Spots Standard Deviation 13.8	42.5 Dyspigmentation Spots Standard Deviation 10.9
Change in Dyspigmentation Spots Month 3	46.1 Dyspigmentation Spots Standard Deviation 13.1	42.9 Dyspigmentation Spots Standard Deviation 10.8

PRIMARY outcome

Timeframe: Baseline, Month 1 and Month 3

Population: The left and right side of each participant's face was analyzed separately resulting in an n of 48.

Numeric analysis of lesions resulting from photodamage will be analyzed using VISIA System. The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.

Outcome measures

Outcome measures
Measure	Location: Left n=24 Location Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study. MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.	Location: Right n=24 Location Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study. MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
Change in UV Spots Baseline	29.4 UV Spots Standard Deviation 9.9	25.4 UV Spots Standard Deviation 9.3
Change in UV Spots Month 1	22.4 UV Spots Standard Deviation 10.1	21.6 UV Spots Standard Deviation 9.7
Change in UV Spots Month 3	25.8 UV Spots Standard Deviation 9.6	24.3 UV Spots Standard Deviation 10.8

PRIMARY outcome

Timeframe: Baseline, Month 1 and Month 3

Population: The left and right side of each participant's face was analyzed separately resulting in an n of 48.

Numeric analysis of lentigines and melasma will be analyzed using the VISIA system. The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.

Outcome measures

Outcome measures
Measure	Location: Left n=24 Location Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study. MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.	Location: Right n=24 Location Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study. MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
Change in Brown Spots Month 1	56.3 Brown Spots Standard Deviation 8.8	57.1 Brown Spots Standard Deviation 8.8
Change in Brown Spots Month 3	59.1 Brown Spots Standard Deviation 10.1	58.6 Brown Spots Standard Deviation 9.1
Change in Brown Spots Baseline	62.5 Brown Spots Standard Deviation 9.1	60.3 Brown Spots Standard Deviation 10.8

PRIMARY outcome

Timeframe: Month 1 and Month 3

Clinician evaluators assessed the right side of each participants 1 and 3 month photographs to subjectively score clinical improvement. PGAS Score Description 0 Clear, except for possible residual discoloration, 100% improvement. 1. Almost clear, very significant clearance, 90% improvement; only minor evidence of hyperpigmentation remains. 2. Marked improvement, significant improvement, 75% improvement. Some disease evidence of hyperpigmentation remains. 3. Moderate improvement, intermediate between slight and marked improvement; 50% improvement in appearance of hyperpigmentation 4. Slight improvement, some improvement, 25% improvement; significant evidence of hyperpigmentation remains 5. No improvement; hyperpigmented condition unchanged 6. Worse; condition worse than at week 0

Outcome measures

Outcome measures
Measure	Location: Left n=24 Participants Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study. MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.	Location: Right Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study. MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
Physician's Global Assessment Scores (PGAS)- Right Face 1 Month	3.45 score on a scale Standard Deviation 1.23	—
Physician's Global Assessment Scores (PGAS)- Right Face 3 Month	3.60 score on a scale Standard Deviation 1.35	—

PRIMARY outcome

Timeframe: Month 1 and Month 3

Clinician evaluators assessed the left side of each participants 1 and 3 month photographs to subjectively score clinical improvement. PGAS Score Description 0 Clear, except for possible residual discoloration, 100% improvement. 1. Almost clear, very significant clearance, 90% improvement; only minor evidence of hyperpigmentation remains. 2. Marked improvement, significant improvement, 75% improvement. Some disease evidence of hyperpigmentation remains. 3. Moderate improvement, intermediate between slight and marked improvement; 50% improvement in appearance of hyperpigmentation 4. Slight improvement, some improvement, 25% improvement; significant evidence of hyperpigmentation remains 5. No improvement; hyperpigmented condition unchanged 6. Worse; condition worse than at week 0

Outcome measures

Outcome measures
Measure	Location: Left n=24 Participants Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study. MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.	Location: Right Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study. MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
Physician's Global Assessment Scores (PGAS)- Left Face Month 1	3.44 score on a scale Standard Deviation 1.15	—
Physician's Global Assessment Scores (PGAS)- Left Face Month 3	3.72 score on a scale Standard Deviation 1.32	—

PRIMARY outcome

Timeframe: Month 1 and Month 3

Clinician evaluators assessed 1 and 3 month photographs to subjectively score clinical overall improvement. PGAS Score Description 0 Clear, except for possible residual discoloration, 100% improvement. 1. Almost clear, very significant clearance, 90% improvement; only minor evidence of hyperpigmentation remains. 2. Marked improvement, significant improvement, 75% improvement. Some disease evidence of hyperpigmentation remains. 3. Moderate improvement, intermediate between slight and marked improvement; 50% improvement in appearance of hyperpigmentation 4. Slight improvement, some improvement, 25% improvement; significant evidence of hyperpigmentation remains 5. No improvement; hyperpigmented condition unchanged 6. Worse; condition worse than at week 0

Outcome measures

Outcome measures
Measure	Location: Left n=24 Participants Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study. MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.	Location: Right Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study. MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
Physician's Global Assessment Score (PGAS)- Overall Month 1	3.44 score on a scale Standard Deviation 1.14	—
Physician's Global Assessment Score (PGAS)- Overall Month 3	3.66 score on a scale Standard Deviation 1.28	—

Adverse Events

Non-ablative f1927nm Laser

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Non-ablative f1927nm Laser n=27 participants at risk Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study. MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
Musculoskeletal and connective tissue disorders sprained ankle	3.7% 1/27 • Number of events 1 • Data was collected within a 3 month period.

Additional Information

Research Coordinator

UT Southwestern

Phone: 214-645-8907

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place