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

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: Completed
• Conditions: Dermatology/Skin - Other
• Intervention / Treatment: Device: Thulium Laser

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thulium Device; 1927 Laser Treatment	Device: Thulium Laser; Thulium laser for skin resurfacing procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Photography	Change in photography when compared to baseline using Physicians global assessement scale	6 weeks post final treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	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

• Sponsor: Sciton
• Investigators: Study Director: Jay Patel, Sciton

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2019
• Primary Completion (Actual): August 30, 2020
• Study Completion (Actual): September 29, 2020

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID 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