Study of a Novel Laser for Skin Rejuvenation
Maneno muhimu
Kikemikali
Maelezo
A single-center prospective, open-label uncontrolled exploratory study to evaluate the safety and efficacy of an investigational version of the enlighten™ 670nm laser for photo-rejuvenation.
Subjects will receive up to 7 laser treatments, spaced 1 to 8 weeks apart, and will be followed at 2 weeks (±1 week) post-first treatment and 12 weeks (±2 weeks) post-final treatment. In addition, after each treatment, subjects will complete a 3 day post treatment phone follow-up. At the Investigator's discretion, optional follow-up visits may also be conducted at 6 weeks post-final treatment (±2 weeks).
Tarehe
| Imethibitishwa Mwisho: | 08/31/2016 |
| Iliyowasilishwa Kwanza: | 09/15/2016 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 09/19/2016 |
| Iliyotumwa Kwanza: | 09/21/2016 |
| Sasisho la Mwisho Liliwasilishwa: | 12/13/2017 |
| Sasisho la Mwisho Lilichapishwa: | 12/17/2017 |
| Tarehe halisi ya kuanza kwa masomo: | 08/31/2016 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 05/31/2018 |
| Tarehe ya Kukamilisha Utafiti: | 08/31/2018 |
Hali au ugonjwa
Uingiliaji / matibabu
Device: Investigational Enlighten Device
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Experimental: Investigational Enlighten Device Laser treatment for facial skin rejuvenation with the experimental enLighten Laser | Device: Investigational Enlighten Device Nd:YAG dual-pulse duration laser for the treatment of skin rejuvenation |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 20 Years Kwa 20 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: - Female or Male, 20 to 75 years of age (inclusive). - Fitzpatrick Skin Type I - VI. - Desires photo-rejuvenation of the skin or improvement in the appearance of acne scarring. - Subject has visible signs of acne scarring or moderate sun-damaged and/or aging skin in the treatment area with visible areas acne lesions and scars, fine rhytides, lentigines or pigmentation, diffused redness erythema and skin texture - Subject must be able to read, understand and sign the Informed Consent Form. - Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions. - Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treatment area every day for the duration of the study, including the follow-up period. - Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes. - Agree to not undergo any other procedure(s), including injectable agents, for skin rejuvenation during the study and has no intention of having such procedures performed during the course of the study. - Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant. Exclusion Criteria: - Participation in a clinical trial of another drug, or device administered to the target area, during the study. - Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser or light-based procedures or surgery. - Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler within 6 months of study participation. - History of malignant tumors in the target area. - Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, large moles. - Pregnant and/or breastfeeding. - Having an infection, dermatitis or a rash in the treatment area. - Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension. - History of keloid scarring, hypertrophic scarring or of abnormal wound healing. - History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications per investigator's discretion. - History of vitiligo, eczema, or psoriasis. - History of connective tissue disease, such as systemic lupus erythematosus or scleroderma. - History of seizure disorders due to light. - Any use of medication that is known to increase sensitivity to light according to Investigator's discretion. - History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen - History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation. - Systemic use of retinoid, such as isotretinoin, as applicable, within 6 months of study participation. - Topical use of retinoid, such as isotretinoin, as applicable, on the treatment area within 1 month of participation. - Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus. - Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study. - Current smoker or history of smoking within 6 months of study participation. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study. |
Matokeo
Hatua za Matokeo ya Msingi
1. Adverse Device Effects at 2 weeks post-first treatment. [2 weeks post-first treatment]
Hatua Nyingine za Matokeo
1. Degree of improvement as assessed by the Investigator (Physician's Global Assessment of Improvement). [12 weeks post-final treatment]
2. Subject Satisfaction as assessed by Subject Satisfaction Assessment Scale [12 weeks post-final treatment]
