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

Venus Concept

Status: Completed

Conditions: Skin Disorders

Treatments: Other: Topical combination therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02896569

CS0116

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Topical combination therapy

Experimental 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

Treatment:

Other: Topical combination therapy

Standard of care

No Intervention group

Description:

No topical therapies for 24 hours post-radio-frequency treatment of the face