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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)