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| Name | Class |
|---|---|
| Sciton | INDUSTRY |
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This is a single-site, non-randomized, non-controlled study at UT Southwestern Medical Center at Dallas in the Department of Plastic Surgery. The study is designed to follow up to 15 consenting subjects who may receive up to 2 BBL/MOXI/HALO treatments under an IRB approved protocol.
Subjects will receive 1-2 BBL/MOXI/HALO treatments. All 2nd treatments will be scheduled 4-8 weeks after the initial treatment to ensure the skin has enough time to recover. Overall assessments will be collected before the first treatment and at subsequent follow-up visits at 1 Month and 3 Months post final treatment. Identifiable full-face standard and close-up photography will be obtained and used to evaluate any changes. Subjects will also have photos obtained with the VISIA-CR Imaging System (Canfield Scientific, Parsippany, NJ). Quantitative analysis will be completed on the VISIA imaging system and be used to compare the effects of the treatments. Any improvements will be evaluated to pre-treatment assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Treatment Arm | Active Comparator | Subjects will receive a single treatment of BBL/MOXI/HALO |
|
| Double Treatment Arm | Active Comparator | Subjects will receive double treatment of BBL/MOXI/HALO 4-6 weeks apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sciton Joule System | Device | Sciton Joule System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brown Spots at 1 Month From Baseline (Single Treatment Group) | Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Baseline, 1 Month |
| Change in Brown Spots at 3 Months From Baseline (Single Treatment Group) | Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Baseline, 3 Months |
| Change in Brown Spots at 1 Month From Baseline (Double Treatment Group) | Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Baseline, 1 Month |
| Change in Brown Spots at 3 Months From Baseline (Double Treatment Group) | Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Baseline, 3 Months |
| Change in Pores at 1 Month From Baseline (Single Treatment Group) | Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Baseline, 1 Month |
| Change in Pores at 3 Months From Baseline (Single Treatment Group) | Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. |
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Inclusion Criteria:
Healthy male and female adults between 20-75 years of age
Fitzpatrick skin type 1-4
Individual deemed by the Investigator to benefit from skin resurfacing treatment(s)
Individuals willing to withhold aesthetic therapies that may potentially impact results to the treatment areas for the duration of the study
Women of childbearing potential:
5.1. will be asked to agree to a pregnancy test before their screening visit in clinic 5.2. must use an acceptable method of birth control
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 with the understanding that their photos may be used during presentations at national conferences and/or published in journals
Individuals willing and able to cooperate with all study requirements for the duration of the study.
Exclusion Criteria:
Fitzpatrick skin type V-VI
Known allergies to general skin care products
Sensitivity to topical local anesthetic
Current or recent history of skin diseases:
• Systemic granulomatous disease, either active or inactive, (e.g., Sarcoid, Wegener's, TB, etc) or connective tissue diseases (e.g., lupus, dermatomyositis, etc.)
Significant scars in the treatment area:
Tattoos in the area to be treated
Observable suntan, nevi, excessive hair, etc., or other dermal conditions that might influence study results on the face in the opinion of the Investigator
Individuals who currently have cancerous or pre-cancerous lesions in the area to be treated
Individuals with skin pathology and/or pre-existing dermatologic condition that the Investigator deems inappropriate for participation or could interfere with outcomes of the study, such as: psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, etc.
History of chronic drug or alcohol use
Recent aesthetic treatments:
Use of the following prescription medications:
Individuals who are pregnant or planning to become pregnant during the course of the study
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.
Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical procedures planned during the course of 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.
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Kenkel, MD | UT Southwestern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Participants- Single Treatment Group | Subjects will receive 1 BBL/MOXI/HALO treatments. Overall assessments will be collected before the first treatment and at subsequent follow-up visits at 1 Month and 3 Months post final treatment. Sciton Joule System: Sciton Joule System |
| FG001 | Healthy Participants- Double Treatment Group | Subjects will receive 2 BBL/MOXI/HALO treatments. All 2nd treatments will be scheduled 4-8 weeks after the initial treatment to ensure the skin has enough time to recover. Overall assessments will be collected before the first treatment and at subsequent follow-up visits at 1 Month and 3 Months post final treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Single treatment (4 weeks) |
| |||||||||||||
| Double treatment (8 weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Treatment Arm | Subjects will receive a single treatment of BBL/MOXI/HALO Sciton Joule System: Sciton Joule System |
| BG001 | Double Treatment Arm | Subjects will receive double treatment of BBL/MOXI/HALO 4-6 weeks apart. Sciton Joule System: Sciton Joule System |
| 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 Brown Spots at 1 Month From Baseline (Single Treatment Group) | Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of spots | Baseline, 1 Month |
|
4 months
similar treatment parameters allowed for overall assessment
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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 | Single Treatment Group Participants | all reportable events for all patients who underwent single treatment (1 BBL/MOXI/HALO treatments) |
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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 21, 2024 | Jun 4, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Subjects will receive 1-2 combination treatments.
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PI will assess subject after a single treatment and decide if a second treatment is necessary.
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| Baseline, 3 Months |
| Change in Pores at 1 Month From Baseline (Double Treatment Group) | Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Baseline, 1 Month |
| Change in Pores at 3 Months From Baseline (Double Treatment Group) | Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Baseline, 3 Months |
| Change in Porphyrins at 1 Month From Baseline (Single Treatment Group) | Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Baseline, 1 Month |
| Change in Porphyrins at 3 Months From Baseline (Single Treatment Group) | Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Baseline, 3 Months |
| Change in Porphyrins at 1 Month From Baseline (Double Treatment Group) | Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Baseline, 1 Month |
| Change in Porphyrins at 3 Months From Baseline (Double Treatment Group) | Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Baseline, 3 Months |
| Change in Red Features at 1 Month From Baseline (Single Treatment Group) | Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Baseline, 1 Month |
| Change in Red Features at 3 Months From Baseline (Single Treatment Group) | Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Baseline, 3 Months |
| Change in Red Features at 1 Month From Baseline (Double Treatment Group) | Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Baseline, 1 Month |
| Change in Red Features at 3 Months From Baseline (Double Treatment Group) | Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Baseline, 3 Months |
| Change in Texture at 1 Month From Baseline (Single Treatment Group) | Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit | Baseline, 1 Month |
| Change in Texture at 3 Months From Baseline (Single Treatment Group) | Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit | Baseline, 3 Months |
| Change in Texture at 1 Month From Baseline (Double Treatment Group) | Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit | Baseline, 1 Month |
| Change in Texture at 3 Months From Baseline (Double Treatment Group) | Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit | Baseline, 3 Months |
| Change in UV Spots at 1 Month From Baseline (Single Treatment Group) | Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Baseline, 1 Month |
| Change in UV Spots at 3 Months From Baseline (Single Treatment Group) | Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Baseline, 3 Months |
| Change in UV Spots at 1 Month From Baseline (Double Treatment Group) | Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Baseline, 1 Month |
| Change in UV Spots at 3 Months From Baseline (Double Treatment Group) | Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Baseline, 3 Months |
| Change in Visible Spots at 1 Month From Baseline (Single Treatment Group) | Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Baseline, 1 Month |
| Change in Visible Spots at 3 Months From Baseline (Single Treatment Group) | Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Baseline, 3 Months |
| Change in Visible Spots at 1 Month From Baseline (Double Treatment Group) | Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Baseline, 1 Month |
| Change in Visible Spots at 3 Months From Baseline (Double Treatment Group) | Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Baseline, 3 Months |
| Change in Total Wrinkle Area at 1 Month From Baseline (Single Treatment Group) | Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Baseline, 1 Month |
| Change in Total Wrinkle Area at 3 Months From Baseline (Single Treatment Group) | Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Baseline, 3 Months |
| Change in Total Wrinkle Area at 1 Month From Baseline (Double Treatment Group) | Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Baseline, 1 Month |
| Change in Total Wrinkle Area at 3 Months From Baseline (Double Treatment Group) | Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Baseline, 3 Months |
| NOT COMPLETED |
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| 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) | 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 Brown Spots at 3 Months From Baseline (Single Treatment Group) | Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of spots | Baseline, 3 Months |
|
|
|
| Primary | Change in Brown Spots at 1 Month From Baseline (Double Treatment Group) | Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of spots | Baseline, 1 Month |
|
|
|
| Primary | Change in Brown Spots at 3 Months From Baseline (Double Treatment Group) | Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of spots | Baseline, 3 Months |
|
|
|
| Primary | Change in Pores at 1 Month From Baseline (Single Treatment Group) | Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of pores | Baseline, 1 Month |
|
|
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| Primary | Change in Pores at 3 Months From Baseline (Single Treatment Group) | Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of pores | Baseline, 3 Months |
|
|
|
| Primary | Change in Pores at 1 Month From Baseline (Double Treatment Group) | Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of pores | Baseline, 1 Month |
|
|
|
| Primary | Change in Pores at 3 Months From Baseline (Double Treatment Group) | Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of pores | Baseline, 3 Months |
|
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| Primary | Change in Porphyrins at 1 Month From Baseline (Single Treatment Group) | Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of porphyrins | Baseline, 1 Month |
|
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| Primary | Change in Porphyrins at 3 Months From Baseline (Single Treatment Group) | Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of porphyrins | Baseline, 3 Months |
|
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| Primary | Change in Porphyrins at 1 Month From Baseline (Double Treatment Group) | Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of porphyrins | Baseline, 1 Month |
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| Primary | Change in Porphyrins at 3 Months From Baseline (Double Treatment Group) | Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of porphyrins | Baseline, 3 Months |
|
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| Primary | Change in Red Features at 1 Month From Baseline (Single Treatment Group) | Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Analysis was focused on testing whether the effect of the treatment on each parameter differed Frontal- 2 subjects data was incomplete. Left- 1 subject data was incomplete The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of red features | Baseline, 1 Month |
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| Primary | Change in Red Features at 3 Months From Baseline (Single Treatment Group) | Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Analysis was focused on testing whether the effect of the treatment on each parameter differed Frontal- 2 subjects data was incomplete. Left- 1 subject data was incomplete The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of red features | Baseline, 3 Months |
|
|
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| Primary | Change in Red Features at 1 Month From Baseline (Double Treatment Group) | Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Analysis was focused on testing whether the effect of the treatment on each parameter differed Frontal- 2 subjects data was incomplete. Left- 1 subject data was incomplete The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of red features | Baseline, 1 Month |
|
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| Primary | Change in Red Features at 3 Months From Baseline (Double Treatment Group) | Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Analysis was focused on testing whether the effect of the treatment on each parameter differed Frontal- 2 subjects data was incomplete. Left- 1 subject data was incomplete The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of red features | Baseline, 3 Months |
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| Primary | Change in Texture at 1 Month From Baseline (Single Treatment Group) | Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | unitless | Baseline, 1 Month |
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| Primary | Change in Texture at 3 Months From Baseline (Single Treatment Group) | Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | unitless | Baseline, 3 Months |
|
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| Primary | Change in Texture at 1 Month From Baseline (Double Treatment Group) | Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | unitless | Baseline, 1 Month |
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| Primary | Change in Texture at 3 Months From Baseline (Double Treatment Group) | Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | unitless | Baseline, 3 Months |
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| Primary | Change in UV Spots at 1 Month From Baseline (Single Treatment Group) | Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of UV spots | Baseline, 1 Month |
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| Primary | Change in UV Spots at 3 Months From Baseline (Single Treatment Group) | Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of UV spots | Baseline, 3 Months |
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| Primary | Change in UV Spots at 1 Month From Baseline (Double Treatment Group) | Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of UV spots | Baseline, 1 Month |
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| Primary | Change in UV Spots at 3 Months From Baseline (Double Treatment Group) | Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of UV spots | Baseline, 3 Months |
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| Primary | Change in Visible Spots at 1 Month From Baseline (Single Treatment Group) | Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of visible spots | Baseline, 1 Month |
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| Primary | Change in Visible Spots at 3 Months From Baseline (Single Treatment Group) | Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of visible spots | Baseline, 3 Months |
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| Primary | Change in Visible Spots at 1 Month From Baseline (Double Treatment Group) | Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of visible spots | Baseline, 1 Month |
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| Primary | Change in Visible Spots at 3 Months From Baseline (Double Treatment Group) | Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement | Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | count of visible spots | Baseline, 3 Months |
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| Primary | Change in Total Wrinkle Area at 1 Month From Baseline (Single Treatment Group) | Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Analysis was focused on testing whether the effect of the treatment on each parameter differed Nose- 1 subject didn't have complete data thus it was not included in analysis The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | mm^2 | Baseline, 1 Month |
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| Primary | Change in Total Wrinkle Area at 3 Months From Baseline (Single Treatment Group) | Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Analysis was focused on testing whether the effect of the treatment on each parameter differed Nose- 1 subject didn't have complete data thus it was not included in analysis The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | mm^2 | Baseline, 3 Months |
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| Primary | Change in Total Wrinkle Area at 1 Month From Baseline (Double Treatment Group) | Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Analysis was focused on testing whether the effect of the treatment on each parameter differed Nose- 1 subject didn't have complete data thus it was not included in analysis The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | mm^2 | Baseline, 1 Month |
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| Primary | Change in Total Wrinkle Area at 3 Months From Baseline (Double Treatment Group) | Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement. | Analysis was focused on testing whether the effect of the treatment on each parameter differed Nose- 1 subject didn't have complete data thus it was not included in analysis The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed. | Posted | Median | Inter-Quartile Range | mm^2 | Baseline, 3 Months |
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Double Treatment Group Participants | all reportable events for all patients who underwent double treatment (2 BBL/MOXI/HALO treatments) | 0 | 8 | 0 | 8 | 0 | 8 |
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