An interventional study of Excel V™ Laser & Micro-Lens Array Attach in Scarring and Skin Aging, sponsored by Cutera Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-14.
Sponsored by Cutera Inc. · Not applicable, Interventional, and Other
Among 198 studies in Cicatrix with a site in United States — 24 open to participants now, 34 under way, 2 of them phase 3. Cicatrix · United States.
Among the 198 studies in Cicatrix with a site in United States, this one is the 143rd largest by enrollment of the 184 interventional ones that give a count, is one of 9 that started in 2018, is one of 130 with no phase, and was the 119th registered.
612 studies on the registry are indexed under Cicatrix; 115 are open to participants now.
Browse Cicatrix studies →24 of the 198 studies in Cicatrix with a site in United States are open now. Recruiting first, the newest first:
Montefiore Medical Center · Sites in United States
Ages 18+ · Women only
AbbVie · Sites in United States
Ages 22+
University of California, Davis · Sites in United States
Ages 18+
Columbia University · Sites in United States
Ages 18+
Medstar Health Research Institute · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 69 Cicatrix studies recruiting now, 34 (49%) set no upper age limit and 31 (45%) stop at 75 or younger; 11 take children under 18; 16 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
198 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 20 · Phase 2 34 · Phase 3 6 · Phase 4 5
First in 1995; this study’s year is marked. 9 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 10 is below the median of 40 across 513 interventional studies indexed under Cicatrix.
Median enrollment 25 across the 184 interventional studies, 101 across the 13 observational. Of the 131 that completed or were terminated, 56 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
76 of 198 have an industry lead sponsor. The 10 most frequent:
Cutera Inc. is the lead sponsor of 42 studies on the registry; none are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 19 (100%) have results posted.
Cutera Inc. has 5 studies filed under Cicatrix — fewer than ten, so there is no comparison to draw.
9 of the studies in Cicatrix with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05478551Phase 3Henry Ford Health SystemRandomized Controlled Trial Examining the Efficacy of Botulinum Toxin in Biopsy Scar Minimization | 2026-12-30 |
| NCT05758181University of California, DavisUndermining Apices in Surgical Wounds | 2026-12-31 |
| NCT06448481University of California, DavisAesthetic Outcome of Intra-dermal Versus Transcutaneous Purse-string Closure | 2027-01-01 |
| NCT06171386Wake Forest University Health SciencesMicroneedling vs Dermabrasion for Early Facial Scar Resurfacing | 2027-04 |
| NCT06903208Columbia UniversityRFA for Superficial Lipomas | 2027-07 |
Add all 9 to your calendar (.ics) → With an account.
Among the 198 studies in Cicatrix with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Open-label, Prospective, Study to Evaluate the Cutera excel V laser at 532 nm in a low fluence, high repetition rate mode and the Micro-Lens Array attachment used with excel V laser at 1064 nm and 532 nm for the improvement of skin quality.
This is an open-label, prospective, study in approximately 60 male or female subjects, age 18 to 65 years who desire laser treatment for the improvement of rhytides, lentigines, pigmentation, erythema, telangiectasia, pore size and skin texture. Subjects may undergo a 2mm punch biopsy a treatment area up to 72 hours post treatment and at a designated follow-up period per Investigator discretion. Subjects will receive laser treatments. Subjects will return to the site after final study treatment for two follow-up visits: 6 and 12 weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with Excel V™ Laser and a Micro-Lens Array Attachment for skin quality
Device: Excel V™ Laser & Micro-Lens Array Attach
Subjects will receive laser treatments
Study Effectiveness for Skin Aesthetic Improvement
Efficacy of treatment(s) with Cutera excel V™ laser and the Micro-Lens Array attachment as assessed by the study investigator using GAIS: Global Aesthetic Improvement Scale Higher scores indicate better outcomes (+4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, or 0=No Change) Subjects had one assessment done at either the 6 or 12 week follow up, and GAIS values from the 6 and 12 week follow up visits were summed together to calculate the mean
Time frame: 6 or 12 weeks after the final treatment
| Milestone | Excel V™ Laser & Micro-Lens Array Attachment |
|---|---|
| Started | 10 |
| Completed | 8 |
| Not completed | 2 |
Efficacy of treatment(s) with Cutera excel V™ laser and the Micro-Lens Array attachment as assessed by the study investigator using GAIS: Global Aesthetic Improvement Scale Higher scores indicate better outcomes (+4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, or 0=No Change) Subjects had one assessment done at either the 6 or 12 week follow up, and GAIS values from the 6 and 12 week follow up visits were summed together to calculate the mean
| score on a scale | Excel V™ Laser & Micro-Lens Array Attachment |
|---|---|
| Study Effectiveness for Skin Aesthetic Improvement | 1.25 ± 0.71 |
Collected over 12 weeks post final treatment, up to 9 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Excel V™ Laser & Micro-Lens Array Attachment | 0/10 (0%) | 0/10 (0%) | 10/10 (100%) |
| Event | Excel V™ Laser & Micro-Lens Array Attachment |
|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 10/10 |
| EdemaSkin and subcutaneous tissue disorders | 9/10 |
| PurpuraSkin and subcutaneous tissue disorders | 1/10 |
| Age, Continuous(years) | Excel V™ Laser & Micro-Lens Array Attachment |
|---|---|
| Mean | 53.1 ± 15.4 |
| Sex: Female, Male(Participants) | Excel V™ Laser & Micro-Lens Array Attachment |
|---|---|
| Female | 9 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | Excel V™ Laser & Micro-Lens Array Attachment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Nov 2018, 9 months.
Results were first posted in Sep 2023, 4 years 9 months after primary completion.
Of 33 industry-sponsored interventional studies with no phase under Cicatrix, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 20. This study's 9 months is close to that.
Counting every sponsor, half of 206 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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