N/A
Completed N=49
Tolerability of Using a Post-Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation
Skin Disorders
Source: ClinicalTrials.gov NCT02896569 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment — 15; 18; 7; 3 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment |
15; 18; 7; 3; 0; 0 | — |
| PRIMARY Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment |
17; 17; 3; 0; 0; 0 | — |
| PRIMARY Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment |
18; 14; 3; 4; 0; 0 | — |
| PRIMARY Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment |
19; 17; 2; 1; 0; 0 | — |
| SECONDARY Visual Analog Scale |
1; 1; 16; 13; 6; 7 | — |
| SECONDARY Fitzpatrick Wrinkle and Elastosis Scale |
23; 23; 2; 0; 0; 1 | — |
| SECONDARY Global Aesthetic Improvement Scale |
12; 14; 8; 9 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02896569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.