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

NCT ID: NCT04269317

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-01-10

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.

Detailed Description

44 participents between two research locations with moderate acne scars will receive 3-5 treatments sessions with the Tixel C device according to investigator's review of subject response. Improvement of acne scarring will ve evaluated at 1 month, 3 months and 6 months post treatment.

Post-treatment response will be evaluated as well as any incidence of side efects throughout the study.

Conditions

Scars

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tixel C

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.

Group Type: EXPERIMENTAL

Tixel C

Intervention Type: 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.

Interventions

Tixel C

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.

Intervention Type: DEVICE

Other Intervention Names

Fractional

Eligibility Criteria

Inclusion Criteria

1. The Subjects will have atrophic mild to severe acne scars.

2. Male or female subjects, age 18-65 years old.

3. The subjects will have Fitzpatrick Skin Types I-VI.

4. 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.

5. Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.

6. 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).

Exclusion Criteria

1. Subjects pregnant or planning to become pregnant, or have given birth less than three months ago or breast feeding.

2. Subjects with significant exposure to ultraviolet light.

3. Use of drugs that may induce hyperpigmentation such as amiodarone, clofazinmine, minocycline or chloroquine.

4. History of facial acne scar treatments with laser, surgical, chemical, light based or radiofrequency facial treatments.

5. Microdermabrasion, or prescription level glycolic acid treatments within three months prior to study participation.

6. Active HSV-1. May be enrolled only after a prophylactic regime has been followed prior to treatment and according to the Investigator's discretion.

7. History of keloid formation.

8. Permanent facial implant over area of treatment.

9. Injectable filler in area to be treated within nine months of investigation.

10. History of collagen vascular disease.

11. Subjects who have an impaired immune system, suffer from immunosuppressive diseases or are actively on immunosuppressive medications.

12. Subjects currently taking or have taken an oral retinoid in the past six months.

13. Subjects currently taking long-term oral steroid treatment

14. Subjects with any skin pathology which can induce bullous lesions, urticaria, or demonstrate a Koebner phenomenon (psoriasis, lichen planus, etc.).

15. History of autoimmune disease.

16. History of any disease that inhibits pain sensation.

17. History of Diabetes I or II.

18. Concurrent therapy that, in the principal investigator's opinion, would interfere with the evaluation of the safety or effectiveness of the study treatment.

19. Subjects who, in the Investigator's opinion, have a history of poor cooperation, non-compliance with medical treatment or unreliability.

20. Enrollment in any active study involving the use of investigational devices or drugs who in the Investigator's opinion would interfere with the evaluation of the current investigative device.

21. Any other contraindication stated in the guidance documents of the treatment device.

22. Any existing skin disease that in the investigator's opinion would interfere with the evaluation of the safety of the study treatment and any other cause per the principal investigator's discretion.

23. Hypertrophic facial acne scarring or other hypertrophic scarring.

24. Failure to acquire adequate baseline and final photography.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novoxel Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerome M Garden, MD

Role: PRINCIPAL_INVESTIGATOR

Physicians Laser and Dermatology Institute

Locations

Physicians Laser and Dermatology Institute

Chicago, Illinois, United States

The Lehavit Akerman Main Clinic

Herzliya, , Israel

Countries

United States; Israel

Other Identifiers

CLN 0472

Identifier Type: -

Identifier Source: org_study_id