Phase
Condition
Keratoses
Treatment
Tixel C
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female, age 18-80 years old.
Skin Phototype I-VI.
Subject has mild to moderate thickness confluent AKs on his/her scalp and/or face.
Subject is willing and able to comply with protocol requirements and all studyvisits.
Subject has provided written informed consent.
Exclusion
Exclusion Criteria:
Any patient who has undergone tanning during the 4 weeks prior to any treatmentsession and/or any patient who plans to undergo tanning during the 4 weeks followingany treatment session (patients who may be exposed to the sun for short periods oftime occasionally are not contra-indicated as long as they apply a high SPFsunscreen (>50).
Current active Herpes Simplex infection.
Current skin cancer, malignant sites and/or advanced premalignant lesions or molesin the treatment area.
An impaired immune system condition or use of immunosuppressive medication.
Collagen disorders, keloid formation and/or abnormal wound healing.
Any patient who takes or has taken any medications (including via topicalapplication), herbal treatment (oral or topic), food supplements or vitamins, whichmay cause fragile skin or impaired skin healing during the last 3 months.
Any patient who has used oral retinoids within 6 months prior to treatment or less.
Any patient who has a history of bleeding coagulopathies.
Any patient who has tattoos or permanent makeup in the treated area.
Any patient who has burned skin, blistered skin, irritated skin, or sensitive skinin any of the areas to be treated.
Women who are pregnant (as determined by self-reporting), lactating, or less than 3months post-delivery, possibly pregnant or planning a pregnancy during the studyperiod.
Currently participating in or recently participated in another clinical trial (within the last 30 days).
Prior treatment with ablative laser, any laser or photo-dynamic therapy 3 monthsprior to enrollment.
Any cryotherapy or electrodessication 6 weeks prior to enrollment.
Systemic retinoid therapy within 6 months prior to enrollment, topical treatmentwith 5-Fluorouracil cream and/or imiquimod cream and/or diclofenac gel 6 monthsprior to enrollment.
Prior treatment with Tixel.
Face cannot be treated due to dermal disorder other than AKs, such as infection,surgical treatment etc.
Subject has a systemic disease manifested by AKs (e.g. immune suppression).
Significant systemic illness.
Study Design
Study Description
Connect with a study center
Rabin Medical Center, Ha'Sharon Campus
Petach Tikva, 49100
IsraelSite Not Available
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