Clinical trial NCT02107157: Clinical and Histological Evaluation of the Picosure 755nm Laser With Cap Array for Facial Rejuvenation
Official title: Clinical and Histological Evaluation of the Picosure 755nm Laser With Cap Array for Facial Rejuvenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Rejuvenation
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess treatment of facial rejuvenation using the standard hand piece and a Lens Array for the 755nm Alexandrite laser.


Eligibility criteria: Inclusion Criteria:

1. Is a healthy male or female between 18 and 65 years old
2. Is willing to consent to participate in the study.
3. Is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.

Exclusion Criteria:

1. The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
2. The subject is hypersensitive to light exposure OR takes photo sensitized medication.
3. The subject has active or localized systemic infections.
4. The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
6. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
7. The subject has used Accutane within 6 months prior to enrollment.
8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
10. The subject has a history of keloids.
11. The subject has evidence of compromised wound healing.
12. The subject has a history of squamous cell carcinoma or melanoma.
13. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
14. The subject has an allergy to lidocaine and epinephrine.

Primary outcomes:
measure: Changes in Facial Scarring Score
timeFrame: Baseline and 3 months post last treatment
measure: Photodamage Score Change
timeFrame: Baseline and 3 months post last treatment
measure: Number of Participants With Signs of New Collagen Generations
timeFrame: 3 months post last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Dermatology and Laser Surgery
state: California
Study officials:
affiliation: Cynosure, Inc.
name: Patricia Krantz
role: STUDY_DIRECTOR
References:
citation: Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.