Evaluation of Safety and Efficacy of the 3F Applicator (A3F) for Treatment of Facial Wrinkles

NCT01566396 | Completed

• 1 other identifier: PC210117_F, rev. 01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

The 3F Applicator (A3F) is indicated for use in dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. This study was designed in order to evaluate the safety and efficacy of the A3F for treatment of facial wrinkles.

Conditions

Facial Wrinkles

Keywords

Fractional,; RF,; Wrinkles; Safety; Efficacy; treatment

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety of the 3F Applicator (A3F) for treatment of facial wrinkles.

  The safety of using the 3F Applicator (A3F) for treatment of facial wrinkles a will be established by physician's assessment/observation of adverse events. AEs will be tabulated by severity and relation to treatment.

  6 months

Secondary Outcomes (1)

• To evaluate the efficacy of the 3F Applicator (A3F) for treatment of facial wrinkles.

  6 months

Study Arms (1)

A3F

EXPERIMENTAL

A3F, Fractional RF treatment

Device: A3F

Interventions

A3F DEVICE

A3F fractional RF treatments for facial wrinkles

A3F

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject read, understood and signed the Consent Form
• Healthy female/male aged 35 65 years,
• Fitzpatrick wrinkle classification score 3 and above
• Fitzpatrick skin type 2-5
• Subject is capable of reading, understanding and following instructions of the procedure to be applied.
• Subject is able and willing to comply with the treatment and follow-up schedule.

You may not qualify if:

• Subject has a pacemaker or internal defibrillator, implanted neurostimulators or any other internal electric device or patient who had an implant in the past.
• Subject has metal or other implants in the treatment area (Not including dental fillings, implants and crowns).
• Subject has current or history of cancer, especially skin cancer or premalignant moles or is undergoing any form of treatment for active cancer.
• Subject has severe concurrent conditions such as epilepsy, lupus or cardiac disorders.
• Subject has poorly controlled endocrine disorders such as diabetes.
• Subject is female who is pregnant, lactating, or plans to become pregnant during the study period or had given birth less than 6 months ago.
• Subject has an impaired immune system due to immunosuppressive diseases such as HIV or AIDS, or use of immunosuppressive medications.
• Subject has a condition that could be negatively affected by heat, including any history of diseases stimulated by heat, such as recurrent Herpes Simplex (in the treatment area).
• Subject has diminished or exaggerated perception of temperature changes.
• Subject has significant concurrent skin conditions affecting areas to be treated such as sores, hemorrhages or risk of hemorrhages, septic conditions, psoriasis, eczema and rash as well as very dry and fragile skin.
• Subject has history of collagen disorders, keloid formation and abnormal wound healing.
• Subject has had previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial treatment or plans on such treatment during the course of the study, or before complete healing has occurred.
• Subject has had Botox injections in the treatment area within 6 months prior to initial treatment
• Subject has had natural fillers within 9 months prior to initial treatment
• Subject has synthetic fillers, injected chemical substance or gold/plastic threads in the treatment area.

Sponsors & Collaborators

• Pollogen: lead

Study Sites (2)

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Research Across America

Plano, Texas, 75093, United States

Location

Study Officials

• Mira Barki, PhD

  Pollogen Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: March 29, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 19, 2012

Record last verified: 2012-05

Locations

US (2)