Skin Disorders
Conditions
Keywords
resurfacing, ablation
Brief summary
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.
Detailed description
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.
Interventions
OTHERTopical combination therapy
Sponsors
Venus Concept
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Undergoing a dermatological procedure requiring ablation and resurfacing of the facial skin utilizing the Venus Viva™ SR system. * Women of child-bearing age are required to be using a reliable method of birth control prior to enrollment and throughout their participation in the study. * Able to tolerate the treatment as determined by a test spot application(s).
Exclusion criteria
* Superficial metal or other implants in the treatment area * Tattoos, permanent makeup, scars or piercings in the treatment area. * Any active condition in the treatment area, such as sores, psoriasis, eczema and rash. * Any surgical procedure in the treatment area within the last three months or before complete healing. * Receiving therapies or medication that may interfere with the study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment | 24hr post treatment one | 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. |
| Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment | 72 hrs post treatment one | 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. |
| Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment | 24hr post treatment two | 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. |
| Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment | 72hr post treatment two | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fitzpatrick Wrinkle and Elastosis Scale | change in appearance of wrinkles from baseline and at end of study, average of 24 days | 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. |
| Global Aesthetic Improvement Scale | change in skin appearance between baseline and at end of study, average of 24 days | 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. |
| Visual Analog Scale | immediately following radio-frequency treatment | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| Standard of Care No topical therapies for 24 hours post-radio-frequency treatment of the face | 24 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Physician Decision | 1 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Topical Combination Therapy | Standard of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 23 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 22 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) White | 21 Participants | 16 Participants | 37 Participants |
| Sex: Female, Male Female | 23 Participants | 24 Participants | 47 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
| Tolerability of Initial Treatment Initial Treatment - Having no opinion | 1 Participants | 0 Participants | 1 Participants |
| Tolerability of Initial Treatment Initial treatment - Intolerable | 0 Participants | 0 Participants | 0 Participants |
| Tolerability of Initial Treatment Initial Treatment - Tolerable | 11 Participants | 16 Participants | 27 Participants |
| Tolerability of Initial Treatment Initial treatment - Very intolerable | 0 Participants | 0 Participants | 0 Participants |
| Tolerability of Initial Treatment Initial treatment - Very Tolerable | 11 Participants | 7 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 24 |
| other Total, other adverse events | 0 / 25 | 0 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 |
Outcome results
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.
Time frame: 24hr post treatment one
Population: Not all subjects only responded to telephone request for tolerability at 24 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment | Tx 1 at 24 hr Tolerable | 7 Participants |
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment | Tx 1 at 24 hr InTolerable | 0 Participants |
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment | Tx 1 at 24 hr Having No Opinion | 0 Participants |
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment | Tx 1 at 24 hr Very Intolerable | 0 Participants |
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment | Tx 1 at 24 hr Very Tolerable | 15 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment | Tx 1 at 24 hr Very Intolerable | 0 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment | Tx 1 at 24 hr Very Tolerable | 18 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment | Tx 1 at 24 hr Tolerable | 3 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment | Tx 1 at 24 hr Having No Opinion | 0 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment | Tx 1 at 24 hr InTolerable | 0 Participants |
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.
Time frame: 72 hrs post treatment one
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment | Tx 1 at 72 hr - Tolerable | 3 Participants |
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment | Tx 1 at 72 hr InTolerable | 0 Participants |
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment | Tx 1 at 72 hr Having No Opinion | 0 Participants |
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment | Tx 1 at 72 hr Very Intolerable | 0 Participants |
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment | Tx 1 at 72 hr - Very Tolerable | 17 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment | Tx 1 at 72 hr Very Intolerable | 0 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment | Tx 1 at 72 hr - Very Tolerable | 17 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment | Tx 1 at 72 hr - Tolerable | 0 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment | Tx 1 at 72 hr Having No Opinion | 0 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment | Tx 1 at 72 hr InTolerable | 1 Participants |
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.
Time frame: 24hr post treatment two
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment | Tx 2 at 24 hr - Tolerable | 3 Participants |
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment | Tx 2 at 24 hr InTolerable | 0 Participants |
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment | Tx 2 at 24 hr Having No Opinion | 0 Participants |
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment | Tx 2 at 24 hr Very Intolerable | 0 Participants |
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment | Tx 2 at 24 hr - Very Tolerable | 18 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment | Tx 2 at 24 hr Very Intolerable | 0 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment | Tx 2 at 24 hr - Very Tolerable | 14 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment | Tx 2 at 24 hr - Tolerable | 4 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment | Tx 2 at 24 hr Having No Opinion | 0 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment | Tx 2 at 24 hr InTolerable | 0 Participants |
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.
Time frame: 72hr post treatment two
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment | Tx 2 at 72 hr - Very Tolerable | 19 Participants |
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment | Tx 2 at 72 hr InTolerable | 0 Participants |
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment | Tx 2 at 72 hr Having No Opinion | 0 Participants |
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment | Tx 2 at 72 hr Very Intolerable | 0 Participants |
| Topical Combination Therapy | Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment | Tx 2 at 72 hr - Tolerable | 2 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment | Tx 2 at 72 hr Very Intolerable | 0 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment | Tx 2 at 72 hr - Very Tolerable | 17 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment | Tx 2 at 72 hr - Tolerable | 1 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment | Tx 2 at 72 hr Having No Opinion | 0 Participants |
| Standard of Care | Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment | Tx 2 at 72 hr InTolerable | 0 Participants |
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.
Time frame: change in appearance of wrinkles from baseline and at end of study, average of 24 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Topical Combination Therapy | Fitzpatrick Wrinkle and Elastosis Scale | No change in FWES score | 23 Participants |
| Topical Combination Therapy | Fitzpatrick Wrinkle and Elastosis Scale | FWES score increased by one | 2 Participants |
| Topical Combination Therapy | Fitzpatrick Wrinkle and Elastosis Scale | Non-evaluable | 0 Participants |
| Standard of Care | Fitzpatrick Wrinkle and Elastosis Scale | Non-evaluable | 1 Participants |
| Standard of Care | Fitzpatrick Wrinkle and Elastosis Scale | No change in FWES score | 23 Participants |
| Standard of Care | Fitzpatrick Wrinkle and Elastosis Scale | FWES score increased by one | 0 Participants |
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.
Time frame: change in skin appearance between baseline and at end of study, average of 24 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Topical Combination Therapy | Global Aesthetic Improvement Scale | GAIS Improved | 12 Participants |
| Topical Combination Therapy | Global Aesthetic Improvement Scale | GAIS No Change | 8 Participants |
| Standard of Care | Global Aesthetic Improvement Scale | GAIS Improved | 14 Participants |
| Standard of Care | Global Aesthetic Improvement Scale | GAIS No Change | 9 Participants |
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).
Time frame: immediately following radio-frequency treatment
Population: Not all subjects reported VAS for each treatment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Topical Combination Therapy | Visual Analog Scale | Treatment 2 | Severe Pain (7.5 - 10 cm) | 1 Participants |
| Topical Combination Therapy | Visual Analog Scale | Treatment 1 | Severe Pain (7.5 - 10 cm) | 2 Participants |
| Topical Combination Therapy | Visual Analog Scale | Treatment 1 | Mild Pain (0.5 - 4.4 cm) | 16 Participants |
| Topical Combination Therapy | Visual Analog Scale | Treatment 2 | No pain (0 - 0.4cm) | 2 Participants |
| Topical Combination Therapy | Visual Analog Scale | Treatment 1 | No pain (0 - 0.4cm) | 1 Participants |
| Topical Combination Therapy | Visual Analog Scale | Treatment 2 | Mild Pain (0.5 - 4.4 cm) | 11 Participants |
| Topical Combination Therapy | Visual Analog Scale | Treatment 1 | Moderate Pain (4.5 - 7.4 cm) | 6 Participants |
| Topical Combination Therapy | Visual Analog Scale | Treatment 2 | Moderate Pain (4.5 - 7.4 cm) | 7 Participants |
| Standard of Care | Visual Analog Scale | Treatment 1 | Moderate Pain (4.5 - 7.4 cm) | 7 Participants |
| Standard of Care | Visual Analog Scale | Treatment 2 | Severe Pain (7.5 - 10 cm) | 2 Participants |
| Standard of Care | Visual Analog Scale | Treatment 1 | No pain (0 - 0.4cm) | 1 Participants |
| Standard of Care | Visual Analog Scale | Treatment 1 | Mild Pain (0.5 - 4.4 cm) | 13 Participants |
| Standard of Care | Visual Analog Scale | Treatment 2 | Moderate Pain (4.5 - 7.4 cm) | 8 Participants |
| Standard of Care | Visual Analog Scale | Treatment 1 | Severe Pain (7.5 - 10 cm) | 2 Participants |
| Standard of Care | Visual Analog Scale | Treatment 2 | No pain (0 - 0.4cm) | 0 Participants |
| Standard of Care | Visual Analog Scale | Treatment 2 | Mild Pain (0.5 - 4.4 cm) | 9 Participants |