Clinical trial NCT02763072: A Single-Center 2-Arm Study for Lentigines on the Hands
Official title: A Single-Center 2-Arm Study of the Enlighten and Excel V Laser for Lentigines on the Hands
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lentigines
Lead sponsor: Cutera Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-05
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of two laser systems for improvement of lentigines on the hands.

Detailed description: The purpose of this study is to evaluate the effectiveness and safety in a clinic setting of two laser systems for the treatment of lentigines (liver spots, age spots, or dark sun spots) on the hands.

Eligibility criteria: Inclusion Criteria:

1. Female or Male, 30-90 years of age (inclusive).
2. Fitzpatrick Skin Type I - III.
3. Desires non-invasive and non-ablative treatment of lentigines on the hand(s).
4. Have 4 or more lentigines on the hand(s).
5. Subject must be able to read, understand and sign the Informed Consent Form.
6. Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
7. Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treatment area every day for the duration of the study, including the follow-up period.
8. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
9. Agree to not undergo any other procedure(s) for treatment of lentigines during the study, including but not limited to chemical peel, laser and light based device treatment, and home-use device treatment.
10. Agree to not undergo any injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler to the treatment area during the study.

Exclusion Criteria:

1. Participation in a clinical trial of another device or drug in the target area within 6 months prior to enrollment or during the study.
2. Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser or light-based procedures or surgery.
3. Systemic use of retinoid, such as isotretinoin, within 6 months of study participation.
4. Use of topical medications on the hands, such as antibiotics, benzoyl peroxide, retinoids (isotretinoin), corticosteroids, hydroquinone, or products containing dihydroxyacetone or alpha-hydroxy with concentration \> 8%, within 1 month of participation.
5. History of malignant tumors in the target area.
6. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
7. Pregnant.
8. Having an infection, dermatitis, or a rash in the treatment area.
9. History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
10. Any use of medication that is known to increase sensitivity to light according to investigator's discretion.
11. History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
12. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
13. Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
14. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
15. In the opinion of the investigator, any physical or mental condition which might make it unsafe for the subject to participate in this study or which requires systematic therapy that could interfere with this research study.

Primary outcomes:
measure: Percent Reduction in the Number of Hand Lentigines as Assessed by Blinded Reviewers.
timeFrame: 4 weeks post-final treatment
Secondary outcomes:
measure: Physician's Global Assessment Score of the Overall Appearance of the Hands
timeFrame: 4 weeks post final treatment
measure: Physician's Global Assessment Score of Skin Texture of the Hands
timeFrame: 4 weeks post final treatment
measure: Subject Satisfaction
timeFrame: 4 weeks post final treatment
Other outcomes:
Locations:
city: Naperville
country: United States
facility: DuPage Medical Group
state: Illinois
Study officials:
affiliation: DuPage Medical Group
name: Kelly Stankiewicz, MD FAAD
role: PRINCIPAL_INVESTIGATOR
References: