Skin Laxity
Conditions
Brief summary
The purpose of this study is to evaluate histological results of the treatments with the TempSure Firm handpiece on the flanks performed in the CYN20-FIRM-LIPO study.
Detailed description
Up to 10 subjects will be enrolled at up to 3 study centers. Subjects will receive 2 biopsies, 1 biopsy in the treatment area (the flanks) and 1 biopsy outside of the treatment area to serve as a control.
Interventions
DEVICETempSure treatment
Self-controlled, single-arm study using the TempSure device.
Sponsors
Cynosure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
• Subject has completed their participation in the CYN20-FIRM-LIPO study.
Exclusion criteria
* The subject has not had any other treatment in the treatment area after their involvement in the CYN20-FIRM-LIPO study. * The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment Samples With Different Levels of Elastin When Compared to Baseline Samples From the Same Patient | 1 Week (7-10 days) Post Baseline | Sections of skin were removed using the punch biopsy technique to render a microscopic diagnosis. Each specimen was preserved with a fixative and then stained using Hemotoxylin & Eosin, Verhoeff and Masson Red/Fast Green and/or nitroblue tetrazolium chloride (NBTC) staining methods. If using Hemotoxylin & Eosin, Verhoeff and Masson Red/Fast Green staining, samples were assessed and evaluated by the amount of elastin. If using NBTC staining, samples were assessed and evaluated to differentiate between the blue-stained viable cells and the unstained thermally damaged cells. The samples were examined by a qualified pathologist. The visual changes between the treated samples and the control samples were examined, with no typical unit of measure used to quantify the difference. Simply, control and treatment images were compared to each other with a qualitative analysis of the changes. The number of samples with different levels of elastin (control compared to treatment) is reported. |
| Number of Treatment Samples With Different Levels of Dermis Collagen When Compared to Baseline Samples Taken From the Same Patient | 1 Week (7-10 days) Post Baseline | Sections of skin were removed using the punch biopsy technique to render a microscopic diagnosis. Each specimen was preserved with a fixative and then stained using Hemotoxylin & Eosin, Verhoeff and Masson Red/Fast Green and/or nitroblue tetrazolium chloride (NBTC) staining methods. If using Hemotoxylin & Eosin, Verhoeff and Masson Red/Fast Green staining, samples were assessed and evaluated by the amount of collagen. If using NBTC staining, samples were assessed and evaluated to differentiate between the blue-stained viable cells and the unstained thermally damaged cells. The samples were examined by a qualified pathologist. The visual changes between the treated samples and the control samples were examined, with no typical unit of measure used to quantify the difference. Simply, control and treatment images were compared to each other with a qualitative analysis of the changes. The number of samples with different levels of collagen (control compared to treatment) is reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TempSure Device The TempSure will be used on the flanks during this study.
TempSure treatment: Self-controlled, single-arm study using the TempSure device. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | TempSure Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| FitzPatrick Skin Type FitzPatrick Skin Type I | 0 Participants |
| FitzPatrick Skin Type FitzPatrick Skin Type II | 0 Participants |
| FitzPatrick Skin Type FitzPatrick Skin Type III | 1 Participants |
| FitzPatrick Skin Type FitzPatrick Skin Type IV | 4 Participants |
| FitzPatrick Skin Type FitzPatrick Skin Type V | 1 Participants |
| FitzPatrick Skin Type FitzPatrick Skin Type VI | 1 Participants |
| Race/Ethnicity, Customized African American | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 4 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 4 / 7 | 4 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
Number of Treatment Samples With Different Levels of Dermis Collagen When Compared to Baseline Samples Taken From the Same Patient
Sections of skin were removed using the punch biopsy technique to render a microscopic diagnosis. Each specimen was preserved with a fixative and then stained using Hemotoxylin & Eosin, Verhoeff and Masson Red/Fast Green and/or nitroblue tetrazolium chloride (NBTC) staining methods. If using Hemotoxylin & Eosin, Verhoeff and Masson Red/Fast Green staining, samples were assessed and evaluated by the amount of collagen. If using NBTC staining, samples were assessed and evaluated to differentiate between the blue-stained viable cells and the unstained thermally damaged cells. The samples were examined by a qualified pathologist. The visual changes between the treated samples and the control samples were examined, with no typical unit of measure used to quantify the difference. Simply, control and treatment images were compared to each other with a qualitative analysis of the changes. The number of samples with different levels of collagen (control compared to treatment) is reported.
Time frame: 1 Week (7-10 days) Post Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Study Participants | Number of Treatment Samples With Different Levels of Dermis Collagen When Compared to Baseline Samples Taken From the Same Patient | 0 biopsy samples |
Primary
Number of Treatment Samples With Different Levels of Elastin When Compared to Baseline Samples From the Same Patient
Sections of skin were removed using the punch biopsy technique to render a microscopic diagnosis. Each specimen was preserved with a fixative and then stained using Hemotoxylin & Eosin, Verhoeff and Masson Red/Fast Green and/or nitroblue tetrazolium chloride (NBTC) staining methods. If using Hemotoxylin & Eosin, Verhoeff and Masson Red/Fast Green staining, samples were assessed and evaluated by the amount of elastin. If using NBTC staining, samples were assessed and evaluated to differentiate between the blue-stained viable cells and the unstained thermally damaged cells. The samples were examined by a qualified pathologist. The visual changes between the treated samples and the control samples were examined, with no typical unit of measure used to quantify the difference. Simply, control and treatment images were compared to each other with a qualitative analysis of the changes. The number of samples with different levels of elastin (control compared to treatment) is reported.
Time frame: 1 Week (7-10 days) Post Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Study Participants | Number of Treatment Samples With Different Levels of Elastin When Compared to Baseline Samples From the Same Patient | 0 biopsy samples |