Fractionated 1927nm Laser for Diffuse Pigmentation and Actinic Changes.

Investigating the Efficacy of a Fractionated 1927nm Laser for Diffuse Pigmentation and Actinic Changes

This is a single-site, non-randomized, non-controlled study at UT Southwestern Medical Center at Dallas in the Department of Plastic Surgery designed to follow up to 30 qualified and consenting subjects receiving a fractionated 1927 combination treatments for diffuse hyperpigmentation and/or melasma. Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months, followed by two follow-up visits at 1-month and 3-months post-treatment.

This is a prospective, non-controlled study where subjects will receive treatment using f1927 devices and will be treated twice over the affected areas of the face once each month for a total of two months. Patients will be evaluated at 1-month and 3-months post-treatment to monitor the clinical effects of treatment. Overall assessment of treatment efficacy will be based on evaluation of standard and close-up photography using pre- and post-procedural photos as well as images obtained by the Vectra H2 3D Imaging System. Baseline changes in the visualization and numeric analysis of pigmented areas will be evaluated utilizing the 3D Facial Skin Analysis software on the H2 System. Subjects will also undergo non-invasive skin measurements using optical coherence tomography (OCT) to noninvasively gather topographical and histological images of pre- and post-treated skin. Screening, treatment(s) with f1927, and OCT measurements are all for research purposes.

Inclusion Criteria:

1. Healthy male and female adults between 20-60 years of age.

2. Fitzpatrick skin type I-IV.

3. Individuals deemed by the Investigator to have a significant amount of pigmentation/melasma and that desire correction of this condition.

4. Individuals willing to withhold aesthetic therapies, or other therapies judged to potentially impact results to the treatment areas for the duration of the study.

5. 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 of the following is documented - postmenopausal for at least 12 months prior to study, without a uterus and/or both ovaries, bilateral tubal ligation at least 6 months prior to study enrollment

6. Individuals of childbearing potential who use an acceptable method of contraception throughout the study. Acceptable methods of birth control include:

   • Established use of hormonal contraception (oral, injected, implanted, patch or vaginal ring)
   • Barrier methods with spermicide: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
   • Intrauterine device (IUD) or intrauterine system (IUS)
   • Surgical sterilization (e.g. vasectomy confirmed to be effective by sperm count check, tubal occlusion, hysterectomy, bilateral salpingectomy/oophorectomy)
   • Abstinence from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal methods are not acceptable forms of contraception

7. Individuals who can read, speak, write and understand English and who are willing to provide written informed consent.

8. Individuals willing to sign a photography release.

9. 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 lidocaine or ester-based local anesthetics.

4. Active systemic or local conditions that may affect wound healing.

5. Current or recent history of inflammatory skin disease, infection or unhealed wound in the proposed treatment area(s).

6. History of systemic granulomatous diseases, either active or inactive, (e.g. Sarcoid, Wegener's, TB, etc.) or connective tissue diseases (e.g. lupus, dermatomyosistis, etc.).

7. Recent history of significant trauma to the areas to be treated (< 6 months).

8. Significant scarring, other than acne scars, in the area(s) to be treated.

9. Current or history of hypertrophic scarring or keloid scars.

10. Severe or cystic and clinically significant acne on the area(s) to be treated.

11. Tattoos in the area to be treated.

12. Observable suntan, nevi, excessive hair, etc. or other dermal conditions on the treatment area(s) of the face that might influence study results in the opinion of the Investigator.

13. Individuals who currently have cancerous or pre-cancerous lesions in the area(s) to be treated and/or with a history of skin cancer.

14. 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.

15. History of chronic drug or alcohol use.

16. 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.

17. History of the following cosmetic treatments in the area(s) to be treated:

    • Injectable filler of any type within the past 2 weeks
    • Neurotoxins within the past week
    • Ablative resurfacing laser treatment within the past 6 months
    • Non-ablative, rejuvenative laser or light treatment within the past 6 months
    • Chemical peel or dermabrasion within the past 3 months

18. Individuals undergoing concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study devices.

19. History of using the following prescription medications:

    • Accutane or other systemic retinoids within the past 6 months
    • Topical retinoids within the past 4 weeks
    • Prescription strength lightening devices (e.g. hydroquinone, tretinoin, AHA, BHA, poly-hydroxy acids, 4-hydroxyanisole alone or combined with tretinoin, etc.) within 4 months
    • Any anti-wrinkle or skin lightening devices, or topical or systemic medication known to affect skin aging or dyschromia (e.g. devices containing alpha/beta/polyhydroxy acids, Vitamin C, soy, Q-10, hydroquinone, systemic or licorice extract (topically), Tego ®, Cosmo C250, gigawhite, lemon juice extract (topically), embilica extract, etc.) within 2 weeks
    • 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.

20. Individuals who are pregnant or nursing or those planning on becoming pregnant during the study according to self-report.

21. Immunocompromised individuals or those currently using immunosuppressive medications and/or radiation.

22. 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.

23. Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical procedures planned during the course of the study.

24. Individuals who, in the Investigator's opinion, have a history of poor cooperation, unreliability or noncompliance with medical treatment.

25. Individuals who are unable to understand instructions or give informed consent

26. 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).