Evaluation of the 755nm Alexandrite for the Treatment of Epidermal and Dermal Pigmented Lesions

NCT01754233 | Completed

• 1 other identifier: CYN12-PICO-PL
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess treatment for facial dermal and epidermal pigmented lesions using the 755nm Alexandrite laser.

Conditions

Dermal and Epidermal Pigmented Lesions

Outcome Measures

Primary Outcomes (1)

• Photographic Evaluation

  up to 4 months post last treatment

Secondary Outcomes (2)

• Reporting of Adverse Events

  up to 4 months post last treatment

• Satisfaction Questionnaire

  up to 4 months post treatment

Study Arms (1)

755nm Alexandrite Laser

EXPERIMENTAL

755nm Alexandrite Laser

Device: 755nm Alexandrite Laser

Interventions

755nm Alexandrite Laser DEVICE

755nm Alexandrite Laser for epidermal and dermal pigmented lesions

755nm Alexandrite Laser

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a healthy male or female between 18 and 85 years old
• Has unwanted dermal and/or epidermal pigmented lesions or desires skin toning and wishes to undergo laser treatments.
• Is willing to consent to participate in the study.
• Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
• Has Fitzpatrick skin types III to IV.

You may not qualify if:

• 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 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 subjects had prior treatment with laser or other devices in the treatment area within 3 months.
• The subject has a history of keloids or hypertrophic scarring.
• 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.
• Is allergic to topical lidocaine or topical steroids.

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (1)

Skin Care Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

MeSH Terms

Interventions

Lasers, Solid-State

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Patricia Krantz

  Cynosure, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 21, 2012
• Study Start: December 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 26, 2020

Record last verified: 2020-10

Locations

US (1)