Pilot Evaluation of Thulium Laser Alone or in Combination With Broad Band Light for Treatment of Dermatologic Conditions

October 19, 2020 updated by: Sciton
Evaluate the Thulium laser device for skin resurfacing procedures, or as a treatment for pigmented lesions (age or sun spots) or dyschromia; or cutaneous lesions such as, but not limited to, actinic keratosis, melasma, fine rhytides; or as a method of improving skin tone and skin texture

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Gatos, California, United States, 95032
        • Refined Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Female or Male, 18 years and older
  2. Fitzpatrick Skin Type I-VI
  3. Subject has visible signs of moderate sun-damages and/or aging facial skin with visible areas of fine rhytides, pigmentation, and erythema or telangiectasia.
  4. Desires non-ablative photo-revitalization of the skin.
  5. Subject must agree to not make any changes in their skin regimen for the duration of the study, including the follow-up period.
  6. Subject must be able to read, understand and sign the Informed Consent Form.
  7. Must be willing and able to adhere to the treatment and follow-up schedule and post- treatment care instructions.
  8. 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.
  9. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
  10. Agree to not undergo any other procedure(s) in the treatment area during the study, such as laser- or light-based treatment, non-light based device treatment such as radiofrequency or ultrasound, injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler, chemical peel, or surgical procedure

Exclusion Criteria:

  1. Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
  2. Any type of prior cosmetic treatment to the target area within 3 months of study participation, such as laser or light-based procedures or surgery.
  3. Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler in the target area within 1 week of study participation.
  4. History of malignant tumors in the target area.
  5. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
  6. Pregnant and/or breastfeeding.
  7. Having an infection, dermatitis or a rash in the treatment area.
  8. Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
  9. Suffering from coagulation disorders or taking prescription anticoagulation medications.
  10. History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
  11. History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
  12. History of vitiligo, eczema, or psoriasis.
  13. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
  14. History of seizure disorders due to light.
  15. Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
  16. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
  17. History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
  18. History of pigmentary disorders, particularly tendency for hyper- or hypo- pigmentation.
  19. Systemic use of retinoid, such as isotretinoin, or corticosteroid, as applicable, within 6 months of study participation.
  20. Topical use of retinoid, such as isotretinoin, corticosteroid or hydroquinone on the target area within 1 month of participation.
  21. Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
  22. Excessively tanned in areas to be treated, or unable/unlikely to refrain from tanning during the study (for example, subject's occupation requires regular sun exposure).
  23. Current smoker or history of smoking within 6 months of study participation.
  24. Has infectious disease
  25. Has been on long-standing systemic steroids (e.g. Prednisone, Dexamethasone)
  26. Has medical condition that may affect wound healing
  27. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Thulium Device
1927 Laser Treatment
Device: Thulium Laser
Thulium laser for skin resurfacing procedures

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Photography
Time Frame: 6 weeks post final treatment
Change in photography when compared to baseline using Physicians global assessement scale
6 weeks post final treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain scores
Time Frame: Immediately after each treatment received
Pain during treatment scored using Numeric pain scale 0-10, where 0 is least pain and 10 being maximum pain
Immediately after each treatment received

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sciton

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jay Patel, Sciton

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S-18-TB01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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