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The purpose of this study is to compare the tolerability of the application of a combination of a serum containing human bone marrow stem cell derived growth factor (SCR Complex) and cytokines and a botanical lipid-based occlusive (Bio Cel) immediately following fractional radiofrequency treatment using the Venus Viva versus standard of care.
Randomized, open-label, multi-centre study to evaluate the tolerability of the application of a combination of a serum containing human bone marrow stem cell derived growth factor and cytokines (SCR Complex™) and a botanical lipid based occlusive (Bio Cel™) following facial fractional RF treatments using the Venus Viva™ SR system. Each subject will receive 2 treatments separated by a 3-week interval. Subjects will complete a VAS and Tolerability Scale immediately following each treatment. Telephone follow-up calls by the site will ask the subject to respond to the Self-Report Adverse Event Questionnaire 24 and 72 hours after the first treatment and 24 hours after the second treatment. Subjects will complete a Home Tolerability Scale 24 and 72 hours after the first treatment and 24 hours after the second treatment. Subjects will return for the final FU visit and be asked to respond to the Self-Report Adverse Event Questionnaire and complete the Home Tolerability Scale for 72 hours. The investigator will also evaluate the subject's improvement using the GAIS at this visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical combination therapy | Experimental | Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face |
|
| Standard of care | No Intervention | No topical therapies for 24 hours post-radio-frequency treatment of the face |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical combination therapy | Other |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment | Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is. | 24hr post treatment one |
| Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment | Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is. | 72 hrs post treatment one |
| Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment | Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is. | 24hr post treatment two |
| Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment | Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is. | 72hr post treatment two |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale | 10 cm Subject discomfort scale where 10 cm indicates 'Pain as bad as it can be' and 0 cm indicates there is no pain at all associated with the application of the treatment. Zero pain means a better outcome. Subjects were categorized as to having no pain (0 - 0.4cm), mild pain (0.5 - 4.4cm), moderate pain (4.5 - 7.4cm) and severe pain (7.5 - 10cm). | immediately following radio-frequency treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph L Reiz, BSc | Venus Concept Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. George Taylor | Newport Beach | California | 92660 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical Combination Therapy | Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face Topical combination therapy |
| FG001 | Standard of Care | No topical therapies for 24 hours post-radio-frequency treatment of the face |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topical Combination Therapy | Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face Topical combination therapy |
| BG001 | Standard of Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The protocol was amended to include subjects >/= 75 years of age. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment | Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is. | Not all subjects only responded to telephone request for tolerability at 24 hours | Posted | Count of Participants | Participants | 24hr post treatment one |
|
The study collected adverse event data for 3 months 4 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topical Combination Therapy | Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face Topical combination therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yoni Iger | Venus Concept Ltd | 888-907-0115 | yoni@venusconcept.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2016 | Apr 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Fitzpatrick Wrinkle and Elastosis Scale | Investigator assessment of improvement in wrinkles and elastosis where Class I indicates fine wrinkles, Class II indicates fine to moderate depth wrinkles with a moderate number of lines and Class III indicates fine to deep wrinkles, numerous lines with or without redundant skin folds with a score of 1 - 3 (Mild) indicates fine texture changes with subtly accentuated skin lines, a score of 4 - 6 (Moderate) indicates distinct papular elastosis ([indvidual papules with yellow translucency under direct lighting] and dyschromia and a score of 7 - 9 (Severe) indicates multipapular and confluent elastosis [thickened yellow and pallid] approaching or consistent with cutis rhomboidalis. A lower class and a lower score means a better outcome. Subjects were divided into 3 categories - No change in FWES score, change in FWES score by one and non-evaluable. | change in appearance of wrinkles from baseline and at end of study, average of 24 days |
| Global Aesthetic Improvement Scale | Investigator assessment of aesthetic improvement where 1 shows exceptional improvement, 2 shows very improved, 3 shows improvement, 4 shows unchanged and 5 indicates that the subject appearance has worsened. A low score means a better outome. Subjects were categorized to either GAIS improved or GAIS no change. | change in skin appearance between baseline and at end of study, average of 24 days |
| Adverse Event |
|
| Withdrawal by Subject |
|
No topical therapies for 24 hours post-radio-frequency treatment of the face |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Tolerability of Initial Treatment | The primary endpoint of the study is the tolerability of the combination treatment vs standard of care treatment. This baseline measure of tolerability to the first treatment is the measure from which succeeding treatments were compared to . | Not all subjects had the initial treatment tolerability reported. Twenty-three subjects in each of the treatment groups reported the initial tolerability. | Count of Participants | Participants |
|
No topical therapies for 24 hours post-radio-frequency treatment of the face |
|
|
| Primary | Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment | Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is. | Posted | Count of Participants | Participants | 72 hrs post treatment one |
|
|
|
| Primary | Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment | Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is. | Posted | Count of Participants | Participants | 24hr post treatment two |
|
|
|
| Primary | Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment | Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is. | Posted | Count of Participants | Participants | 72hr post treatment two |
|
|
|
| Secondary | Visual Analog Scale | 10 cm Subject discomfort scale where 10 cm indicates 'Pain as bad as it can be' and 0 cm indicates there is no pain at all associated with the application of the treatment. Zero pain means a better outcome. Subjects were categorized as to having no pain (0 - 0.4cm), mild pain (0.5 - 4.4cm), moderate pain (4.5 - 7.4cm) and severe pain (7.5 - 10cm). | Not all subjects reported VAS for each treatment. | Posted | Count of Participants | Participants | No | immediately following radio-frequency treatment |
|
|
|
| Secondary | Fitzpatrick Wrinkle and Elastosis Scale | Investigator assessment of improvement in wrinkles and elastosis where Class I indicates fine wrinkles, Class II indicates fine to moderate depth wrinkles with a moderate number of lines and Class III indicates fine to deep wrinkles, numerous lines with or without redundant skin folds with a score of 1 - 3 (Mild) indicates fine texture changes with subtly accentuated skin lines, a score of 4 - 6 (Moderate) indicates distinct papular elastosis ([indvidual papules with yellow translucency under direct lighting] and dyschromia and a score of 7 - 9 (Severe) indicates multipapular and confluent elastosis [thickened yellow and pallid] approaching or consistent with cutis rhomboidalis. A lower class and a lower score means a better outcome. Subjects were divided into 3 categories - No change in FWES score, change in FWES score by one and non-evaluable. | Posted | Count of Participants | Participants | change in appearance of wrinkles from baseline and at end of study, average of 24 days |
|
|
|
| Secondary | Global Aesthetic Improvement Scale | Investigator assessment of aesthetic improvement where 1 shows exceptional improvement, 2 shows very improved, 3 shows improvement, 4 shows unchanged and 5 indicates that the subject appearance has worsened. A low score means a better outome. Subjects were categorized to either GAIS improved or GAIS no change. | Posted | Count of Participants | Participants | change in skin appearance between baseline and at end of study, average of 24 days |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Standard of Care | No topical therapies for 24 hours post-radio-frequency treatment of the face | 0 | 24 | 0 | 24 | 0 | 24 |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Initial Treatment - Having no opinion |
|
| Initial treatment - Intolerable |
|
| Initial treatment - Very intolerable |
|
| Tx 1 at 72 hr Having No Opinion |
|
| Tx 1 at 72 hr InTolerable |
|
| Tx 1 at 72 hr Very Intolerable |
|
| Tx 2 at 24 hr Having No Opinion |
|
| Tx 2 at 24 hr InTolerable |
|
| Tx 2 at 24 hr Very Intolerable |
|
| Tx 2 at 72 hr Having No Opinion |
|
| Tx 2 at 72 hr InTolerable |
|
| Tx 2 at 72 hr Very Intolerable |
|
| Mild Pain (0.5 - 4.4 cm) |
|
| Moderate Pain (4.5 - 7.4 cm) |
|
| Severe Pain (7.5 - 10 cm) |
|
| Treatment 2 |
|
|
| Non-evaluable |
|