Pigment Skin
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICESciton Joule System
Sciton Joule System
Sponsors
University of Texas Southwestern Medical Center
Sciton
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
PI will assess subject after a single treatment and decide if a second treatment is necessary.
Intervention model description
Subjects will receive 1-2 combination treatments.
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male and female adults between 20-75 years of age 2. Fitzpatrick skin type 1-4 3. Individual deemed by the Investigator to benefit from skin resurfacing treatment(s) 4. Individuals willing to withhold aesthetic therapies that may potentially impact results to the treatment areas for the duration of the study 5. 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 * Hormonal contraception (oral, injected, implanted, patch or vaginal ring) * Barrier method with spermicide: condom or occlusive cap with spermicidal foam/gel/cream/suppository * Intrauterine device (IUD) * Surgical Sterilization (e.gh., vasectomy, tubal occlusion, hysterectomy, bilateral salpingectomy/oophorectomy) * Abstinence from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject. Periodical abstinence and withdrawal methods are not acceptable forms of contraception. 6. Individuals who can read, speak, write and understand English and who are willing to provide written informed consent. 7. 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 8. Individuals willing and able to cooperate with all study requirements for the duration of the study.
Exclusion criteria
1. Fitzpatrick skin type V-VI 2. Known allergies to general skin care products 3. Sensitivity to topical local anesthetic 4. 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.) 5. Significant scars in the treatment area: * Severe or cystic and clinically significant acne or acne scars on the areas to be treated * Current or history of hypertrophic scarring or keloid scars 6. Tattoos in the area to be treated 7. Observable suntan, nevi, excessive hair, etc., or other dermal conditions that might influence study results on the face in the opinion of the Investigator 8. Individuals who currently have cancerous or pre-cancerous lesions in the area to be treated 9. 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. 10. History of chronic drug or alcohol use 11. Recent aesthetic treatments: * \<4 weeks of microdermabrasion or glycolic acid treatment to the treatment area or who plan to have this treatment during the study * \<2 weeks of any type of injectable filler * \<1 week of neurotoxin's * \<6 months of ablative resurfacing laser treatments * \<6 months of non-ablative, rejuvenative laser or light treatment * \<3 months of chemical peels or dermabrasion 12. Use of the following prescription medications: * \<6 weeks of Accutane or other systemic retinoids on the treatment area * \<4 weeks of topical retinoids * \<4 months of prescription strength lightening medications (e.g., hydroquinone, tretinoin, AHA, BHA, poly-hydroxy acids, 4-hydroxyanisole alone or in combination with tretinoin) * \<2 weeks of anti-wrinkle or skin lightening or topical systemic medication known to affect skin aging or dyschromia (e.g., alpha/beta/polyhydroxy acids, Vitamin C, soy, Q-10; hydroquinone, etc.,), TEGO, Cosmo C250, gigawhite, lemon juice extract (topically), or embilica extract * Antiplatelet agents/anticoagulant (Coumadin, Heparin, Plavix, chronic NSAID use) * Psychiatric drugs that would impair the subject from understanding protocol requirements or understanding and signing the ICF. 13. Individuals who are pregnant or planning to become pregnant during the course of the study 14. Immunocompromised individuals or those currently using immunosuppressive medications and/or radiation 15. Individuals with uncontrolled disease such as asthma, diabetes, hyperthyroidism, medically significant hypertension, or hypothyroidism. 16. Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical procedures planned during the course of the study. 17. Individuals who, in the Investigator's opinion, have a history of poor cooperation, unreliability or noncompliance with medical treatment. 18. Individuals who are unable to understand instructions or give informed consent 19. Individuals who have physical or psychological conditions which, in the opinion of the Investigator, makes them unable to complete the study per protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brown Spots at 1 Month From Baseline (Single Treatment Group) | Baseline, 1 Month | 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 |
| Change in Brown Spots at 3 Months From Baseline (Single Treatment Group) | Baseline, 3 Months | 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 |
| Change in Brown Spots at 1 Month From Baseline (Double Treatment Group) | Baseline, 1 Month | 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 |
| Change in Brown Spots at 3 Months From Baseline (Double Treatment Group) | Baseline, 3 Months | 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 |
| Change in Pores at 1 Month From Baseline (Single Treatment Group) | Baseline, 1 Month | 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. |
| Change in Pores at 3 Months From Baseline (Single Treatment Group) | Baseline, 3 Months | 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. |
| Change in Pores at 1 Month From Baseline (Double Treatment Group) | Baseline, 1 Month | 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 |
| Change in Pores at 3 Months From Baseline (Double Treatment Group) | Baseline, 3 Months | 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. |
| Change in Porphyrins at 1 Month From Baseline (Single Treatment Group) | Baseline, 1 Month | 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. |
| Change in Porphyrins at 3 Months From Baseline (Single Treatment Group) | Baseline, 3 Months | 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. |
| Change in Porphyrins at 1 Month From Baseline (Double Treatment Group) | Baseline, 1 Month | 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. |
| Change in Porphyrins at 3 Months From Baseline (Double Treatment Group) | Baseline, 3 Months | 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. |
| Change in Red Features at 1 Month From Baseline (Single Treatment Group) | Baseline, 1 Month | 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 |
| Change in Red Features at 3 Months From Baseline (Single Treatment Group) | Baseline, 3 Months | 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 |
| Change in Red Features at 1 Month From Baseline (Double Treatment Group) | Baseline, 1 Month | 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 |
| Change in Red Features at 3 Months From Baseline (Double Treatment Group) | Baseline, 3 Months | 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 |
| Change in Texture at 1 Month From Baseline (Single Treatment Group) | Baseline, 1 Month | 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 |
| Change in Texture at 3 Months From Baseline (Single Treatment Group) | Baseline, 3 Months | 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 |
| Change in Texture at 1 Month From Baseline (Double Treatment Group) | Baseline, 1 Month | 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 |
| Change in Texture at 3 Months From Baseline (Double Treatment Group) | Baseline, 3 Months | 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 |
| Change in UV Spots at 1 Month From Baseline (Single Treatment Group) | Baseline, 1 Month | 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 |
| Change in UV Spots at 3 Months From Baseline (Single Treatment Group) | Baseline, 3 Months | 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 |
| Change in UV Spots at 1 Month From Baseline (Double Treatment Group) | Baseline, 1 Month | 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 |
| Change in UV Spots at 3 Months From Baseline (Double Treatment Group) | Baseline, 3 Months | 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 |
| Change in Visible Spots at 1 Month From Baseline (Single Treatment Group) | Baseline, 1 Month | 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 |
| Change in Visible Spots at 3 Months From Baseline (Single Treatment Group) | Baseline, 3 Months | 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 |
| Change in Visible Spots at 1 Month From Baseline (Double Treatment Group) | Baseline, 1 Month | 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 |
| Change in Visible Spots at 3 Months From Baseline (Double Treatment Group) | Baseline, 3 Months | 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 |
| Change in Total Wrinkle Area at 1 Month From Baseline (Single Treatment Group) | Baseline, 1 Month | 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. |
| Change in Total Wrinkle Area at 3 Months From Baseline (Single Treatment Group) | Baseline, 3 Months | 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. |
| Change in Total Wrinkle Area at 1 Month From Baseline (Double Treatment Group) | Baseline, 1 Month | 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. |
| Change in Total Wrinkle Area at 3 Months From Baseline (Double Treatment Group) | Baseline, 3 Months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJeffrey Kenkel, MD
UT Southwestern
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 8 |
| other Total, other adverse events | 0 / 7 | 0 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 |
Outcome results
None listed