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The primary objective of this study is to assess the efficacy of 1927nm non-ablative fractionated laser therapy to treat hyperpigmentation in patients ages 18-75 with Fitzpatrick Skin Phototypes V and VI and explore an effective, adjunctive pre- and post-procedural regimen to prevent iatrogenic dyspigmentation or scarring in this population.
This single-center clinical trial is being conducted over the course of 7 months, including one Initial Screening Visit (-42 to -28 Days) and three treatments (Day 0, Day 30, Day 60) followed by 1-month and 3-month follow-up visits (Day 90 and Day 120). The primary objective of this study is to assess the efficacy of 1927nm non-ablative fractionated laser therapy to treat hyperpigmentation in patients ages 18-75 with Fitzpatrick Skin Phototypes V and VI and explore an effective, adjunctive pre- and post-procedural regimen to prevent iatrogenic dyspigmentation or scarring in this population.
The Investigators will explore this question with a non-blinded, pilot study at a single center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Participants- Pre-Ttreatment Only | Other | Subjects who are interested in treatment for hyperpigmentation will be enrolled for this study. Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. |
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| Healthy Participants- Post-Treatment Only | Other | Subjects who are interested in treatment for hyperpigmentation will be enrolled for this study. Subjects will wash out of any topical medications and will receive treatment. Post-treatment care will include use of temovate for 4 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOXI | Device | Patients will receive treatment using f1927 devices and will be treated over the affected areas, once each month for a total of three months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Spots - Front of Face (Part 1) | 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. | Baseline, 1 Month and 3 Months |
| Change in Spots - Front of Face (Part 2) | 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. | Baseline, 1 Month and 3 Months |
| Change in Spots- Left Side of Face (Part 1) | 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. | Baseline, 1 Month and 3 Months |
| Change in Spots- Left Side of Face (Part 2) | 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. | Baseline, 1 Month and 3 Months |
| Change in Spots- Right Side of Face (Part 1) | 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. | Baseline, 1 Month and 3 Months |
| Change in Spots- Right Side of Face (Part 2) | 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. |
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Inclusion Criteria:
Healthy male, female, and non-binary adults between 18 and 75 years of age
Fitzpatrick Skin Phototype V and VI
Individuals deemed by the Investigator to have clinically significant hyperpigmentation on their face and desire treatment and correction of this condition
Individuals willing to withhold aesthetic therapies (excluding those explicitly prescribed by the Investigator as pre-treatment) for the duration of the study
Women of childbearing potential who agree to take a urine pregnancy test at the Screening visit or when deemed by Investigator. Women of childbearing potential must have a negative urine pregnancy test and must not be lactating at Screening. Women must be willing and able to use an acceptable method of birth control (see below) during the study. Women will not be considered of childbearing potential if one or more of the following is documented:
Individuals of childbearing potential who use an acceptable method of contraception for the duration of the study. Acceptable modes of birth control include the following:
Individuals who can read, speak, write, and understand English and who are willing to provide written informed consent.
Individuals willing to sign a photography release.
Individuals willing and able to cooperate with all study requirements for the duration of the study, including prescribed pre- and post-procedure topical regimens
Exclusion Criteria:
Ages < 18 or > 75 years old
Fitzpatrick Skin Phototypes I-IV
Known history of allergies or irritant contact dermatitis in response to general skin care products, including Hydroquinone and Retinol
Known allergies or irritant contact dermatitis in response to common ingredients of physical sunscreen, including but not limited to Zinc Oxide
Known allergies or irritant contact dermatitis to topical anesthetics, including Benzocaine and Tetracaine.
Active local or systemic disorders that may affect wound healing or integrity of the integumentary system
History of active or inactive systemic granulomatous disease, (e.g., Sarcoidosis, Tuberculosis, Granulomatosis with Polyangiitis, etc.), or connective tissue disorders (e.g., Systemic Lupus Erythematosus, Dermatomyositis, Scleroderma, etc.)
Recent history of surgery or significant trauma to the area(s) to be treated
Significant scarring (excluding acne scars) in the area(s) to be treated
Current or history of hypertrophic scarring or keloid scars
Severe or cystic and clinically active acne on the area(s) to be treated
Tattoos in the area(s) to be treated
Individuals who currently have cancerous or pre-cancerous lesions in the area(s) to be treated and/or have a history of skin cancer
Individuals with skin pathology and/or pre-existing dermatologic condition in the treatment area (i.e., psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, hyper or hypo-skin pigmentation conditions such as post inflammatory hyperpigmentation) that the Investigator deems inappropriate for participation or could interfere with outcomes of the study.
History of chronic drug or alcohol use.
Microdermabrasion or glycolic acid treatment to the treatment area(s) within 4 weeks of study participation or who plan on having this treatment during the study.
History of the following cosmetic treatments in the area(s) to be treated:
Individuals undergoing concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study devices:
• Antiplatelet agents/anticoagulants (Coumadin, Heparin, Plavix, chronic NSAID use), and/or
Psychiatric drugs that, in the Investigator's opinion, would impair the subject from understanding protocol requirements or understanding and signing consent.
Individuals who are pregnant or nursing or those planning on becoming pregnant during the study according to self-report.
Immunocompromised individuals or those currently using immunosuppressive medications and/or radiation.
Individuals with uncontrolled disease such as asthma, diabetes, hyperthyroidism, medically significant hypertension, or hypothyroidism. Those with multiple health conditions may still be excluded from participation even if conditions are controlled.
Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical procedures planned during the study.
Individuals who, in the Investigator's opinion, have a history of poor cooperation, unreliability or noncompliance with medical treatment.
Individuals who are unable to understand instructions or give informed consent
Individuals who have physical or psychological conditions which, in the opinion of the Investigator, makes them unable to complete the study per protocol (e.g., not likely to avoid other cosmetic treatments to area; not likely to stay in study for entire duration due to other commitments; or those with concomitant conditions that may develop symptoms that might confuse or confound study treatments or assessments).
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Kenkel, MD | UT Southwestern- Department of Plastic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center- Dept of Plastic Surgery | Dallas | Texas | 75390 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 Intervention (7 months) |
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| Washout Period (1 month) |
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| Part 2 intervention (7 months) |
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12 subjects started Part 1 (Pre-Treatment Group), and after washout, in Part 2 portion of this study, 3 additional subjects were enrolled as represented in the table below.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Spots - Front of Face (Part 1) | 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. | Subjects who completed Part 1 intervention are only analyzed and reported here. | Posted | Mean | Standard Deviation | spots | Baseline, 1 Month and 3 Months |
|
3 Months
For 1 subject in Part 2, AEs were collected until they withdrew consent [i.e., after 1st treatment (2nd visit)]
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1 Intervention | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lead Coordinator | UT Southwestern | 214-645-8907 | jennifer.barillas@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2023 | Jun 9, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Baseline, 1 Month and 3 Months |
| Change in UV Spots- Front of Face (Part 1) | 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. | Baseline, 1 Month and 3 Months |
| Change in UV Spots- Front of Face (Part 2) | 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. | Baseline, 1 Month and 3 Months |
| Change in UV Spots- Left of Face (Part 1) | 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. | Baseline, 1 Month and 3 Months |
| Change in UV Spots- Left of Face (Part 2) | 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. | Baseline, 1 Month and 3 Months |
| Change in UV Spots- Right Side if Face (Part 1) | 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. | Baseline, 1 Month and 3 Months |
| Change in UV Spots- Right Side if Face (Part 2) | 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. | Baseline, 1 Month and 3 Months |
| Change in Brown Spots- Front of Face (Part 1) | 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. | Baseline, 1 Month and 3 Months |
| Change in Brown Spots- Front of Face (Part 2) | 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. | Baseline, 1 Month and 3 Months |
| Change in Brown Spots- Left of Face (Part 1) | 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. | Baseline, 1 Month and 3 Months |
| Change in Brown Spots- Left of Face (Part 2) | 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. | Baseline, 1 Month and 3 Months |
| Change in Brown Spots- Right Side of Face (Part 1) | 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. | Baseline, 1 Month and 3 Months |
| Change in Brown Spots- Right Side of Face (Part 2) | 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. | Baseline, 1 Month and 3 Months |
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| NOT COMPLETED |
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| BG001 | Healthy Participants: Part 2 Only | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 1 subject in Group 2 withdrew consent after Part 1 Intervention | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Change in Spots - Front of Face (Part 2) | 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. | 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. | Posted | Mean | Standard Deviation | spots | Baseline, 1 Month and 3 Months |
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| Primary | Change in Spots- Left Side of Face (Part 1) | 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. | Subjects who completed Part 1 intervention are only analyzed and reported here. | Posted | Mean | Standard Deviation | spots | Baseline, 1 Month and 3 Months |
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| Primary | Change in Spots- Left Side of Face (Part 2) | 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. | 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. | Posted | Mean | Standard Deviation | spots | Baseline, 1 Month and 3 Months |
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| Primary | Change in Spots- Right Side of Face (Part 1) | 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. | Subjects who completed Part 1 intervention are only analyzed and reported here. | Posted | Mean | Standard Deviation | spots | Baseline, 1 Month and 3 Months |
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| Primary | Change in Spots- Right Side of Face (Part 2) | 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. | 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. | Posted | Mean | Standard Deviation | spots | Baseline, 1 Month and 3 Months |
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| Primary | Change in UV Spots- Front of Face (Part 1) | 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. | Subjects who completed Part 1 intervention are only analyzed and reported here. | Posted | Mean | Standard Deviation | UV Spots | Baseline, 1 Month and 3 Months |
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| Primary | Change in UV Spots- Front of Face (Part 2) | 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. | 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. | Posted | Mean | Standard Deviation | UV Spots | Baseline, 1 Month and 3 Months |
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| Primary | Change in UV Spots- Left of Face (Part 1) | 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. | Subjects who completed Part 1 intervention are only analyzed and reported here. | Posted | Mean | Standard Deviation | UV Spots | Baseline, 1 Month and 3 Months |
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| Primary | Change in UV Spots- Left of Face (Part 2) | 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. | 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. | Posted | Mean | Standard Deviation | UV Spots | Baseline, 1 Month and 3 Months |
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| Primary | Change in UV Spots- Right Side if Face (Part 1) | 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. | Subjects who completed Part 1 intervention are only analyzed and reported here. | Posted | Mean | Standard Deviation | UV Spots | Baseline, 1 Month and 3 Months |
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| Primary | Change in UV Spots- Right Side if Face (Part 2) | 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. | 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. | Posted | Mean | Standard Deviation | UV Spots | Baseline, 1 Month and 3 Months |
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| Primary | Change in Brown Spots- Front of Face (Part 1) | 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. | Subjects who completed Part 1 intervention are only analyzed and reported here. | Posted | Mean | Standard Deviation | Brown Spots | Baseline, 1 Month and 3 Months |
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| Primary | Change in Brown Spots- Front of Face (Part 2) | 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. | 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. | Posted | Mean | Standard Deviation | Brown Spots | Baseline, 1 Month and 3 Months |
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| Primary | Change in Brown Spots- Left of Face (Part 1) | 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. | Subjects who completed Part 1 intervention are only analyzed and reported here. | Posted | Mean | Standard Deviation | Brown spots | Baseline, 1 Month and 3 Months |
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| Primary | Change in Brown Spots- Left of Face (Part 2) | 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. | 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. | Posted | Mean | Standard Deviation | Brown spots | Baseline, 1 Month and 3 Months |
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| Primary | Change in Brown Spots- Right Side of Face (Part 1) | 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. | Subjects who completed Part 1 intervention are only analyzed and reported here. | Posted | Mean | Standard Deviation | Brown Spots | Baseline, 1 Month and 3 Months |
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| Primary | Change in Brown Spots- Right Side of Face (Part 2) | 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. | 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. | Posted | Mean | Standard Deviation | Brown Spots | Baseline, 1 Month and 3 Months |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Part 2 Intervention (after Part 1) | Subjects will wash out of any topical medications and will receive 3 treatments. 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. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Part 2 Intervention only | 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. | 0 | 3 | 0 | 3 | 0 | 3 |
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