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

Skin Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896569
• Other study ID #: CS0116
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: February 27, 2017

Study information

• Verified date: October 2020
• Source: Venus Concept
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 27, 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Skin Diseases
• Skin Disorders

Intervention

Other:
• Topical combination therapy

Locations

Country	Name	City	State
United States	Dr. George Taylor	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Venus Concept

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	24hr post treatment one
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.	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.	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.	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).	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.	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.	change in skin appearance between baseline and at end of study, average of 24 days