Laser Removal of Age (Sun) Spots on Hands

Solar Lentigines Clinical Trial

Official title:

Safety and Efficacy of Cutera Picosecond Q-Switched Nd:YAG Laser in the Treatment of Solar Lentigines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885871
• Other study ID #: C-13-LPS03
• Secondary ID: C-13-LPS03
• Status: Completed
• Phase: N/A
• First received: June 21, 2013
• Last updated: January 30, 2018
• Start date: June 2013
• Est. completion date: August 2014

Study information

• Verified date: October 2015
• Source: Cutera Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The purpose of this study is to evaluate the safety and efficacy of Cutera Picosecond Q-Switched Nd:YAG 1064 and/or 532 nm laser in the treatment of benign pigmented lesions on the hands.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.

• History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.

• Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.

• Current smoker or history of smoking within 2 years of study participation.

• As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

• History of allergy to topical antibiotics.

Related Conditions & MeSH terms

• Lentigo
• Solar Lentigines

Intervention

Device:
• Picosecond QS Nd:YAG Laser
Up to 2 laser treatments delivered 6 weeks apart

Locations

Country	Name	City	State
United States	Cutera Research Center	Brisbane	California

Sponsors (1)

Lead Sponsor	Collaborator
Cutera Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent of Participants With Improvement Score >/=1	Improvement (clearing) in solar lentigines as assessed by participant using a 4-point VAS 0-3 scale where 0=no change and 3=very much improved. Scores >/=1 indicate improvement.	12 weeks post- final treatment
Secondary	Percent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines	Level of Satisfaction with Improvement (clearing) in solar lentigines as assessed by participants, as measured by spot Improvement: 3=Very Much Improved, 2=Much Improved, 1=Improved, and 0=No Change.	12 weeks post- final treatment
Secondary	Mean Pain Score Associated With Laser Treatments	Subjects graded the level of pain associated with each laser treatment, using a 0-10 scale where 0=no pain and 10=worse possible pain, then averaged to get the mean across the treatments.	During treatments
Secondary	Percent of Subjects With Post-treatment Adverse Event		During study duration 0-6 months.