An interventional study of Revlite Laser System in Facial Solar Lentigines, sponsored by Cynosure, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-11-30.
Sponsored by Cynosure, Inc. (part of Cynosure Lutronic, Inc.) · Not applicable, Interventional, and Device feasibility
The purpose of this study is to evaluate the effects of the Revlite Laser System for treatment of facial solar lentigines
Prospective facial study using the revlite laser to treat pigmentation caused by sun damage.
28 studies on the registry are indexed under Lentigo; 2 are open to participants now.
This study's enrollment of 10 is below the median of 30 across 25 interventional studies indexed under Lentigo.
Browse Lentigo studies →Cynosure, Inc. is the lead sponsor of 52 studies on the registry; 2 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 16 (76%) have results posted.
First submitted before Cynosure, Inc. became part of Cynosure Lutronic, Inc..
Counted across the registry records on this site, refreshed daily.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Revlite Laser System- 1064nm wavelength will be used on half of the face.
Device: Revlite Laser System
Revlite Laser System- treatment will consist of 1064 nm and 532 nm wavelengths on half of the face.
Device: Revlite Laser System
Revlite Laser System for the Treatment of Facial Solar Lentigines
Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale
Photos taken at baseline will be compared to photos taken 1 month post last treatment to assess the level of improvement using the Global Aesthetic Improvement Scale. This evaluation is blinded. This scale ranges from -1 to 3, where -1 is worsened, 0 is no change, 1 is improved, 2 is much improved, and 3 is very much improved.
Time frame: 1 month post last treatment
Physician Satisfaction Questionnaire
The satisfaction is on a scale ranging from extremely satisfied (6) to extremely dissatisfied (1).
Time frame: 1 month post last treatment
| Milestone | Revlite Laser System |
|---|---|
| Started | 10 |
| Revlite single wavelength | 10 |
| Revlite combo wavelength | 10 |
| Completed | 7 |
| Not completed | 3 |
Photos taken at baseline will be compared to photos taken 1 month post last treatment to assess the level of improvement using the Global Aesthetic Improvement Scale. This evaluation is blinded. This scale ranges from -1 to 3, where -1 is worsened, 0 is no change, 1 is improved, 2 is much improved, and 3 is very much improved.
| Participants | Revlite Laser System Single | Revlite Laser System- Combo |
|---|---|---|
| Very Much Improved | 0 | 1 |
| Much Improved | 3 | 3 |
| Improved | 6 | 4 |
| No Change | 1 | 2 |
| Worse | 0 | 0 |
The satisfaction is on a scale ranging from extremely satisfied (6) to extremely dissatisfied (1).
| score on a scale | Revlite Laser System- Single | Revlite Laser System- Combo |
|---|---|---|
| Physician Satisfaction Questionnaire | 3.70 ± 1.63 | 3.600 ± 1.65 |
Collected over Adverse events occurring will be captured and followed throughout each subject's participation in the study, approximately 8 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Revlite Laser System Single | 0/10 (0%) | 0/10 (0%) | 9/10 (90%) |
| Revlite Laser System Combo | 0/10 (0%) | 0/10 (0%) | 9/10 (90%) |
| Event | Revlite Laser System Single | Revlite Laser System Combo |
|---|---|---|
| RednessSkin and subcutaneous tissue disorders | 9/10 | 9/10 |
| PainNervous system disorders | 5/10 | 5/10 |
| SwellingSkin and subcutaneous tissue disorders | 5/10 | 3/10 |
| CrustingSkin and subcutaneous tissue disorders | 4/10 | 4/10 |
| HypopigmentationSkin and subcutaneous tissue disorders | 1/10 | 0/10 |
| AcneSkin and subcutaneous tissue disorders | 1/10 | 1/10 |
| Age, Categorical(Participants) | Revlite Laser System |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Revlite Laser System |
|---|---|
| Female | 10 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Revlite Laser System |
|---|---|
| Race/Ethnicity — Caucasian | 8 |
| Race/Ethnicity — Hispanic | 2 |
| Fitzpatrick Skin Score(Participants) | Revlite Laser System |
|---|---|
| Fitzpatrick Skin Type I | 1 |
| Fitzpatrick Skin Type II | 7 |
| Fitzpatrick Skin Type III | 2 |
| Fitzpatrick Skin Type IV | 0 |
| Fitzpatrick Skin Type V | 0 |
| Fitzpatrick Skin Type VI | 0 |
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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