Photodamage
Conditions
Keywords
Hyperpigmentation, telangiectasias
Brief summary
To assess the safety and efficacy of light-laser combination therapy for the improvement of skin color, tone, texture and laxity
Detailed description
This is a prospective study to test the safety and efficacy of a three different light and laser handpieces for the improvement of skin color, tone, texture and laxity. All subjects will receive up to four treatments, administered in intervals of 28 +/- 2 days. Each full face treatment duration will be approximately 60 minutes. The initial power and number of passes parameters shall be set according to the clinical indication and skin type of the subject treated. The treatment area will be cleaned and photographed before each treatment. Photographs will be taken at baseline, prior to each treatment and during each follow-up visit. Before the initiation of the first treatment each subject will undergo clinical evaluation. Clinical improvement will be assessed by the investigator from the visual appearance of the treated area and from the fixed magnification clinical photographs according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement. Adverse side effects will be scored by clinical evaluation of erythema, edema, and burns. Treatments and results will be documented in a Case Report Form at each treatment session and follow-up session (1 month and 3 months after the last treatment). In case of adverse side effects and symptoms other than erythema or edema appear during or following a treatment, the next treatment may be skipped by two weeks or treatment parameters reduced until symptoms resolve. If adverse side effects are observed, the investigator should provide the subject with the proper care and remedy and will document it in the Case Report Form.
Interventions
DEVICEAssess the safety and efficacy of light-laser therapy using the Harmony XL and Dye-VL (500-600nm), Q-Switched 1064nm, Er:YAG 2940nm modules in combination .
Sponsors
Alma Lasers Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female in good general health between 35 to 60 years of age. * Must be willing to execute informed consent. Patient must also consent to having photos taken at each visit. * A potential subject must exhibit: Facial wrinkling and graded mild to moderate overall rough texture, large pores, and/or skin laxity. * For FEMALE PATIENTS OF CHILDBEARING POTENTIAL, must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation) and is willing to use an acceptable form of birth control during the entire course of the study \[i.e., acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplanit®, Depo-Provena®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the subject become sexually active\]. All systemic birth control measures must be in consistent use at least 30 days prior to study participation. * Negative urine pregnancy test results at the time of study entry (if applicable). * Must be willing to comply with study visits and complete the entire course of the study.
Exclusion criteria
* Negative urine pregnancy test results at the time of study entry (if applicable). * Must be willing to comply with study visits and complete the entire course of the study. Subjects meeting any of the following criteria will be excluded from participation: The following are
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual observation of improvement in photoaging | The investigator will evaluate the change in visual appearance of the treated area before one month, two month, and three month treatments and before each follow-up visit (1 month and 3 months after the last treatment). | The investigator will evaluate the clinical improvement from the visual appearance of the treated area and from the fixed magnification clinical photographs according to the following Global Assessment scale (compared to baseline photographs): Global Aesthetic Improvement Scale (GAIS ) Rating Description 1. = Very much improved 75%-99% 2. = Much improved 50%-75% 3= Improved 25%-50% 4= No change 1%-25% 5=Worse \<1% |
Countries
United States
Outcome results
None listed