ScarsNCT04269317
Clinical Study to Evaluate the Safety and Effectiveness of the Treatment With Tixel C on Acne Scars
A study testing Tixel C in people with Scars, run by Novoxel Ltd. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Scars
- What is being tested?
- Tixel C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Mar 2020to 10 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Physicians Laser and Dermatology Institute
Chicago, Illinois, 60611
About this study
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
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.
Read the 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
- Being tested
- Tixel C
- Keywords
- Acne Scars, Post Acne, Scars
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tixel CDevice
Also called Fractional
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.
| Study group | Role | What they receive |
|---|---|---|
| Tixel C | Experimental | 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. Receives: Device: Tixel C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Adverse Events report
Safety of the investigational device shall be assessed via quantification of the incidence of devicerelated/non-related undesired effects, which shall be documented and reported as an Adverse Event (AE) or as a Serious Adverse Event (SAE). Known undesired effects may be any of the list stated in the previous paragraph of Expected Possible Side Effects, or any other undesired effect, not described in the said list. The incidence of the device related undesired effects should be analyzed considering severity, causal relation to the investigational device and duration, whether it is transient or permanent.
Measured: up to 12 months
Effectiveness using Goodman and Baron Assessment scale
Before starting therapy and at one and six months follow up visits, the subjects shall be photographed using clinical photography equipment. The images shall be evaluated by blinded raters. The evaluation shall be performed by three raters.
The scores shall be analyzed according to the statistical plan of the study. Scale between 1-4; 1 = Macular, 4= Severe
Measured: up to 12 months; Improvement between last follow up and baseline (before first treatment)
Secondary outcomes (1)
Performance using Goodman and Baron Assessment scale
Live Assessment by a study investigator - In each visit, an investigator or his designee shall examine by observing the subject and photographs will be taken as outlined. Scale between 1-4; 1 = Macular, 4= Severe
Measured: up to 12 months; Improvement between last follow up and baseline (before first treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion10 Jan 2021
- Study completion10 Jan 2021
Why it stopped: Delay in opening the study due to COVID-19, and following the sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novoxel Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerome M Garden, MD, Principal investigator, Physicians Laser and Dermatology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269317
- Sponsor's protocol ID
- CLN 0472
- Status last verified
- Jan 2021
- First submitted
- 6 Feb 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04269317
- Acronym / sponsor ID
- CLN 0472
- Conditions
- Scars
- Keywords
- Acne Scars, Post Acne, Scars
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Delay in opening the study due to COVID-19, and following the sponsor's decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novoxel Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 10 Jan 2021 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tixel C | Experimental | Device: Tixel CTixel 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tixel CAlso: FractionalThermo-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. | Device | Tixel C |
Primary outcome
Safety Adverse Events report
Time frame: up to 12 months
Safety of the investigational device shall be assessed via quantification of the incidence of devicerelated/non-related undesired effects, which shall be documented and reported as an Adverse Event (AE) or as a Serious Adverse Event (SAE). Known undesired effects may be any of the list stated in the previous paragraph of Expected Possible Side Effects, or any other undesired effect, not described in the said list. The incidence of the device related undesired effects should be analyzed considering severity, causal relation to the investigational device and duration, whether it is transient or permanent.
Effectiveness using Goodman and Baron Assessment scale
Time frame: up to 12 months; Improvement between last follow up and baseline (before first treatment)
Before starting therapy and at one and six months follow up visits, the subjects shall be photographed using clinical photography equipment. The images shall be evaluated by blinded raters. The evaluation shall be performed by three raters. The scores shall be analyzed according to the statistical plan of the study. Scale between 1-4; 1 = Macular, 4= Severe
1 secondary outcome
Performance using Goodman and Baron Assessment scale
Time frame: up to 12 months; Improvement between last follow up and baseline (before first treatment)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerome M Garden, MD principal investigator
Physicians Laser and Dermatology Institute
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tixel C in people with Scars, run by Novoxel Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Adverse Events report (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.