Clinical trial NCT02896569: Tolerability of Using a Post-Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation
Official title: Clinical Evaluation of the Tolerability of Using a Post Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation Using the Venus Viva
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Disorders
Keywords: resurfacing
ablation
Lead sponsor: Venus Concept
Sponsor class: INDUSTRY
First posted: 2016-09-12
Enrollment: 49
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment
timeFrame: 24hr post treatment one
measure: Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment
timeFrame: 72 hrs post treatment one
measure: Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment
timeFrame: 24hr post treatment two
measure: Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment
timeFrame: 72hr post treatment two
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: immediately following radio-frequency treatment
measure: Fitzpatrick Wrinkle and Elastosis Scale
timeFrame: change in appearance of wrinkles from baseline and at end of study, average of 24 days
measure: Global Aesthetic Improvement Scale
timeFrame: change in skin appearance between baseline and at end of study, average of 24 days
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Dr. George Taylor
state: California
Study officials:
affiliation: Venus Concept Ltd.
name: Joseph L Reiz, BSc
role: STUDY_DIRECTOR
References: