An interventional study of other in Acne Scars - Mixed Atrophic and Hypertrophic, 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 2023-08-01.
Sponsored by Cutera Inc. · Not applicable, Interventional, and Other
Among 47 studies in Hypertrophy with a site in United States — 8 open to participants now, 9 under way, none of them phase 3. Hypertrophy · United States.
Among the 47 studies in Hypertrophy with a site in United States, this one is the 15th largest by enrollment of the 41 interventional ones that give a count, is one of 3 that started in 2017, is one of 34 with no phase, and was the 17th registered.
140 studies on the registry are indexed under Hypertrophy; 23 are open to participants now.
Browse Hypertrophy studies →8 of the 47 studies in Hypertrophy with a site in United States are open now. Recruiting first, the newest first:
Atrium Therapeutics · Sites in United States
Ages 18–65
University of Wisconsin, Madison · Sites in United States
Ages 18–25 · Healthy volunteers
AVAVA, Inc. · Sites in United States
Ages 18–70 · Healthy volunteers
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Sites in United States
Ages 20–89 · Women only
Montefiore Medical Center · Sites in United States
Ages 18+ · Healthy volunteers
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 13 Hypertrophy studies recruiting now, 3 (23%) set no upper age limit and 7 (54%) stop at 75 or younger; none take children under 18; 9 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.
47 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 4 · Phase 2 2 · Phase 3 1 · Phase 4 2
First in 1995; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 45 is above the median of 34 across 113 interventional studies indexed under Hypertrophy.
Median enrollment 30 across the 41 interventional studies, 191 across the 6 observational. Of the 36 that completed or were terminated, 14 (39%) have results posted.
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17 of 47 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 1 study filed under Hypertrophy — fewer than ten, so there is no comparison to draw.
3 of the studies in Hypertrophy with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05898074Indiana UniversityRole of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery | 2026-12-15 |
| NCT06115486Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)EXERT-BCH Exercise Regimen to Improve Muscle Mass After Treatment of Breast Cancer | 2027-01 |
| NCT07716319University of Wisconsin, MadisonComparison Between Eccentric Hamstring Training and Sprint-Specific Training | 2027-09 |
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Among the 47 studies in Hypertrophy with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this pivotal investigation is to evaluate the efficacy and safety of the Cutera enlighten multi-wavelength 532 nm and 1064 nm Nd:YAG picosecond pulse duration laser and an investigational micro-lens array (MLA) handpiece attachment for improvement of acne scars.
This is an open-label, prospective, multicenter, pivotal study in up to 45 male or female subjects, age 18 to 65 years who desire laser treatment for the improvement of acne scars. Subjects will receive up to 6 laser treatments, spaced 6 weeks (± 2 weeks) apart with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment. Subjects will be contacted by phone 7 days (± 2 days) after their first treatment for follow-up. Subjects will return to the site after all study treatments have been delivered for two follow-up visits: 6 and 12 weeks (± 2 weeks) following their final study treatment.
The Secondary Efficacy Endpoints as the:
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.
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Exclusion Criteria:
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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.
no arm
Device: other
no arm
Correct Identification of the 12 Weeks Post-final Treatment Photographs From the Baseline Photographs by at Least 2 of the 3 Blinded Reviewers in 75% of the Patients.
visual review of study photographs correctly identifying the temporal order (before and after) of each photograph pair (Baseline and 12 week Post-final treatment)
Time frame: 12 weeks post-final treatment
| Milestone | Treatment |
|---|---|
| Started | 43 |
| Completed | 38 |
| Not completed | 5 |
visual review of study photographs correctly identifying the temporal order (before and after) of each photograph pair (Baseline and 12 week Post-final treatment)
| Participants | Treatment |
|---|---|
| Correct Identification of the 12 Weeks Post-final Treatment Photographs From the Baseline Photographs by at Least 2 of the 3 Blinded Reviewers in 75% of the Patients. | 31 |
Collected over Adverse events were collected during and following each treatment up to 12 weeks post final laser treatment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/43 (0%) | 0/43 (0%) | 43/43 (100%) |
| Event | Treatment |
|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 43/43 |
| EdemaSkin and subcutaneous tissue disorders | 36/43 |
| PurpuraSkin and subcutaneous tissue disorders | 17/43 |
| DiscomfortSkin and subcutaneous tissue disorders | 16/43 |
| Age, Continuous(years) | Treatment |
|---|---|
| Mean | 39.6 ± 14.9 |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 29 |
| Male | 14 |
| Ethnicity (NIH/OMB)(Participants) | Treatment |
|---|---|
| Hispanic or Latino | 10 |
| Not Hispanic or Latino | 33 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 10 |
| Native Hawaiian or Other Pacific Islander | 2 |
| Black or African American | 1 |
| White | 28 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2017 to primary completion in Sep 2018, 13 months.
Results were first posted in Aug 2023, 4 years 10 months after primary completion.
Of 78 interventional studies with no phase under Hypertrophy, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 22. This study's 13 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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