Evaluation of The Efficacy and Safety of Tixel Treatment for the Treatment of Facial and/or Scalp Actinic Keratoses

NCT04527653 | Completed

• 1 other identifier: CLN 0732
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the Efficacy and Safety of a thermal fractional skin treatment system (Tixel) for the treatment of facial and/or scalp actinic keratoses

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (2)

• Blinded Evaluation of Improvement

  lesions count as well as an evaluation of the overall improvement in facial appearance based on a quartile scale of improvement graded as 0 (exacerbation) 1 (1-25% improvement), 2 (26-50% improvement), 3 (51-75% improvement) or 4 (76-100% improvement)\]

  6 months

• Safety, number of Adverse Events

  Any safety related event during the study will be record and analysed

  6 months

Secondary Outcomes (4)

• Subject Satisfaction Assessments

  6 months

• Downtime Assessment

  4 moths

• Discomfort Assessment

  3 months

• Expected immediate response

  3 months

Study Arms (1)

Tixel Treatment

EXPERIMENTAL

This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology

Device: Tixel

Interventions

Tixel DEVICE

Non-invasive thermo-mechanical treatment

Tixel Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80
• Skin Photo type I-VI
• Mild to moderate thickness confluent actinic keratoses located to scalp and/or face
• Subject is willing and able to comply with protocol requirements and all study visits
• Subject has provided a written informed consent

You may not qualify if:

• Any patient who has undergone tanning during the 4 weeks prior to any treatment session and/or any patient who plans to undergo tanning during the 4 weeks following any treatment session (patients who may be exposed to the sun for short periods of time occasionally are not contra-indicated as long as they apply a high SPF sunscreen (\>50).
• Current active Herpes Simplex infection.
• Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in 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 topical application), herbal treatment (oral or topic), food supplements or vitamins, which may cause fragile skin or impaired skin healing during the last 3 months.
• Any patient who has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 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 skin in any of the areas to be treated.
• Women who are pregnant (as determined by self-reporting), lactating, or less than 3 months post-delivery, possibly pregnant or planning a pregnancy during the study period.
• Currently participating in or recently participated in another clinical trial (within the last 30 days).
• Age below 18 years.
• Subject underwent prior treatments for actinic keratoses including:
• Prior treatment with ablative laser, any laser or photo-dynamic therapy 3 months prior to enrollment.

Sponsors & Collaborators

• Novoxel Ltd.: lead

Study Sites (1)

Rabin Medical Center, Ha'Sharon Campus

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Assi Levi, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The mean of the improvement in actinic keratosis performed by two independent dermatologists using photograph images taken at baseline and at 4, 12-weeks follow-up visits.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-center, Prospective, Open Label, with Before-After Study Design

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 26, 2020
• Study Start: May 14, 2020
• Primary Completion: April 19, 2021
• Study Completion: April 19, 2021
• Last Updated: June 4, 2021

Record last verified: 2021-06

Locations

IL (1)