Safety and Efficacy of Single Therapy Versus Double and Triple Therapy of the Pellevé™ Wrinkle Treatment System for the Treatment of Moderate Facial Wrinkles

Facial Rhytides Clinical Trial

Official title:

A Prospective, Randomized, Open-Label, 3-Arm Parallel Study Comparing the Safety and Efficacy of Single Therapy Versus Double and Triple Therapy Using the Surgitron® Dual RF™ S5 With the Pellevé™ Wrinkle Treatment Handpiece and Pellevé™ Treatment Gel for the Treatment of Moderate Facial Wrinkles in Fitzpatrick Skin Types I - IV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299103
• Other study ID #: PEL-10-02
• Status: Completed
• Phase: N/A
• First received: February 4, 2011
• Last updated: April 18, 2012
• Start date: April 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Ellman International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Independent Review Board
• Study type: Interventional

Clinical Trial Summary

This study compares the safety and efficacy of single therapy versus double therapy using the Pellevé™ Wrinkle Treatment System for the treatment of mild to moderate facial wrinkles in Fitzpatrick Skin Types I - IV. Safety is assessed by analysis of adverse events. Efficacy is assessed by change in Fitzpatrick score for facial wrinkles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

Inclusion Criteria:

• Females 35-60 years of age with Fitzpatrick Skin Color Type I-IV.

• Subjects with clinical evidence of facial wrinkles mild to moderate in severity as specified by a grade 4-6 on the Fitzpatrick Wrinkle Assessment Scale.

• Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.

• Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup).

• Willingness and ability to provide written informed consent prior to performance of any study related procedure.

Exclusion Criteria:

• Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.

• Subjects who have had prior exposure to any hyaluronic acid, or any other filler, injection for any purpose in the 12 months preceding study enrollment through the duration of the study.

• Subjects who have had prior exposure to any botulinum toxin for facial rhytids in the 6 months preceding study enrollment through the duration of the study.

• Subjects who have had a prior cosmetic procedure to improve facial rhytids (i.e., rhytidectomy, periorbital or eyelid/eyebrow surgery, brow lift, CO2/erbium laser resurfacing, Thermage/Thermacool radiofrequency treatment) within 12 months or who have visible scars that may affect evaluation of response and/or quality of photography.

• Ablative skin resurfacing on the glabellar area within the previous 6 months or during the study.

• Retinoid, microdermabrasion, or prescription level glycolic acid treatments within 3 months prior to study participation or during the study.

• Active cut, wound, or infection on the skin.

• Oral Isotretinon within the past 12 months.

• Active HSV-1.

• History of keloids or hypertrophic scarring.

• Existing or history of skin malignancy.

• Any existing skin disease.

• History of collagen or vascular disease.

• Subjects who have implantable pacemaker, automatic implantable defibrillator/ cadioversor (AICD), or any other implantable electric device.

• Subjects who have used, within 30 days, any medication that can cause dermal hypersensitivity or affect skin characteristics.

• History of autoimmune disease.

• History of any disease that inhibits pain sensation.

• History of Diabetes I or II.

• Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.

• Subjects who anticipate the need for surgery or overnight hospitalization during the study.

• Subjects who, in the Investigator's opinion, have a history of poor cooperation, non¬compliance with medical treatment or unreliability.

• Enrollment in any active study involving the use of investigational devices or drugs.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Facial Rhytides
• Facies

Intervention

Device:
• Pelleve Wrinkle Treatment System
comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System

Locations

Country	Name	City	State
United States	DeNova Research Institute	Chichago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ellman International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fitzpatrick Wrinkle Assessment	Subject photos will be evaluated using the 9-point Fitzpatrick Wrinkle Assessment Scale at all follow up visits.	90 days post treatment	No
Primary	Adverse Events	The rate of adverse events occurring in treatment subjects will be assessed.	90 days post treatment	Yes
Secondary	Blinded Fitzpatrick Assessment	Three physicians blinded to study timepoints will score standardized photography for facial wrinkles using the Fitzpatrick Scale.	90 days	No