Clinical trial NCT01813760: Treatment of Periorbital and Perioral Wrinkles With the Applications of the Iluminage Diode Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-orbital Wrinkles
Peri-oral Wrinkles
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Diode laser system is being used in this marketing study for the treatment of wrinkles around the eyes and mouth.


Eligibility criteria: Inclusion Criteria:

1. Subjects who are healthy females between 35 and 60 years of age.
2. Subjects who have Fitzpatrick skin type I-VI
3. Subjects who have provided written and verbal informed consent
4. Subjects who are willing and able to comply with study instructions and to return to the clinic for required visits and have photographs of their face taken
5. Subjects who have perioral and periorbital wrinkles, as deemed appropriate by the Investigator or his designees

Exclusion Criteria:

1. Subjects who currently use or have used in the prior 30 days any skin products that contain alpha hydroxy acids (AHA) e.g. glycolic, lactic, citric, or mendelic acid containing products or retinol/tretinoin containing products or exfoliating washes, masks or scrubs or other micro-dermabrasion skin care products. on the laser application areas
2. Subjects who are unwilling to maintain their daily skin care regimen for the duration of the study,
3. Subjects who have any skin pathology or condition that could interfere with the evaluation i.e. personal or family history of skin cancer, rosacea and/or requires the use of interfering topical or systemic therapies.
4. Subjects with synthetic or metal implants or permanent cosmetic tattoos in the test areas
5. Subjects who have a history of abnormal scarring, e.g. keloids or have significant scarring in the areas to be treated
6. Subjects with bleeding disorders or taking anticoagulation medications, including heavy use of aspirin
7. Subjects who have participated in any clinical investigation involving the face within the 30 days prior to the first planned laser application or subjects who plan to participate in concomitant facial studies during this trial
8. Subjects, who are pregnant, were pregnant or gave birth in the last 3 months, are currently breast feeding, or might become pregnant during the course of the study
9. Subjects who have a history of light triggered seizures
10. Subjects with prior use of neurotoxins e.g. Botox®, collagen, fat injections and/or other methods of skin augmentation (enhancement with injected or implanted material) of the face or having had chemical peels within 6 months of initial laser application or planning to so during the course of the study
11. Subject's use of oral isotretinoin (Accutane®) within 12 months of initial laser application or during the course of the study
12. Subjects having had facial skin treatments with any professional laser, light based, radiofrequency or other devices within the last year
13. Subjects ever having facial skin treatments with home use laser, light based or radiofrequency or other devices, i.e. PaloVia® or Tria®

Primary outcomes:
measure: Photographic Evaluation
timeFrame: 60 days post first treatment
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: up to 4 months post 1st treatment
measure: Photographic Evaluation
timeFrame: Up to 40 days
Other outcomes:
Locations:
city: Westford
country: United States
facility: Cynosure, Inc
state: Massachusetts
Study officials:
affiliation: Cynosure, Inc.
name: Patricia Krantz
role: STUDY_DIRECTOR
References: