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

• Sponsor: Venus Concept (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02896569
• Collaborator: (none)
• Enrollment: 49
• Location: 1
• Arms: 2
• Duration (Months): 6.9
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Skin Disorders	Other: Topical combination therapy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of the Tolerability of Using a Post Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation Using the Venus Viva
• Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Feb 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Other: Topical combination therapy; Other Names: SCR Complex Bio Cel
No Intervention: Standard of care No topical therapies for 24 hours post-radio-frequency treatment of the face

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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 Outcome Measures

1. 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).

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. George Taylor	Newport Beach	California	United States	92660

Sponsors and Collaborators

• Venus Concept

Investigators

• Study Director: Joseph L Reiz, BSc, Venus Concept Ltd.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 18, 2016

More Information

Publications

None provided.

• Responsible Party: Venus Concept
• ClinicalTrials.gov Identifier: NCT02896569
• Other Study ID Numbers: CS0116
• First Posted: Sep 12, 2016
• Last Update Posted: Nov 3, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Venus Concept: resurfacing; ablation
• Additional relevant MeSH terms: Skin Diseases

Study Results

Participant Flow

Arm/Group Title	Topical Combination Therapy	Standard of Care
Arm/Group Description	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	No topical therapies for 24 hours post-radio-frequency treatment of the face
Period Title: Overall Study
STARTED	25	24
COMPLETED	21	19
NOT COMPLETED	4	5

Baseline Characteristics

Arm/Group Title	Topical Combination Therapy	Standard of Care	Total
Arm/Group Description	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	No topical therapies for 24 hours post-radio-frequency treatment of the face	Total of all reporting groups
Overall Participants	25	24	49
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	22 88%	23 95.8%	45 91.8%
>=65 years	3 12%	1 4.2%	4 8.2%
Sex: Female, Male (Count of Participants)
Female	23 92%	24 100%	47 95.9%
Male	2 8%	0 0%	2 4.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 8%	2 8.3%	4 8.2%
Not Hispanic or Latino	23 92%	22 91.7%	45 91.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 12%	3 12.5%	6 12.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	1 4.2%	1 2%
White	21 84%	16 66.7%	37 75.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 4%	4 16.7%	5 10.2%
Tolerability of Initial Treatment (Count of Participants)
Initial treatment - Very Tolerable	11 44%	7 29.2%	18 36.7%
Initial Treatment - Tolerable	11 44%	16 66.7%	27 55.1%
Initial Treatment - Having no opinion	1 4%	0 0%	1 2%
Initial treatment - Intolerable	0 0%	0 0%	0 0%
Initial treatment - Very intolerable	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment
Description	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

Outcome Measure Data

Analysis Population Description

Not all subjects only responded to telephone request for tolerability at 24 hours

Arm/Group Title	Topical Combination Therapy	Standard of Care
Arm/Group Description	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	No topical therapies for 24 hours post-radio-frequency treatment of the face
Measure Participants	22	21
Tx 1 at 24 hr Very Tolerable	15 60%	18 75%
Tx 1 at 24 hr Tolerable	7 28%	3 12.5%
Tx 1 at 24 hr Having No Opinion	0 0%	0 0%
Tx 1 at 24 hr InTolerable	0 0%	0 0%
Tx 1 at 24 hr Very Intolerable	0 0%	0 0%

2. Primary Outcome

Title	Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topical Combination Therapy	Standard of Care
Arm/Group Description	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	No topical therapies for 24 hours post-radio-frequency treatment of the face
Measure Participants	20	18
Tx 1 at 72 hr - Very Tolerable	17 68%	17 70.8%
Tx 1 at 72 hr - Tolerable	3 12%	0 0%
Tx 1 at 72 hr Having No Opinion	0 0%	0 0%
Tx 1 at 72 hr InTolerable	0 0%	1 4.2%
Tx 1 at 72 hr Very Intolerable	0 0%	0 0%

3. Primary Outcome

Title	Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topical Combination Therapy	Standard of Care
Arm/Group Description	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	No topical therapies for 24 hours post-radio-frequency treatment of the face
Measure Participants	21	18
Tx 2 at 24 hr - Very Tolerable	18 72%	14 58.3%
Tx 2 at 24 hr - Tolerable	3 12%	4 16.7%
Tx 2 at 24 hr Having No Opinion	0 0%	0 0%
Tx 2 at 24 hr InTolerable	0 0%	0 0%
Tx 2 at 24 hr Very Intolerable	0 0%	0 0%

4. Primary Outcome

Title	Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topical Combination Therapy	Standard of Care
Arm/Group Description	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	No topical therapies for 24 hours post-radio-frequency treatment of the face
Measure Participants	21	18
Tx 2 at 72 hr - Very Tolerable	19 76%	17 70.8%
Tx 2 at 72 hr - Tolerable	2 8%	1 4.2%
Tx 2 at 72 hr Having No Opinion	0 0%	0 0%
Tx 2 at 72 hr InTolerable	0 0%	0 0%
Tx 2 at 72 hr Very Intolerable	0 0%	0 0%

5. Secondary Outcome

Title	Visual Analog Scale
Description	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

Outcome Measure Data

Analysis Population Description

Not all subjects reported VAS for each treatment.

Arm/Group Title	Topical Combination Therapy	Standard of Care
Arm/Group Description	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	No topical therapies for 24 hours post-radio-frequency treatment of the face
Measure Participants	25	23
No pain (0 - 0.4cm)	1 4%	1 4.2%
Mild Pain (0.5 - 4.4 cm)	16 64%	13 54.2%
Moderate Pain (4.5 - 7.4 cm)	6 24%	7 29.2%
Severe Pain (7.5 - 10 cm)	2 8%	2 8.3%
No pain (0 - 0.4cm)	2 8%	0 0%
Mild Pain (0.5 - 4.4 cm)	11 44%	9 37.5%
Moderate Pain (4.5 - 7.4 cm)	7 28%	8 33.3%
Severe Pain (7.5 - 10 cm)	1 4%	2 8.3%

6. Secondary Outcome

Title	Fitzpatrick Wrinkle and Elastosis Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topical Combination Therapy	Standard of Care
Arm/Group Description	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	No topical therapies for 24 hours post-radio-frequency treatment of the face
Measure Participants	25	24
No change in FWES score	23 92%	23 95.8%
FWES score increased by one	2 8%	0 0%
Non-evaluable	0 0%	1 4.2%

7. Secondary Outcome

Title	Global Aesthetic Improvement Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topical Combination Therapy	Standard of Care
Arm/Group Description	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	No topical therapies for 24 hours post-radio-frequency treatment of the face
Measure Participants	20	23
GAIS Improved	12 48%	14 58.3%
GAIS No Change	8 32%	9 37.5%

Adverse Events

Time Frame	The study collected adverse event data for 3 months 4 days.
Arm/Group Title	Topical Combination Therapy		Standard of Care
Arm/Group Description	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		No topical therapies for 24 hours post-radio-frequency treatment of the face
All Cause Mortality
	Topical Combination Therapy		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/24 (0%)
Serious Adverse Events
	Topical Combination Therapy		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Topical Combination Therapy		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/24 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.