Trial Outcomes & Findings for Tolerability of Using a Post-Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation (NCT NCT02896569)
NCT ID: NCT02896569
Last Updated: 2020-11-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
24hr post treatment one
Results posted on
2020-11-03
Participant Flow
Participant milestones
| Measure |
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
|
Standard of Care
No topical therapies for 24 hours post-radio-frequency treatment of the face
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
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
|
Standard of Care
No topical therapies for 24 hours post-radio-frequency treatment of the face
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
3
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Not all subjects had the initial treatment tolerability reported. Twenty-three subjects in each of the treatment groups reported the initial tolerability.
Baseline characteristics by cohort
| Measure |
Topical Combination Therapy
n=25 Participants
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
|
Standard of Care
n=24 Participants
No topical therapies for 24 hours post-radio-frequency treatment of the face
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=49 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=25 Participants
|
23 Participants
n=24 Participants
|
45 Participants
n=49 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=25 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=49 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=25 Participants
|
24 Participants
n=24 Participants
|
47 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=25 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=25 Participants
|
22 Participants
n=24 Participants
|
45 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=25 Participants
|
3 Participants
n=24 Participants
|
6 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=25 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=49 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=25 Participants
|
16 Participants
n=24 Participants
|
37 Participants
n=49 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=25 Participants
|
4 Participants
n=24 Participants
|
5 Participants
n=49 Participants
|
|
Tolerability of Initial Treatment
Initial treatment - Very Tolerable
|
11 Participants
n=23 Participants • Not all subjects had the initial treatment tolerability reported. Twenty-three subjects in each of the treatment groups reported the initial tolerability.
|
7 Participants
n=23 Participants • Not all subjects had the initial treatment tolerability reported. Twenty-three subjects in each of the treatment groups reported the initial tolerability.
|
18 Participants
n=46 Participants • Not all subjects had the initial treatment tolerability reported. Twenty-three subjects in each of the treatment groups reported the initial tolerability.
|
|
Tolerability of Initial Treatment
Initial Treatment - Tolerable
|
11 Participants
n=23 Participants • Not all subjects had the initial treatment tolerability reported. Twenty-three subjects in each of the treatment groups reported the initial tolerability.
|
16 Participants
n=23 Participants • Not all subjects had the initial treatment tolerability reported. Twenty-three subjects in each of the treatment groups reported the initial tolerability.
|
27 Participants
n=46 Participants • Not all subjects had the initial treatment tolerability reported. Twenty-three subjects in each of the treatment groups reported the initial tolerability.
|
|
Tolerability of Initial Treatment
Initial Treatment - Having no opinion
|
1 Participants
n=23 Participants • Not all subjects had the initial treatment tolerability reported. Twenty-three subjects in each of the treatment groups reported the initial tolerability.
|
0 Participants
n=23 Participants • Not all subjects had the initial treatment tolerability reported. Twenty-three subjects in each of the treatment groups reported the initial tolerability.
|
1 Participants
n=46 Participants • Not all subjects had the initial treatment tolerability reported. Twenty-three subjects in each of the treatment groups reported the initial tolerability.
|
|
Tolerability of Initial Treatment
Initial treatment - Intolerable
|
0 Participants
n=23 Participants • Not all subjects had the initial treatment tolerability reported. Twenty-three subjects in each of the treatment groups reported the initial tolerability.
|
0 Participants
n=23 Participants • Not all subjects had the initial treatment tolerability reported. Twenty-three subjects in each of the treatment groups reported the initial tolerability.
|
0 Participants
n=46 Participants • Not all subjects had the initial treatment tolerability reported. Twenty-three subjects in each of the treatment groups reported the initial tolerability.
|
|
Tolerability of Initial Treatment
Initial treatment - Very intolerable
|
0 Participants
n=23 Participants • Not all subjects had the initial treatment tolerability reported. Twenty-three subjects in each of the treatment groups reported the initial tolerability.
|
0 Participants
n=23 Participants • Not all subjects had the initial treatment tolerability reported. Twenty-three subjects in each of the treatment groups reported the initial tolerability.
|
0 Participants
n=46 Participants • Not all subjects had the initial treatment tolerability reported. Twenty-three subjects in each of the treatment groups reported the initial tolerability.
|
PRIMARY outcome
Timeframe: 24hr post treatment onePopulation: Not all subjects only responded to telephone request for tolerability at 24 hours
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.
Outcome measures
| Measure |
Topical Combination Therapy
n=22 Participants
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
|
Standard of Care
n=21 Participants
No topical therapies for 24 hours post-radio-frequency treatment of the face
|
|---|---|---|
|
Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment
Tx 1 at 24 hr Very Tolerable
|
15 Participants
|
18 Participants
|
|
Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment
Tx 1 at 24 hr Tolerable
|
7 Participants
|
3 Participants
|
|
Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment
Tx 1 at 24 hr Having No Opinion
|
0 Participants
|
0 Participants
|
|
Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment
Tx 1 at 24 hr InTolerable
|
0 Participants
|
0 Participants
|
|
Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment
Tx 1 at 24 hr Very Intolerable
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 72 hrs post treatment oneTolerability 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.
Outcome measures
| Measure |
Topical Combination Therapy
n=20 Participants
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
|
Standard of Care
n=18 Participants
No topical therapies for 24 hours post-radio-frequency treatment of the face
|
|---|---|---|
|
Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment
Tx 1 at 72 hr - Very Tolerable
|
17 Participants
|
17 Participants
|
|
Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment
Tx 1 at 72 hr - Tolerable
|
3 Participants
|
0 Participants
|
|
Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment
Tx 1 at 72 hr Having No Opinion
|
0 Participants
|
0 Participants
|
|
Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment
Tx 1 at 72 hr InTolerable
|
0 Participants
|
1 Participants
|
|
Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment
Tx 1 at 72 hr Very Intolerable
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 24hr post treatment twoTolerability 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.
Outcome measures
| Measure |
Topical Combination Therapy
n=21 Participants
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
|
Standard of Care
n=18 Participants
No topical therapies for 24 hours post-radio-frequency treatment of the face
|
|---|---|---|
|
Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment
Tx 2 at 24 hr - Very Tolerable
|
18 Participants
|
14 Participants
|
|
Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment
Tx 2 at 24 hr - Tolerable
|
3 Participants
|
4 Participants
|
|
Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment
Tx 2 at 24 hr Having No Opinion
|
0 Participants
|
0 Participants
|
|
Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment
Tx 2 at 24 hr InTolerable
|
0 Participants
|
0 Participants
|
|
Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment
Tx 2 at 24 hr Very Intolerable
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 72hr post treatment twoTolerability 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.
Outcome measures
| Measure |
Topical Combination Therapy
n=21 Participants
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
|
Standard of Care
n=18 Participants
No topical therapies for 24 hours post-radio-frequency treatment of the face
|
|---|---|---|
|
Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment
Tx 2 at 72 hr - Very Tolerable
|
19 Participants
|
17 Participants
|
|
Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment
Tx 2 at 72 hr - Tolerable
|
2 Participants
|
1 Participants
|
|
Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment
Tx 2 at 72 hr InTolerable
|
0 Participants
|
0 Participants
|
|
Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment
Tx 2 at 72 hr Very Intolerable
|
0 Participants
|
0 Participants
|
|
Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment
Tx 2 at 72 hr Having No Opinion
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: immediately following radio-frequency treatmentPopulation: Not all subjects reported VAS for each 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).
Outcome measures
| Measure |
Topical Combination Therapy
n=25 Participants
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
|
Standard of Care
n=23 Participants
No topical therapies for 24 hours post-radio-frequency treatment of the face
|
|---|---|---|
|
Visual Analog Scale
Treatment 1 · No pain (0 - 0.4cm)
|
1 Participants
|
1 Participants
|
|
Visual Analog Scale
Treatment 1 · Mild Pain (0.5 - 4.4 cm)
|
16 Participants
|
13 Participants
|
|
Visual Analog Scale
Treatment 1 · Moderate Pain (4.5 - 7.4 cm)
|
6 Participants
|
7 Participants
|
|
Visual Analog Scale
Treatment 1 · Severe Pain (7.5 - 10 cm)
|
2 Participants
|
2 Participants
|
|
Visual Analog Scale
Treatment 2 · No pain (0 - 0.4cm)
|
2 Participants
|
0 Participants
|
|
Visual Analog Scale
Treatment 2 · Mild Pain (0.5 - 4.4 cm)
|
11 Participants
|
9 Participants
|
|
Visual Analog Scale
Treatment 2 · Moderate Pain (4.5 - 7.4 cm)
|
7 Participants
|
8 Participants
|
|
Visual Analog Scale
Treatment 2 · Severe Pain (7.5 - 10 cm)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: change in appearance of wrinkles from baseline and at end of study, average of 24 daysInvestigator 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.
Outcome measures
| Measure |
Topical Combination Therapy
n=25 Participants
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
|
Standard of Care
n=24 Participants
No topical therapies for 24 hours post-radio-frequency treatment of the face
|
|---|---|---|
|
Fitzpatrick Wrinkle and Elastosis Scale
No change in FWES score
|
23 Participants
|
23 Participants
|
|
Fitzpatrick Wrinkle and Elastosis Scale
FWES score increased by one
|
2 Participants
|
0 Participants
|
|
Fitzpatrick Wrinkle and Elastosis Scale
Non-evaluable
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: change in skin appearance between baseline and at end of study, average of 24 daysInvestigator 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.
Outcome measures
| Measure |
Topical Combination Therapy
n=20 Participants
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
|
Standard of Care
n=23 Participants
No topical therapies for 24 hours post-radio-frequency treatment of the face
|
|---|---|---|
|
Global Aesthetic Improvement Scale
GAIS Improved
|
12 Participants
|
14 Participants
|
|
Global Aesthetic Improvement Scale
GAIS No Change
|
8 Participants
|
9 Participants
|
Adverse Events
Topical Combination Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place