Clinical trial NCT04269317: Clinical Study to Evaluate the Safety and Effectiveness of the Treatment With Tixel C on Acne Scars
Official title: A Prospective Study With Blinded Assessment to Evaluate the Safety and Effectiveness of the Tixel C Fractional System in the Treatment of Acne Scars
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Scars
Keywords: Acne Scars
Post Acne
Scars
Lead sponsor: Novoxel Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Safety Adverse Events report
timeFrame: up to 12 months
measure: Effectiveness using Goodman and Baron Assessment scale
timeFrame: up to 12 months; Improvement between last follow up and baseline (before first treatment)
Secondary outcomes:
measure: Performance using Goodman and Baron Assessment scale
timeFrame: up to 12 months; Improvement between last follow up and baseline (before first treatment)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Physicians Laser and Dermatology Institute
state: Illinois
city: Herzliya
country: Israel
facility: The Lehavit Akerman Main Clinic
Study officials:
affiliation: Physicians Laser and Dermatology Institute
name: Jerome M Garden, MD
role: PRINCIPAL_INVESTIGATOR
References: