Skintel Integration Study

Skintel Integration Study for Use With the Elite+ Laser System

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02130609

Enrollment

Registered

2014-05-05

Start date

2013-12-31

Completion date

2016-09-30

Last updated

2020-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Type From I-VI on Non-hair Bearing Skin

Brief summary

The objective of this study is to improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index (MI) (MI).

Interventions

DEVICESkintel

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Intervention model description

Even though this study has recruited more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial. The objective of this study is to improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index (MI).

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years and older * Able to read, understand, and sign the Informed Consent Form * Willing and able to comply with all study requirements

Exclusion criteria

* Hypersensitivity to light in the near infrared wavelength region * Sun-damaged skin (treatment contraindicated with Alex laser only) * Unprotected sun exposure (for Alex laser within four weeks of treatment; for * Nd:YAG laser within one week of treatment), including the use of tanning beds or * tanning products, such as creams, lotions and sprays * Take medication which is known to increase sensitivity to sunlight * Seizure disorders triggered by light * Take anticoagulants * Take or have taken oral isotretinoin, such as Accutane®, within the last six months * Take medication that alters the wound-healing response * History of healing problems or history of keloid formation * Active localized or systemic infection, or an open wound in area being treated * Significant systemic illness or an illness localized in area being treated * History of skin cancer or suspicious lesions * Lupus * Have received or are receiving or gold therapy * Pregnancy, planning on becoming pregnant or have been pregnant recently

Design outcomes

Primary

Measure	Time frame
improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index	9 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026