Laser Removal of Age (Sun) Spots on Hands

NCT01885871 | Completed Results

• 1 other identifier: C-13-LPS03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether picosecond laser is effective in the treatment of age (sun) spots.

Conditions

Solar Lentigines

Keywords

Sun; Age; Spot

Outcome Measures

Primary Outcomes (1)

• Median VAS Improvement Score as Assessed by Blinded Physician Reviewers

  Improvement (clearing) in solar lentigines as assessed by blinded physician reviewers using a VAS 4 point scale 0-3 where 0=no change and 3=Very much improved.

  12 weeks post- final treatment

Secondary Outcomes (4)

• Percent of Participants With Improvement Score >/=1

  12 weeks post- final treatment

• Percent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines

  12 weeks post- final treatment

• Mean Pain Score Associated With Laser Treatments

  During treatments

• Percent of Subjects With Post-treatment Adverse Event

  During study duration 0-6 months.

Study Arms (1)

Picosecond QS Nd:YAG Laser

EXPERIMENTAL

Laser Treatment with Investigational Device

Device: Picosecond QS Nd:YAG Laser

Interventions

Picosecond QS Nd:YAG Laser DEVICE

Up to 2 laser treatments delivered 6 weeks apart

Also known as: Cutera

Picosecond QS Nd:YAG Laser

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females or Males, 18 to 60 years of age (inclusive).
• Fitzpatrick Skin Type I - III (Appendix 2).
• Clinical diagnosis of benign solar lentigines of the hands.
• Presence of at least 5 lesions in the treatment area in diameters ranging from 1 to 8 mm.
• Has not used any prescription or over the counter topical creams (e.g., hydroquinone, and/or retinoids and/or corticosteroids) used in the treatment of pigmentation in the treatment area within the last 4 weeks.
• Willing to refrain from using any prescription or over the counter topical creams used for the treatment of pigmentation (e.g., hydroquinone, and/or retinoids and/or corticosteroids) in the treatment area during the study period.
• Must be able to read, understand and sign the Informed Consent Form.
• Willing and able to adhere to the treatment and follow-up schedule and before and after treatment care instructions.
• Willing to protect and/or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher in the treatment area starting up to 4 weeks before the treatment, every day for the duration of the study, including the follow-up period
• Willing to have digital photographs taken of the treatment area
• Agree not to undergo any other procedure(s) for the treatment of solar lentigines during the study.
• Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at last 3 months prior to enrollment and during the entire course of the study.

You may not qualify if:

• Participation in a study of another device of drug within 6 months prior to enrollment or during the study.
• Prior treatment of solar lentigines of the hands, e.g., with Q-Switched laser, IPL, Chemical peel, cryotherapy within 6 months of study participation.
• Having pre-malignant or malignant lesions (e.g., pigmented actinic keratosis, lentigo maligna \[12\], lentigo maligna melanoma), or history of a pre-malignant or malignant lesion in the treatment area.
• Subject shows signs of actinic bronzing or recent tanning in the treatment area, and unable/unlikely to refrain from tanning during the study.
• Skin abnormalities in the treatment area, e.g., cuts, scrapes, wounds, scars, large moles.
• Pregnant and/or breastfeeding.
• Having an infection, dermatitis or a rash in the treatment area.
• Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension
• Suffering from coagulation disorders or taking prescription anticoagulation medications.
• History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
• History of immunosuppression/immune deficiency disorders or currently using immunosuppression medications.
• History of vitiligo or psoriasis.
• History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
• History of seizure disorders due to light.
• Any use of medication that is known to increase sensitivity to light, such as tetracycline.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (1)

Cutera Research Center

Brisbane, California, 94005, United States

Location

Results Point of Contact

• Title: Clinical Research Department
• Organization: Cutera, Inc

gweiss@cutera.com

1-888-428-8372

Study Officials

• Lourdes Moldre, NP

  Cutera Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: June 21, 2013
• First Posted: June 25, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 27, 2018
• Results First Posted: October 12, 2015

Record last verified: 2015-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)