Clinical trial NCT01299103: Safety and Efficacy of Single Therapy Versus Double and Triple Therapy of the Pellevé™ Wrinkle Treatment System for the Treatment of Moderate Facial Wrinkles
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appearance of Facial Wrinkles
Keywords: wrinkle
rhytide
Lead sponsor: Ellman International
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will enroll and treat a patients to assess improvement in the appearance of facial wrinkles.

Detailed description: The study will enroll and treat a total of 44 subjects (23 in treatment Group A receiving a single treatment and 21 in treatment Group B receiving two treatments) with moderate facial wrinkles corresponding to a grade of 4-6 on the validated Fitzpatrick Wrinkle Assessment Scale.

Eligibility criteria: 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.

Primary outcomes:
measure: Fitzpatrick Wrinkle Assessment
timeFrame: change in Fitzpatrick Wrinkle Score between baseline and 90 days post treatment assessment.
measure: Adverse Events
timeFrame: 90 days post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chichago
country: United States
facility: DeNova Research Institute
state: Illinois
Study officials:
affiliation: DeNova Research
name: Steven H. Dayan, MD
role: PRINCIPAL_INVESTIGATOR
References: