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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Harmony Dye-VL 500-600nm | Active Comparator | The left side of the face will be treated with the Single Band Alma Harmony Dye-VL 500-600nm device. Three treatments, administered in intervals of 21 +/- 2 days. Each full face treatment duration will be approximately 20-30 minutes . |
|
| Palomar MaxG | Active Comparator | Right side of the face will be treated with the Dual Band Palomar MaxG device. Three treatments, administered in intervals of 21 +/- 2 days. Each full face treatment duration will be approximately 20-30 minutes . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Band vs. Dual Band Pulsed Light Technology for the Treatment of Photodamage | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Photodamage | 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
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Photodamage | 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
Telangiectasias
Pigmented components of Photo Damage
|
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Inclusion Criteria:
The following are requirements for a potential subject's inclusion into the study:
Clinical diagnosis of photo damage affecting the face.
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from participation:
The following are exclusion criteria for subjects in this study:
A subject that underwent a laser / light treatment on the face within 12 months, or any topical treatment on the face within 6 months.
A subject with any UNCONTROLLED systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
A subject with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
A subject using any topical product containing a retinoid, retinol, or other vitamin A derivative within 3 months prior to or during the study period.
A subject using any systemic steroid therapy within 6 months prior to or during the study period.
A subject that has been treated with Botox/Dysport or filler/biostimulatory molecule injections to his/her face within the past 6 months.
A subject using any topical medicated creams, lotions, powders, etc. on the treatment areas during the study period, other than the study treatment regimen within 14 days.
A subject that has previously been treated with systemic retinoids within the past year (e.g., Accutane®, Roche Dermatologics).
A subject with recently excessive facial exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing). During the study, when excessive sun exposure is unavoidable, subjects must wear appropriate protective clothing (e.g. hat, collar) and comply with the study dosing regimen of daily application of the dispersed sunblock.
A subject with a recent history or active presence of any facial skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e. moderate to severe acne vulgaris, atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis, excessive facial hair or coloration).
A female subject who is pregnant, nursing an infant or planning a pregnancy during the study [throughout the course of the study, women of child-bearing potential must use reliable forms of contraception (i.e., oral contraceptive, intrauterine device, abstinence, or spermicides and condoms used in combination)].
Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
Subjects who are pregnant, breast-feeding, or planning a pregnancy. Females of childbearing potential, must be either:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Laser & Surgery Specialists of NY/NJ | Hackensack | New Jersey | 07601 | United States |
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| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D013684 | Telangiectasis |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014652 | Vascular Diseases |
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| 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) |
| D002318 | Cardiovascular Diseases |