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

Withdrawn before enrolling · Not applicable

Conditions studied: Scars

In brief

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.

Key facts

Study ID

NCT04269317

Run by

Novoxel Ltd.

People needed

0

Starts

2020-03-01

Expected to finish

2021-01-10

Last updated by the study team

2021-01-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.
• 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.
• 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.
• History of any disease that inhibits pain sensation.
• History of Diabetes I or II.
• Concurrent therapy that, in the principal investigator's opinion, would interfere with the evaluation of the safety or effectiveness of the study treatment.
• Subjects who, in the Investigator's opinion, have a history of poor cooperation, non-compliance with medical treatment or unreliability.
• 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.
• Any other contraindication stated in the guidance documents of the treatment device.
• 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.
• Hypertrophic facial acne scarring or other hypertrophic scarring.
• Failure to acquire adequate baseline and final photography.

Where it is running

• Physicians Laser and Dermatology Institute — Chicago, Illinois, United States
• The Lehavit Akerman Main Clinic — Herzliya, Israel

Full record on ClinicalTrials.gov

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