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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03944278
Recruitment Status : Completed
First Posted : May 9, 2019
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Sciton

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Dermatology/Skin - Other Device: Thulium Laser Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Evaluation of Thulium Laser Alone or in Combination With Broad Band Light for Treatment of Dermatologic Conditions
Actual Study Start Date : April 12, 2019
Actual Primary Completion Date : August 30, 2020
Actual Study Completion Date : September 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions
Drug Information available for: Thulium

Arms and Interventions
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Arm Intervention/treatment
Experimental: Thulium Device
1927 Laser Treatment
 Device: Thulium Laser
Thulium laser for skin resurfacing procedures


Outcome Measures
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Primary Outcome Measures :
  1. Photography [ Time Frame: 6 weeks post final treatment ]
    Change in photography when compared to baseline using Physicians global assessement scale


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944278


Locations
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United States, California
Refined Dermatology
Los Gatos, California, United States, 95032
Sponsors and Collaborators
Sciton
Investigators
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Study Director: Jay Patel Sciton
More Information
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Responsible Party: Sciton
ClinicalTrials.gov Identifier: NCT03944278    
Other Study ID Numbers: S-18-TB01
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Skin Diseases