Treatment of Periorbital and Perioral Wrinkles With the Applications of the Iluminage Diode Laser

Peri-oral Wrinkles Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813760
• Other study ID #: CYN12-AFF-UL-09
• Status: Completed
• Phase: N/A
• First received: March 12, 2013
• Last updated: March 25, 2014
• Start date: November 2012
• Est. completion date: August 2013

Study information

• Verified date: March 2014
• Source: Cynosure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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®

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peri-oral Wrinkles
• Peri-orbital Wrinkles

Intervention

Device:
• Illuiminage ® Diode Laser
Diode laser for treatment of peri-orbital and peri-oral wrinkles

Locations

Country	Name	City	State
United States	Cynosure, Inc	Westford	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cynosure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Photographic Evaluation	Compare severity of wrinkles from baseline to 60 days post treatment based on Fitpatrick Scale.	60 days post first treatment	No
Secondary	Number of Participants with Adverse Events	Adverse events and side effects will be recorded	up to 4 months post 1st treatment	Yes
Secondary	Photographic Evaluation	Compare severity of wrinkles from baseline to 1,10, 20 and 40 days post treatment based on Fitzpatrick Scale.	Up to 40 days	No