Clinical Study to Evaluate the Safety and Effectiveness of the Treatment With Tixel C on Acne Scars

NCT04269317 | Withdrawn FDA Device

• 1 other identifier: CLN 0472
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this research is to evaluate the safety and effectiveness of the Tixel C device for the treatment of acne scars, for improvement in the appearance of surface texture.

Conditions

Scars

Keywords

Acne Scars; Post Acne; Scars

Outcome Measures

Primary Outcomes (2)

• Safety Adverse Events report

  Safety of the investigational device shall be assessed via quantification of the incidence of devicerelated/non-related undesired effects, which shall be documented and reported as an Adverse Event (AE) or as a Serious Adverse Event (SAE). Known undesired effects may be any of the list stated in the previous paragraph of Expected Possible Side Effects, or any other undesired effect, not described in the said list. The incidence of the device related undesired effects should be analyzed considering severity, causal relation to the investigational device and duration, whether it is transient or permanent.

  up to 12 months

• Effectiveness using Goodman and Baron Assessment scale

  Before starting therapy and at one and six months follow up visits, the subjects shall be photographed using clinical photography equipment. The images shall be evaluated by blinded raters. The evaluation shall be performed by three raters. The scores shall be analyzed according to the statistical plan of the study. Scale between 1-4; 1 = Macular, 4= Severe

  up to 12 months; Improvement between last follow up and baseline (before first treatment)

Secondary Outcomes (1)

• Performance using Goodman and Baron Assessment scale

  up to 12 months; Improvement between last follow up and baseline (before first treatment)

Study Arms (1)

Tixel C

EXPERIMENTAL

Tixel Treatment, between 3-5 treatment session according to investigator's review of subject response follow by 3 Follow up sessions, 1,3 and 6 month after last treatment visit. Subject would be questioned about pain levvel, subjective dountime assessment and subjective response assessment. Images would be taken before treatment visit and in Follow-Up.

Device: Tixel C

Interventions

Tixel C DEVICE

Thermo-mechanical technology for fractional treatment of human skin. Dermal heating and coagulative effect that occur during the treatment session provide for dermal remodeling and collagen restructuring that promote acne scar appearance improvement.

Also known as: Fractional

Tixel C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The Subjects will have atrophic mild to severe acne scars.
• Male or female subjects, age 18-65 years old.
• The subjects will have Fitzpatrick Skin Types I-VI.
• Willingness and ability to provide written informed consent, including photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup), prior to the study.
• Females post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).

You may not qualify if:

• Subjects pregnant or planning to become pregnant, or have given birth less than three months ago or breast feeding.
• Subjects with significant exposure to ultraviolet light.
• Use of drugs that may induce hyperpigmentation such as amiodarone, clofazinmine, minocycline or chloroquine.
• History of facial acne scar treatments with laser, surgical, chemical, light based or radiofrequency facial treatments.
• Microdermabrasion, or prescription level glycolic acid treatments within three months prior to study participation.
• Active HSV-1. May be enrolled only after a prophylactic regime has been followed prior to treatment and according to the Investigator's discretion.
• History of keloid formation.
• Permanent facial implant over area of treatment.
• Injectable filler in area to be treated within nine months of investigation.
• History of collagen vascular disease.
• Subjects who have an impaired immune system, suffer from immunosuppressive diseases or are actively on immunosuppressive medications.
• Subjects currently taking or have taken an oral retinoid in the past six months.
• Subjects currently taking long-term oral steroid treatment
• Subjects with any skin pathology which can induce bullous lesions, urticaria, or demonstrate a Koebner phenomenon (psoriasis, lichen planus, etc.).
• History of autoimmune disease.

Sponsors & Collaborators

• Novoxel Ltd.: lead

Study Sites (2)

Physicians Laser and Dermatology Institute

Chicago, Illinois, 60611, United States

Location

The Lehavit Akerman Main Clinic

Herzliya, 4672553, Israel

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jerome M Garden, MD

  Physicians Laser and Dermatology Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blinded assessed of the improvement would be done between Last FU images and before first treatment after randomization of the images.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 13, 2020
• Study Start: March 1, 2020
• Primary Completion: January 10, 2021
• Study Completion: January 10, 2021
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

US (1); IL (1)