Clinical and Histological Evaluation of… | Clinical Trial

Key information

Conditions

Facial Rejuvenation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology and Laser Surgery

Sacramento, California, 95819, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Is a healthy male or female between 18 and 65 years old
Is willing to consent to participate in the study.
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

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.
The subject is hypersensitive to light exposure OR takes photo sensitized medication.
The subject has active or localized systemic infections.
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}).
The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
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.
The subject has used Accutane within 6 months prior to enrollment.
The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
The subject has a history of keloids.
The subject has evidence of compromised wound healing.
The subject has a history of squamous cell carcinoma or melanoma.
The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
The subject has an allergy to lidocaine and epinephrine.

Treatment and study plan

755nm Laser with Cap Array

Device

Primary outcomes

Changes in Facial Scarring Score

Time frame: Baseline and 3 months post last treatment

Physicians will examine the subjects' facial scarring using the Physician Global Scarring Grading (PGSG) scale. This scale counts and types scars by tallying up of the number and severity of the scars according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement).
Photodamage Score Change

Time frame: Baseline and 3 months post last treatment

The photodamage is assessed by examining fine wrinkles, mottled hyperpigmentation, and overall integrated assessment of photodamage. These 3 categories are broken down into their own scales of 0 to 4 based on severity. 0 indicates none, 1 indicates minimal, 2 indicates mild, 3 indicates moderate, and 4 indicates severe. The total points from all 3 categories added up will range from 0 to 12, where 12 is the most photodamage possible. A decrease in score indicates less photodamage.
Number of Participants With Signs of New Collagen Generations

Time frame: 3 months post last treatment

Subjects will have one 3mm punch biopsy obtained pretreatment from an inconspicuous area and subsequent biopsies at one or any of the following visits after treatment. Pathologies will be provided by pathologists who are able to determine any developments of dermal mucus, dermal elastic fibers, or changes in collagen III. An increase in any of these categories corresponds with skin rejuvenation.

Sponsors and collaborators

Lead sponsor

Cynosure, Inc.

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Apr 8, 2014
Registry last updated: Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed