Efficacy and Safety of Tixel Treatment on Facial and/or Scalp Actinic Keratoses.

NCT05365386 | Completed Results

• 1 other identifier: CLN 0827
• 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

Keywords

actinic keratoses.

Outcome Measures

Primary Outcomes (1)

• Efficacy of Tixel for Treatment of Actinic Keratosis

  The overall mean percentage reduction in actinic keratoses lesion count performed by the investigator manually, confirmed and documented using photograph images taken at baseline and at 12 weeks follow-up visit (or 12-weeks post last treatment if less than 3 treatments were done) (before and after marking the present actinic keratoses using a washable eyeliner) calculated as the relative change from baseline at 12 weeks. New lesions which were not existed in baseline will not be counted.

  up to 12 weeks post last treatment

Secondary Outcomes (7)

• Efficacy Evaluation of Tixel for Treatment of Actinic Keratosis

  up to 12 weeks post last treatment

• Efficacy Evaluation of Tixel for Treatment of Actinic Keratosis

  up to 4 weeks post last treatment

• Efficacy of Tixel for Treatment of Actinic Keratosis - Percentage of Subjects That Demonstrated Reduction in Actinic Keratosis Lesion Count 3 Months After the Last Treatment.

  up to 12 weeks post last treatment

• To Evaluate the Subject's Satisfaction.

  up to 12 weeks post last treatment

• Safety Evaluation - Adverse Events

  up to 12 weeks post last treatment

Study Arms (1)

Tixel Treatment

EXPERIMENTAL

All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device.

Device: Tixel C

Interventions

Tixel C DEVICE

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

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:

• 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 study visits.
• Subject has provided 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 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 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).
• Prior treatment with ablative laser, any laser or photo-dynamic therapy 3 months prior to enrollment.
• Any cryotherapy or electrodessication 6 weeks prior to enrollment.
• Systemic retinoid therapy within 6 months prior to enrollment, topical treatment with 5-Fluorouracil cream and/or imiquimod cream and/or diclofenac gel 6 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

Results Point of Contact

• Title: Dr. Ifat Klein
• Organization: Novoxel Ltd

ifat@novoxel.com

+972.52-6009860

Study Officials

• Assi Levi, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• 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: March 23, 2022
• First Posted: May 9, 2022
• Study Start: May 17, 2022
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: December 3, 2024
• Results First Posted: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)