Photodamage
Conditions
Keywords
Hyperpigmentation, Telangiectasias
Brief summary
Both the Dye - VL 500 - 600 nm and the Dual band will improve significantly the appearance of Photo Damage with high efficacy including; safety, minimal discomfort and downtime.
Interventions
DEVICESingle Band vs. Dual Band Pulsed Light Technology for the Treatment of Photodamage
Sponsors
Alma Lasers Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Age
35 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
The following are requirements for a potential subject's inclusion into the study: * Male or female in good general health between 35 to 65 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: Clinical diagnosis of photo damage affecting the face. * 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. * Must be willing to comply with study visits and complete the entire course of the study.
Exclusion criteria
Subjects meeting any of the following criteria will be excluded from participation: The following are
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Photodamage | The investigator will evaluate the change in visual appearance of the treated area at 3 week, 6 week, 9 week treatments and before follow-up visit (3 months after the last treatment) | Investigator Evaluation of Specific Signs of Photo Damage 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% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Photodamage | Investigator will evaluate the change in visual appearance of the treated area at 3 week, 6 week, 9 week treatments, and before follow up visit (three months after the last visit) | Investigator Evaluation of Specific Signs of Photo Damage In addition, the Investigator will at each visit complete the Investigator Evaluation of Specific Signs of Photo Damage as seen below (for each of the handpieces): Poilikoderma of Civatte * None (0) = Normal * Trace (1) = Barely visible and localized * Mild (2) = Somewhat visible and diffuse * Moderate (3) = Visible and diffuse * Severe (4) = Extremely visible and dense Telangiectasias * None (0) = Normal * Trace (1) = Barely visible and localized * Mild (2) = Somewhat visible and diffuse * Moderate (3) = Visible and diffuse * Severe (4) = Extremely visible and dense Pigmented components of Photo Damage * None (0) = Normal * Trace (1) = Barely visible and localized * Mild (2) = Somewhat visible and diffuse |
Countries
United States
Outcome results
None listed