Tolerability of Using a Post-Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Evaluation of the Tolerability of Using a Post Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation Using the Venus Viva

Conditions
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Skin Disorders

Intervention / Treatment
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* Other: Topical combination therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical combination therapy<br>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 | Other: Topical combination therapy<br> <br> * Other names: Bio Cel;|
| No Intervention: Standard of care<br>No topical therapies for 24 hours post-radio-frequency treatment of the face | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resurfacing, ablation