Clinical trial: Pilot Evaluation of Thulium Laser Alone or in Combination With Broad Band Light for Treatment of Dermatologic Conditions (NCT03944278)

Eligibility 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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? Contradiction