Clinical Study to Evaluate the Safety and Effectiveness of the Treatment With Tixel C on Acne Scars (NCT04269317) | Clinical Trial Compass
WithdrawnNot Applicable
Clinical Study to Evaluate the Safety and Effectiveness of the Treatment With Tixel C on Acne Scars
Stopped: Delay in opening the study due to COVID-19, and following the sponsor's decision
United States, Israel0Started 2020-03-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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).
✕. 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.
What they're measuring
1
Safety Adverse Events report
Timeframe: up to 12 months
2
Effectiveness using Goodman and Baron Assessment scale
Timeframe: up to 12 months; Improvement between last follow up and baseline (before first treatment)